Apr
12
8:00 AM08:00

Workshop: Clinical Project Management Excellence and Best Practices

When registering for this workshop (additional fee required), please be sure to select “W19-06.”

This eight hour course will provide learners with a solid foundation in clinical project management best practices and standards. By combining Project Management Institute best practices with a focused clinical research application and good communication and leadership skills, learners will leave the course with tangible tools to improve their application of project management principles. The ideal attendee will have experience in project management and a heavy focus of project management in their current role.

Speaker:


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Apr
12
8:00 AM08:00

Workshop: A Clinical Trial Financial Management Review – A Paradigm of Front End and Back End Revenue

When registering for this workshop (additional fee required), please be sure to select “W19-04.”

This session will provide a thorough review of the entire financial process of a clinical trial from a programmatical consideration. How do you manage the budget so when the funds are received, you have your costs covered? Evaluate your budget process while analyzing the paradigm shift occurring with lower dollars in our research program. If you have personnel doing coverage analysis for your site, you will benefit attending this eight hour session!

Speaker:

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Apr
12
8:00 AM08:00

Workshop: Best Practices to Become a Preferred Site

When registering for this workshop (additional fee required), please be sure to select “W19-01.”

Mirror, Mirror, on the wall, who’s the fairest site of all? Most noncompliance stems from inadequate and inconsistent documentation at sites. Learn techniques to better manage your regulatory files and prepare to answer sponsors and inspectors regarding screening/enrollment numbers, subject withdrawal, informed consent, recruitment efforts, delegation of authority, PI oversight, protocol violations and adverse events through the use of adequate source. Explore methods by which one can assess feasibility to determine if a study is a good fit for your site. Tips for managing the regulatory file will be provided through tools/worksheets/templates and interactive activities. Over 200 pages of templates and tools will be provided. These techniques and tools will position your site to be best prepared for a monitoring visit or site audit/inspection. Be prepared and be preferred!

Speakers:

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Apr
12
8:00 AM08:00

Workshop: Let's Get Clinical: A Research Bootcamp

When registering for this workshop (additional fee required), please be sure to select “W19-02.”

This full day pre-conference session is based on the popular and successful “Fundamentals of Research” and “CRC Bootcamp” ACRP training programs. The session includes four modules composed of a didactic session followed by a workshop. The didactic sessions cover a comprehensive yet concise review of the topic along with relevant group discussion. The workshops will follow the educational theme presented in the didactic session prior to dividing into small groups to work on solutions to practical exercises. Several trainers will circulate around the room providing feedback, tips, and comments before a large group debrief with the opportunity for one member of each group to discuss their solutions. The four modules are: 1. Informed Consent 2. Obtaining and Reporting Adverse Events 3. Essential Documents 4. Soft Skills.

Speakers:

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Apr
13
10:15 AM10:15

FDA Inspections: Understand the Process and Manage the Consequences

This interactive program is designed for regulatory professionals who deal with complex issues, need to understand the latest developments, and can contribute their own front-line experiences. We will cover important GCP topics and preparation for audits and regulatory inspections. Bring your own GCP questions and dilemmas. Part 2 will employ hands-on activities to create corrective and preventive Actions (CAPAs), utilizing root cause analysis (RCA) procedures to address FDA citations in warning letters and 483s.

Speakers:

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Apr
13
10:15 AM10:15

How to Create a Culture of Quality at a Research Site

Sites are so busy nowadays that quality assurance is often overlooked and is only a focus when issues arise or when there is an audit. We will describe our experience creating a culture of quality using an integrative approach in a team environment. Our easy to implement techniques include quality assurance checks, office guidelines, checklists, and lessons learned. We will explore the challenges of implementing a quality management system and how to overcome any setbacks.

Speaker:

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Apr
13
10:15 AM10:15

Applying Six-Sigma Tools and Concepts to Your Clinical Research Activities

Lean Six Sigma is a methodology that introduces concepts for identifying and removing the inefficiencies from tasks. The typical tasks that clinical researchers do every day can be improved so that less time is spent and increased quality can be injected. We will provide an overview of what Lean Six Sigma means and how to go about assessing any activity. Small groups will be tasked with a familiar process or task instruction to lean for themselves. Attendees will learn actionable take away tools to apply to their daily activities.

Speaker:

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Apr
13
10:15 AM10:15

Getting Multicenter Studies Under Control with Technology

You’ve just been handed a project: An investigator-initiated study with 20 sites on a tight deadline, and here’s the kicker: It’s up to your small team to manage it on top of all your other work. 

The three panelists before you have all faced this situation… and triumphed. In this session, learn how they did it. Topics explored include:

  • Strategic approaches to spread work equitably across study teams

  • Tips for the most critical phases of your study: Startup, monitoring/QC, ongoing communications and closeout

  • In house tools that give you the leverage to “build it once, use it lots”

  • Purpose-built tools that enable secure collaboration of documents and tasks

  • What I’d do differently next time: Learn from our mistakes

Speakers:


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Apr
13
10:15 AM10:15

Integrating Quality into Investigator-Initiated Clinical Trials

There are many steps that must be taken to assess risk and integrate quality when developing, initiating and conducting a clinical trial. These steps are crucial for every type of clinical trial. This session will describe how to apply those principles to investigator-initiated clinical trials utilizing tips, tools and templates available to help along the way.

Speaker:

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Apr
13
10:15 AM10:15

Building Relationships and Collaboration: Sponsors and Sites

Currently, there is often confusion or lack of understanding regarding the roles of the CRC and CRA. we need to take the time to understand each other's backgrounds and expertise, and then align these competencies in effective collaboration. Taking the time to do this by the CRC and CRA would make the best use of our limited time together promoting a quality and timely work product. We have often heard from CRCs that they look to CRAs as their first point of Sponsor contact, a guide and support, not just a someone to verify data against source documents. CRAs look to CRCs for their expertise at implementing a protocol at the site. How can we maximize our roles to effectively reach our individual goals while supporting each other?

Speakers:

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Apr
13
11:30 AM11:30

The Missing Links in CRA Training: How Do We Fix the Chain?

This session will examine the most frequent errors witnessed at a study site due to lack of/poor training on the part of the Clinical Research Associate. Training tips and remediation ideas along with a comprehensive dialogue on how to improve training will be presented. Session participants will be asked to share their viewpoints and experiences as to what they have seen and implemented at their study sites.

Speakers:

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Apr
13
11:30 AM11:30

Unveiling the Mystery of Quality Tolerance Limits

This session focuses on answering the questions of what quality tolerance limits (QTLs), risk indicators, and thresholds are by defining them and discussing how to establish them. We will look at examples of QTLs, and thresholds and discuss appropriate responses to breaches in the thresholds. In addition, documentation of breaches will be reviewed, reporting expectations and long-term plans for the QTLs, and thresholds. Key take-aways will include examples of QTLs, and thresholds to help one get started with establishing QTLs at their organization.

Speaker:

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Apr
13
11:30 AM11:30

Effective Project Management to Streamline Your Clinical Trial Workload

In clinical trials, studies are complex, time-intensive and leave little to no room for error. Particularly when conducting concurrent studies with limited resources, it can be difficult to ensure quality and timely data collection and entry on every study. This can lead to stress and unhappiness with staff despite the meaningful work they contribute to improve treatment options. Clear and effective project management can make or break the success of a clinical trial, and project planning and management are a key part of achieving quality clinical data.

Speaker:

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Apr
13
11:30 AM11:30

Implementing a Competency-Based Onboarding Program for Clinical Research Nurses and Coordinators

This presentation will provide an overview of the key concepts a clinical research nurse or coordinator should know prior to independently managing their own clinical research project and how they should be incorporated into a clinical research training program. Identifying the right tactics to engage adult learners is often a trial and error process and this presentation will explore multiple methods to provide learners with the content they need to know and the pros and cons of each. Attendees will receive checklists, competency scales and week by week guides used in the onboarding program being utilized at Nationwide Children’s Hospital.

Speaker:

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Apr
13
11:30 AM11:30

Expanded Access vs. “Right to Try”: Navigating Disparate Pathways for Desperate Patients

Expanded access to investigational drugs and devices has been available for decades through special pathways provided by the FDA. More recently, two federal actions have widened this access. 1. A federal law allowing for the "right to try" these same unapproved products has been enacted by US Lawmakers. 2. The previous rules governing expanded access have been modified to streamline the process to expedite such access. How do they differ? How should regulatory and research professional advise and/or assist patients faced with these choices? This session will provide a current and complete description of the two pathways, their advantages and challenges.

Speaker:

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Apr
13
2:00 PM14:00

'Signature Series' – Set Extraordinary Expectations

Kristin Smedley is proof that a change in perception can drive one person to impact an entire field.  Eighteen years ago Kristin was on course to achieve her dream: Teacher of the Year.  However, fate had an unanticipated outcome for her destiny.  Her two sons were diagnosed soon after birth with a rare blindness.

Although Kristin was initially paralyzed with fear of raising two blind children, she launched an extraordinary mission to change their bleak future ahead.   Her children have become popular, accomplished athletes, high achieving students, talented musicians, and International Braille competition finalists.

Kristin credits her boys’ success to the fact that her son Michael, at just three years old, changed her perception of blindness.  That change enabled her to Set Extraordinary Expectations for her sons and ignited their journeys.

In 2011 Kristin founded the only patient organization in the world for her sons’ inherited retinal disease.  The Curing Retinal Blindness Foundation is a global leader in changing what a rare eye disease diagnosis means, and Kristin is a sought after speaker and collaborator in the field.

Kristin will demonstrate how the power of perceptions and expectations drives your outcomes.  Learn the components necessary to ignite your own extraordinary journey through her (often hilarious!) real life stories and examples.  

Featuring Kristin Smedley, Founder of Curing Retinal Blindness Foundation

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Kristin Smedley is an award winning non-profit leader, TEDx speaker, and author—but she never planned on any of that. Kristin did plan to be a great third grade teacher, however her personal path to greatness took an unexpected turn when two of her three children were diagnosed as blind. She had to learn the tools of blindness and build a team of experts that would help her and her boys navigate this path that she had not been trained for. Kristin’s two blind sons are now thriving as gifted high school students, elected student council officials, baseball championship winners, International Braille competition finalists, and social butterflies. Her oldest blind son is thriving at college a thousand miles away from home.

In 2011 Kristin founded the Curing Retinal Blindness Foundation, the only patient organization in the world for her sons’ blindness, CRB1 LCA/RP. Kristin has led the CRBF to raise over $1 Million, introduced the first ever legislation in the United States in Braille, and has moved rare eye diseases from rarely talked about to being discussed in key circles worldwide.  More >>

Book Signing Immediately Following!

Kristin will be available following his ‘Signature Series’ session for a meet-and-greet and book signing.

Her book, Thriving Blind: Stories of Real People Succeeding Without Sight, will be available to purchase at ACRP 2019.

Source: TEDx Talks

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Apr
13
3:15 PM15:15

Detecting and Handling Fraud in Clinical Research

Fraud and fabrication is no laughing matter in the realm of clinical trials. It can be a tall task to take on, it is important that everyone involved in a clinical trial understands their role in detecting and preventing fraud and fabrication. This session will outline the ways in which sponsors and CROs can remain diligent by being aware of signs of possible fraud and fabricated data throughout the course of the study.

Speaker:

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Apr
13
3:15 PM15:15

The Impact of Disruptive Change in the Clinical Trials Industry on Research Sites

As we head towards the end of the second decade of the 21st century a great deal has changed about the way research is done at the site level, particularly as it relates to the many disruptive technology-driven changes that have evolved. Or has it? After 13 years managing sites and taking the investigator view followed by 13 years in the CRO industry taking the sponsor view, the presenter will look at what has changed in over a quarter of century and what the future holds for clinical research sites. In particular he will look at the site landscape through the lens of four, supposedly major, disruptive changes.


Speaker:

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Apr
13
3:15 PM15:15

Implementing Clinical Trial Management Systems: Lessons Learned

This presentation will provide an overview of the key concepts a clinical research nurse or coordinator should know prior to independently managing their own clinical research project and how they should be incorporated into a clinical research training program. Identifying the right tactics to engage adult learners is often a trial and error process and this presentation will explore multiple methods to provide learners with the content they need to know and the pros and cons of each. Attendees will receive checklists, competency scales and week by week guides used in the onboarding program being utilized at Nationwide Children’s Hospital.

Speaker:

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Apr
13
3:15 PM15:15

Risk Management: The Crash Course

Are you prepared for the risk management requirements in ICH GCP E6 (R2)? This session will provide a high-level walk through of quality risk management, the key components of a risk management program, and how to conduct a risk assessment at the system and protocol level. We will review the key steps of the process: risk identification, assessment, control, review, reporting, management, and communication. Having an effective risk management program not only ensures compliance with the ICH GCP E6 R2 requirements, but also ensures continuous improvement strategies for your clinical trials. Practical take-aways will be shared along with sample tools.

Speaker:

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Apr
13
3:15 PM15:15

2019 Regulatory Update

Join us for a stimulating presentation that offers a high level overview of the recent changes to laws, regulations, policies and trends that affect our industry. Many of these are from FRDA and OHRP buy many are intended mostly for healthcare operations that are unintentionally (or intentionally) bleeding over into research operations.

Speaker:

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Apr
13
3:15 PM15:15

Clinical Misconduct: Examples and Implication for your Clinical Staff

The Buck Stops with the PI... or Does It? Regulation states that ultimate responsibility for a clinical trial rests with the principal investigator. This session will provide information on the implications and consequences of investigator and staff misconduct in clinical research. Using case studies and actual findings, participants will learn about clinical trials compliance, what kinds of misconduct have occurred in the past and the consequences of a finding of misconduct. Reasons for committing fraud will be explored.

Speakers:

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Apr
13
4:30 PM16:30

Updates on Fraud, Waste and Abuse in Clinical Research and the False Claims Act

Whistleblower Acts play an important role in detecting fraud, waste and abuse. A person who “knows” of fraud being committed against the government can file a lawsuit and, in some cases, receive a reward for bringing original information about a violation to the government’s attention. Because of the importance of the False Claims Acts in clinical research, this presentation will provide a primer on the Acts, address fraud enforcement trends and the various “hot button” issues in clinical research. It will also discuss how non-compliance compromises not only the financial and operational viability of current trials, but may result in a loss of funding, a risk of fines and penalties imposed by oversight agencies, settlement costs and/or damages arising from actions, and diminution of the organization’s reputation.

Speaker:

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Apr
13
4:30 PM16:30

US FDA Registration Process for Medical Devices

Medical device registration is a complex process, in part because of the wide variety of items that are categorized as medical devices. They may be simple tools used during medical examinations, such as tongue depressors and thermometers, or high-tech life-saving devices that are implanted in the patient, like pacemakers and coronary stents. This session will take a step by step approach to walk attendees though what is required in the registration process. Registration and listing provides the FDA with the location of medical device establishments and the devices manufactured at those establishments. Among other things, this helps the FDA plan facility inspections and increases their ability to prepare for and respond to public health emergencies. Participants of this session will gain an understanding of the requirements of the registration process.

Speaker:

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Apr
13
4:30 PM16:30

7 Breakthrough Behaviors for Clinical Research Project Managers

Clinical Project Managers (CPMs) can spend a considerable amount of time “firefighting”. This talk will present 7 behaviors that CPMs can internalize and demonstrate to prevent firefighting. The discussion will also include real-world examples and tried-and-true techniques that will help avoid some of the pitfalls, along with the hefty benefits garnered when the behaviors are embraced.

Speaker:

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Apr
13
4:30 PM16:30

Write Like an 8th Grader! Improving Readability in Clinical Research

How do you ensure that your clinical research materials are readable for the audiences you want to reach? This session will help you learn how to measure and improve the readability of your clinical research communications to a participant and public-facing audience. We will discuss the importance of readability and explore the pros and cons of tools you can use. Case examples from the Duke Clinical Research Institute including informed consent forms, recruitment materials, and lay summaries will highlight how to use free and existing resources to improve your communication.

Speaker:

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Apr
14
8:00 AM08:00

'Signature Series' – The Reality of Change Leadership

What would happen if you transformed your view on change? What if you learned how to master positive change and lead others through the process? The impact of this transformation will surprise you. Your ability to embrace and engage in meaningful change will extend into all areas of life. The Reality of Change Leadership will become a catalyst for positive change in your organization and beyond.

Featuring Dr. Fred Johnson, CEO & Founder of InitiativeOne

Fred_johnson_site.jpeg

Dr. Fred Johnson is the Chief Executive Officer and Founder of InitiativeOne. 

He has created and implemented Leadership Transformation processes that accelerate positive culture change by helping leaders become more authentic, courageous, open, and human than ever before.

This powerful shift in mindset allows teams to lead change through aligned and focused decision making and problem solving. 

Dr. Johnson has worked with Fortune 500 companies, professional and collegiate sports teams, as well as school districts and universities across the country.

He is passionate about elevating leaders and exponentially impacting the leadership culture of an organization.

Book Signing Immediately Following!

Dr. Johnson will be available following his ‘Signature Series’ session for a meet-and-greet and book signing.

His book, The Reality of Change: Mastering Positive Change is Key to Extraordinary Leadership and Optimal Business Outcomes, will be available to purchase at ACRP 2019, but you can order advance copies today from Amazon in both hardback and digital versions.

Check it Out >>

Source: TEDx Talks

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Apr
14
10:15 AM10:15

Clinical Research Culture and the Impact on Adverse Event Reporting

Site culture is a significant, yet under-addressed factor on the impact of timely and complete adverse event (AE) reporting; a large component of patient safety and execution of quality clinical trials. AE collecting, documenting and reporting seems straightforward process that can be covered with a standard operating procedure. In reality, the process itself is impacted by the site culture and effective communication among all of the employees at the site. Quality sites also have a culture that recognizes that clinical trials and their participants are complex, thus requiring checks and balances between the team. This presentation will define the negative impact of strained site cultures on adverse event reporting, identify internal and external pressures, and strategies for improving culture, communication, and adverse event reporting.

Speakers:

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Apr
14
10:15 AM10:15

Cybersecurity: Is your Data Protected?

Maintaining the confidentiality, integrity, and availability of data and systems is critical in healthcare. A cybersecurity incident could result in the compromise of critical information or systems, disruption of operations, and even harm to patients. For these reasons, multiple layers of security defenses are needed to protect our people, data, devices, systems, and networks. People in all roles need to understand the critical part they play and how to utilize processes and technology to protect our ecosystem.

Speaker:

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Apr
14
10:15 AM10:15

Working Smarter, Not Longer

Looking to find new ways to organize and increase your workload without becoming overwhelmed? This session will break down how you can better understand your strengths and utilize them to improve productivity. We will cover how this can be applied in the patient setting to provide the best care for your patients before, during and after the visit. We will also cover how you can use these skills to improve communication and data deadlines with sponsors. Lastly, this session will cover tips and examples where organization and multitasking can improve the amount of work being completed.

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Apr
14
10:15 AM10:15

An Introduction to Gene Therapy Research

Gene therapy studies are becoming increasingly common as the US FDA and other countries have begun issuing approvals for gene therapies, particularly in the field of oncology. Gene therapy studies pose exciting advancements for clinical research but also involve additional risks and regulatory requirements. Gene therapy studies receiving federal funds or taking place at sites receiving federal funds, require review by both an IRB and an Institutional Biosafety Committee prior to registering with the National Institutes of Health (NIH). Further review may be required by the NIH Recombinant DNA Advisory Committee (RAC). This presentation will summarize the current state of gene therapy research and the associated risks. Attendees will learn how to obtain the necessary regulatory approvals and prepare sites to conduct gene therapy research.

Speaker:

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Apr
14
10:15 AM10:15

Leveraging Technology at the Site: Putting the Humanity back in Clinical Trials

We spend too much time in Clinical Research battling the technology that is supposed to be there to help us. That’s time taken away from caring for the patient. By utilizing available solutions that are designed to align current technologies across siloes, we can ease the burden on the research staff, so that Investigators and staff can get back to the disciplines that drew them to the healing arts in the first place. This session will address the technology options available to sites, and participants should walk away empowered, knowing that it’s not an “either-or”, but an “and”; that they can support the patient and still not be shackled by the technology involved.

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Apr
14
10:15 AM10:15

The Path of Least Resistance: Managing Opposition to Change

One of the biggest challenges to implementing change in an organization is employee resistance to change. This session introduces participants to the challenges and obstacles that resistance poses and presents research-based change management practices to mitigate resistance to change. A real-world case study will be used to demonstrate the principles and will be followed throughout the session. Through structured and guided exercises and small group discussion, participants will have the opportunity to apply the learning to a change they are experiencing in their own organization.

Speakers:

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Apr
14
10:15 AM10:15

Inspection Readiness: Beginning with the End in Mind

Sponsors, CROs, and Investigator sites are all too aware of the stress of preparing for a health authority inspection. The challenge is that most organizations begin preparing for an inspection when a drug is filed for approval or they receive notification of an inspection. The key to a successful inspection is preparing at the start of the study. Ensuring that your Investigator Site File (ISF) and Trial Master File (TMF) are built in a way that the complete documentation tells the story of the study, will ensure that you are ready come inspection day. The session will also include common GCP violations that are evident in the TMF/ISF and can result in findings.

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Apr
14
11:30 AM11:30

Rapid Fire: 8 Hot Topics in Research

This one-hour session will consist of eight, 5-minute presentations, on hot topics in the clinical research industry. The sessions will be designed to differentiate between myth and fact, guidance on hot topics and fun inspirational stories.

Topics include:

  • Communicate with Savvy

  • A Father's Inspiration on Public Speaking

  • 'Certify'ably Confused: Certifying Source Documentation

  • From Project Manager to Project Implementation Specialist

  • Good Cleaning Practices: A Dishwasher's Allegory to Quality in Research

  • Knocking Down The Silos

  • Research Dewey Decimal System: The Ultimate Guide to Organizing Research Administration

  • Sex vs Gender: Demonstrating Respect for Participants Through Inclusive Questioning

  • When Study Communication Goes...WRONG

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Apr
14
11:30 AM11:30

Leading Clinical Research Workforce Transformation

Research affects care. Without clinical research, we have standard of care. However, the clinical research landscape is complicated and increasingly burdensome to clinician scientists. To better handle the evolution of the research landscape, the role of the clinical research professional has become even more important; employing a top-notch clinical research workforce is critical. Our AMC prioritized the role of the workforce by using a competency-based framework, developed by the Joint Taskforce for Clinical Trial Competency (JTF), for many related initiatives: to 1) overhaul job classifications, 2) create advancement through a tiering process, 3) establish a professionals network, 4) align competencies with on-boarding and training, 5) create pipelines for clinical research positions, 6) centralize a hiring service, – all an institution-wide workforce strategic initiative called Workforce Engagement & Resilience (WE-R).

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Apr
14
11:30 AM11:30

Project Review: A Transformational Change in Project Delivery

It is critical to manage the performance on a project through key operational indicator metrics. Those metrics assess the current operational and financial health of the project. The project team is responsible for ensuring the project delivery against the contracted statement of work. Through this ongoing review process, the team is able to proactively identify risks and develop a specific, actionable plan. Key operational indicators are critical during start-up, maintenance and close-out. The project manager is able to share this data with the Sponsor to ensure clear visibility and accountability on the project. The goal is to achieve flawless execution on a project by managing to the scope of work and providing quality deliverables within the required timeline.

Speaker:

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Apr
14
11:30 AM11:30

Vendor Management: Selecting, Budgeting, and Managing

This presentation will focus on selecting the best vendors for a specific study, including vendor costs in the study budget, and how to successfully collaborate with the vendors from startup to close out. (This session will not cover qualification of vendors.) The speaker will review the most common types of vendors needed for clinical research studies, what information each type will request from the study sponsor, and how to develop vendor budgets. There will be a discussion on how to review vendor proposals to determine the best fit for the study. Once selected, the speaker will review methods to ensure oversight of the vendor during the length of the study.

Speaker:

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Apr
14
11:30 AM11:30

Understanding Regulatory Guidance for Gene Therapy Development

It has been a big year for gene therapy. In the past 12 months, three gene therapy products received approval from FDA. In July 2018, FDA Commissioner Scott Gottlieb released a statement on the FDA’s efforts and commitment to advance gene therapy. The statement included the announcement of six new or revised guidance documents related to the development of gene therapy products. In this presentation, Dr. Vaughn will review Commissioner Gottlieb’s statement, provide an overview of the six guidance documents, and discuss the implications for clinical development of new gene therapy products.

Speaker:

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Apr
14
2:00 PM14:00

'Signature Series' – State of the Industry

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Join Kenneth A. Getz, MBA, Director of Sponsored Research Programs & Research Associate Professor, Tufts Center for the Study of Drug Development, as he examines the forces shaping the current and future state of the clinical research industry. Explore the individual dynamics of technology, process, and workforce on the industry and their effect on each other. 

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Apr
14
3:15 PM15:15

Clinical Research Management Transformation: Infrastructure, Process, and Technology

Clinical research program management is highly complex and requires coordination, communication and cooperation among multiple stakeholders, departments, and teams. Improving research management workflows is a priority for research programs. Reviewing organizational capabilities and streamlining multiple systems and workflows throughout the research program infrastructure expedites performance. Transforming research management infrastructure, processes, and technology enables efficiencies, and is key to improving cycle times and reducing redundancies. Identifying and effectively communicating with key stakeholders fosters champions for change and eliminates roadblocks for implementation success. Participants in this Master Session will learn practical, step-by-step transformational strategies and tools, and have the opportunity for hands-on practice using these tools through case studies.

Speakers:

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Apr
14
3:15 PM15:15

Post-ICH GCP E6 R2: Institution/Investigator Qualification and Oversight of External Parties in Clinical Trials

Since the publication and global implementation of ICH GCP E6 R2, Institutions and Investigators are grappling with the appropriate and adequate approaches for qualifying external parties (e.g., testing facilities [clinical laboratories, radiology centers, medical specialists [ophthalmologist]) and implementing oversight of delegated trial-related duties, functions, activities and tasks. This session reviews the requirements and includes a panel discussion with experts in institutional research administration, operations and compliance, GCP compliance and a clinical investigator on how to implement the requirements, and how the sponsor/CRO Study Managers and Site Monitors are to monitor and manage the investigator/site.

Speaker:

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Apr
14
3:15 PM15:15

Scope: What is it and Why Should I Care?

While most of us intuitively understand the concept of scope, many do not firmly understand how project managers use the terms "scope", "scope creep", and "scope change". After defining these terms, we will review parameters that most commonly define the scope of a project from both a sponsor, CRO, and site perspective. The importance of tracking scope changes and monitoring for scope creep will be shown using examples of how these could impact on studies.

Speakers:

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Apr
14
3:15 PM15:15

Who’s on First: Developing the Best Inspection Team

We are participants in the development process, impacting the lives of patients and improving the human condition. Global regulators expect us to comply with requirements to ensure data integrity and subject safety throughout the development life-cycle. When they come to review the processes, paper and people involved we must be ready. This visit is expected with known methods so why is there so much angst for an inspection? Taking a team approach, identify the strengths of your resources and aligning those to an inspection "game plan" brings confidence to any inspection team.

Speaker:

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Apr
14
3:15 PM15:15

The Evolution of Source Documents

This presentation is for a new coordinator or for coordinators who would like a refresher. The presentation will address the creation of comprehensive source documents and how to incorporate source documents within the electronic medical record system without creating more work. Source documentation is critical for obtaining accurate data. The number one cause of FDA 483s reported is that sites are not following the protocol. Therefore, developing well written source documents will provide detailed instructions on the information that must be collected. The presentation will also discuss utilizing the electronic case report form manual to identify additional data points to include in their documentation. Source documents should be organized in such a way that anyone is able to complete a visit without missing essential data points.

Speaker:

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Apr
14
3:15 PM15:15

Identifying, Documenting, and Implementing Corrective Action Plans to Improve Site Compliance from a CRO Perspective

This session will provide an overview on how to appropriately identify, document, and address compliance issues noted at sites, from monitoring and Sponsor perspectives. There will be an overview of common monitor findings and a discussion about appropriate next steps for developing effective CAPAs. The escalation of issues to the Sponsor will be discussed along with how to adequately document compliance issues in monitoring reports and follow-up letters. Possible ways in which the Sponsor can handle noncompliances will be addressed, as well as the consequences and risks to the Sponsor and study if compliance issues are not addressed. The objective of this session will be to review site compliance from a CRO perspective, while also discussing practical and effective corrective actions from both the monitor’s and Sponsor’s view.

Speakers:

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Apr
14
3:15 PM15:15

Regulatory and Legal Changes, the Common Rule, and GDPR: How They Can Impact Study Data Flow Based on Real and Perceived Changes to the Privacy of Information

The session will allow the audience to identify and anticipate compliance issues associated with the privacy concerns around the revised Common Rule. It will help the audience understand the reasons why institutions may require steps to help ensure privacy that will no longer be legally required by the revised Common Rule but may be required by research institutions because of ethical concerns. It will also provide the audience with information on the privacy concerns to anticipate when research involves or could involve data covered by the GDPR.

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Apr
14
4:30 PM16:30

Pediatric Research: FDAs 2017 Adopted Version of ICH E11 Resulting in E11 (R1)

ICH E11 original and R1 both considerably changed the environment of drug development for children. They were written specifically to harmonize, promote, and facilitate high-quality and ethical clinical research for children within the ICH regions, i.e., the United States of America (USA), the European Union (EU), and Japan. In August 2017 several key topics within the E11 (R1) Addendum received new recommendations from the FDA. The scope of the 2000 policies, however, remains unchanged and still apply. In this discussion we will discuss E11 (R1) and the FDA issues pertaining to pediatric research. These topics included ethical considerations, age subgroups, pediatric formulations, and drug development research.

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Apr
14
4:30 PM16:30

Clinical Project Schedule Management: Successful Start-Up Planning

Successful clinical trial projects don’t happen, they require effective planning and processes at both the site and sponsor/CRO to meet timelines. The use of a project management tool, a Work Breakdown Structure (WBS) to define clinical trial start-up tasks, timelines, and assignments is an effective method to improve project success. Instruction on how to implement a WBS for clinical trial start-up planning will be mapped out along with best practices to ensure successful communication between the investigative site departments responsible for timely deliverables to the sponsor/CRO.

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Apr
14
4:30 PM16:30

ALCOA-C Redefined: Writing Effective Site Monitoring Visit Reports

Detailed and accurate documentation, source or otherwise, is crucial in clinical research and yet the site monitoring visit report is often perceived as a "B-list" actor when compared with the superstar, source documentation. Nothing could be further from the truth. The monitoring visit report not only documents observations at the site but is one of the main avenues for communicating important information to key stake holders in the clinical research process: study and site issues to the sponsor and facilitating sponsor oversight of the investigator and clinical study; issues of concern and corrective actions to the site staff, and site GCP compliance to regulatory authorities, especially during an audit. The importance of the monitoring visit report must be understood and guidance provided on how to write it effectively.

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Apr
14
4:30 PM16:30

Legal and Regulatory Changes: A Year in Review

A lot has happened this year! Get up to speed with this overview session designed to bring you the highlights and breaking news since last year's ACRP Conference. How are recent legal and regulatory changes fundamentally affecting research? What should research sites and institutions be ready for in the coming months and years? Get answers to these questions and more through this session's issue-spotting exploration and analysis of changes in laws, regulations, and standards promulgated by FDA, DHHS, the NIH, and ICH.

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Apr
14
4:30 PM16:30

GCP Auditing Techniques: Using the FDA Compliance Program Guidance Manuals (CPGMs)

While GCP Quality Assurance (QA) in clinical research settings is not an FDA regulatory requirement, the FDA, research sites and industry are trending towards implementing quality assurance programs. The ICH E6(R2) guideline also raises expectations for QA and conveys the expectation that GCP auditing will be performed. Do you know what you need to know about quality assurance auditing? Implementing a GCP QA program closes the loop between quality control (QC) and quality management. Learn how QC and QA compliment each other. Together they allow for greater assurance of GCP compliance and that data being presented within a regulatory submission will be accurate and defensible. We will introduce GCP auditing, review the FDA’s CPGM for Investigators, Sponsors and IRBs, and relevant sections of the ICH E6(2) Guideline.

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Apr
15
10:15 AM10:15

Workshop: A Competency-Based Approach to Principal Investigator Responsibilities

When registering for this workshop (additional fee required), please be sure to select “W19-03.”

This course is approved for 5.0 ACRP Contact Hours, 5.0 AMA PRA Category 1 Credit(s)™ for physicians, and 5.0 contact hours for registered nurses (full accreditation details below).

Course Description

This course is based on the new ACRP PI Training program and will provide investigators with resources and strategies to help ensure their oversight and delegation of responsibilities within clinical trials at their site. Participants should be familiar with the FDA Guidance Document: Investigator Responsibilities- Protecting the Rights, Safety, and Welfare of Study Subjects, ICH GCP E6(R2) and The Harmonized Core Competency Framework Version 2.0 developed by the Joint Task Force for Clinical Trial Competency.

A review of the Investigator Responsibilities guidance document and resources available for investigator oversight will be reviewed as well as exercises in conducting and evaluating PI Competencies. Root causes of potential risks in investigator oversight will be discussed in groups and as a large group in order to help each participant to focus their attention on areas lacking oversight and provide key takeaways following the session.

Educational Objectives

After completing this activity, the participant should be better able to:

  • Describe the core elements of key regulatory guidance documents as they relate to the roles and responsibilities of the Principal Investigator

  • List the expectations that regulatory agencies and sponsors have for Principal Investigator oversight of clinical trial conduct and examine whether given situations fulfill these expectations

  • Explain the role, value and purpose of competency guidelines and how they can be used to facilitate the appropriate delegation of responsibilities to other staff

Target Audience

This activity is intended for Physicians engaged in the care of patients within a clinical research trial.

Accreditation Statements

The Association of Clinical Research Professionals (ACRP) provides contact hours for the completion of this live educational activity with the completion of the online evaluation form. These contact hours can be used to meet the ACRP certification maintenance requirement.

joint-provider-1-1.jpeg

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and the Association of Clinical Research Professionals. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

  • Physician Continuing Medical Education

The Postgraduate Institute for Medicine designates this enduring material for a maximum of 5.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

  • Continuing Nursing Education

The maximum number of hours awarded for this Continuing Nursing Education activity is 5.0 contact hours.

For any questions relating to CME (physician) or CNE (registered nurse) certification for this activity, please contact Postgraduate Institute for Medicine at: inquries@pimed.com or (303) 799-1930.

Faculty

Beth Harper
Workforce Innovation Officer
Association of Clinical Research Professionals

Dr. David Morin, MD, FACP, CPI, FACRP
Director of Clinical Research
Holsten Medical Group

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers, and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

Beth Harper: Nothing to Disclose

David Morin: Fees for non-CME/CE Services received directly from a commercial interest: Santaurus

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management.  Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

ADA Statement

Event staff will be glad to assist you with any special needs (i.e., physical, dietary, etc.). Contact ACRP

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Apr
15
10:15 AM10:15

With Great Power Comes Great Responsibility: What to Consider in Conducting the Physician-Sponsored IDE

Physician-Sponsored IDE (PS-IDE) offers an ability for the physicians to design the study to treat patients with the unapproved medical devices without the industry support or oversight. The unapproved devices may be born out of physician’s innovation (new devices) or innovative practice such as using the commercially available devices for unapproved indication (i.e., off-label use) or customizing/modifying the approved devices (altered device is considered a new device). Although there is a lot of freedom for the physician to design and conduct his or her own PS-IDE study, it is important to understand the regulatory requirements in every aspect of the trial that you will be personally responsible for. The study site will also have a unique challenge as it must incorporate sponsor obligations into their practices.

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Apr
15
10:15 AM10:15

CDER BIMO Compliance and Enforcement: What you Need to Know

Back by Popular Demand!

Join FDA personnel from the Center for Drug Evaluation and Research as they discuss key opportunities for the clinical research industry to make their FDA inspection experience a positive one.

FDA’s David Burrow will outline recent inspection trends and identify key strategies to build quality into clinical research in order to prevent critical compliance issues. When problems do occur, inspected entities should be able to respond appropriately.

Take away practical approaches to working with the FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence.

Speaker(s):

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Apr
15
10:15 AM10:15

Big Data, RWD and RWE: What’s the Difference and How is it Changing the Research Landscape ?

Real world data (RWD) involves data collected outside of clinical trials, and produces real world evidence (RWE), becoming actionable when powered by analytics, machine learning & artificial intelligence (AI). RWE provides insight beyond traditional clinical trial data, adding potential to link data from different sources; improve trial efficiency; identify new indications, and a real-world perspective of risks/benefits to make informed decisions beyond traditional clinical trials. This session reviews RWE regulatory and market impact including the updated FDA guidelines requiring RWE use in regulatory decisions and how AI and information exchange can be securely managed. It will also highlight ethical and privacy concerns, reviewing recent big data consent guidelines and how to clinically integrate RWD. This session shows best practices from a clinical setting that has multiple RWE publications.

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Apr
15
10:15 AM10:15

Careers in Clinical Research: Charting a Path for CRO Professionals

A career in clinical research as a CRO professional has many advantages – plentiful demand, good compensation, and the ability to make a positive impact – but investigating and exploring these career opportunities can be difficult for those unfamiliar with contract research organizations. In this presentation, we’ll look at a number of different career path options available at CROs, identify how to get started on these paths, and discuss the skills and knowledge you’ll need to progress along those paths. The presentation will include real world examples including those who start their professional careers at a CRO, those who transition from other jobs and industries, some common career paths, and some not so common ones.

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Apr
15
10:15 AM10:15

You Want Me to Do WHAT? Building Lasting Sponsor/Site Relationships Part Deux

“Coming together is a beginning. Keeping together is progress. Working together is success.” - Henry Ford How do you build a solid sponsor-site working relationship from site identification to closeout and beyond? We introduced this topic at ACRP 2018, but strongly believe it deserves a deeper look, as these relationships can have significant impact on overall study success. Through an interactive session, we aim to identify the framework that builds a successful sponsor-site relationship beyond a single clinical research project.

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Apr
15
10:15 AM10:15

A 5-Step Approach to Device Risk Management

Companies are faced with challenges to make medical devices safe for human use. Risk management is an integral part of the medical device product development lifecycle. It helps medical device developers ensure that the product is reliable, works as expected and causes no harm to the patients, operators or the environment. In other words, the main purpose of the risk management cycle is to reduce or mitigate the chances of failure in the product. In this session participants will look at a five step approach to risk management. In this interactive session participants will gain knowledge into the identification, assessment, evaluation, reduction, control and monitoring of risk that are essential to device risk management. Speakers will provide tools, guidance, and some tips on developing a risk management strategy.

Speakers:

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Apr
15
11:30 AM11:30

EFS is the New OUS Strategy for Early-Phased Medical Device Clinical Trials

This session will provide the participant with several real-world examples of the benefits and risks of conducting early-phased medical device clinical trials, and the strategies involved in optimizing this avenue for regulatory submissions. The participant will obtain tools to develop successful clinical and regulatory strategies for new devices and indications.

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Apr
15
11:30 AM11:30

Why Do Surgical Placebo-Controlled Trials?

Looking to find new ways to organize and increase your workload without becoming overwhelmed? This session will break down how you can better understand your strengths and utilize them to improve productivity. We will cover how this can be applied in the patient setting to provide the best care for your patients before, during and after the visit. We will also cover how you can use these skills to improve communication and data deadlines with sponsors. Lastly, this session will cover tips and examples where organization and multitasking can improve the amount of work being completed.

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Apr
15
11:30 AM11:30

GPS for Study Start-Up: The Importance of the Critical Path

Site activation cycle times within the industry are now worse than they were over a decade ago by an average of 4 to 6 weeks. Large, global organizations and small ones alike struggle more than ever to manage the complexities of today's trials and activities on the critical path to activation are always changing. This session will provide practical information on how technologies, best practices, and KPIs can proactively lead life-science organizations towards an entirely different approach to managing study startup.

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Apr
15
1:30 PM13:30

Top Tips for the New Patient Advocacy and Recruitment

Social Media has been a new highly innovative and disruptive technology to many industries, but most importantly clinical trials. Our latest talk on social media breaks down, step-by-step, the latest techniques for patient recruitment, retention and advocacy across the new and old platforms including: Snapchat, Instagram and Facebook.

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Apr
15
1:30 PM13:30

Tools for Advancing Patient-Centered Medical Device Clinical Trials

Industry, FDA and patient groups recognize the importance and value of patient input in the ideation, design, testing and approval of new medical device technologies, but often struggle to elicit and incorporate patient input in a meaningful way. Patients can identify outcomes that are meaningful, risks that they would be willing to tolerate, and practices that can decrease the burden of participation in clinical trials. MDIC is developing a suite of tools to help medical device companies solicit input from patients and patient groups on clinical trial design elements that are aligned with patients’ real-world priorities. Panel attendees will learn about the development of these tools that they can implement in their own clinical trials to develop clinical trials that measure what matters to patients and that patients can complete.

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Apr
15
1:30 PM13:30

Risky Business: Impact of a Risk-Based, Study-Specific Training Program on Research Coordinator Competency in an Emergency Department Setting

This session will describe three important steps to assure RC competency in study procedures at the beginning of a trial: risk assessment, development of a competency based training program, and implementation of that program. Participants will gain an understanding of how to conduct a risk assessment for a clinical trial. They will also learn how to develop and implement this type of program for their studies in order to help increase study procedure awareness and CRC competence. Take-aways will include a training checklist template that can be applied to clinical trial study start-up and a toolkit describing our program.

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Apr
15
1:30 PM13:30

Combating Increasing Complexity of Clinical Trial Data with Expanded Skill Sets and More Teamwork

The number of data sources in clinical trials is increasing and the data coming from those sources are more complex than ever. According to a recent Tufts study, there has been a 20% reduction in EDC as the single source of clinical trials data. What does that mean for the future of data handling and interpretation? It is a broad problem that touches many more areas than just traditional clinical data management. This session will address how skill sets across multiple clinical research disciplines including bioinformatics, statistics, project management and clinical operations will need to broaden, and discuss why greater teamwork, cross-functional collaboration, and minimization of organizational silos are needed.

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Apr
15
1:30 PM13:30

Business Development Best Practices: How to Make your Site Stand Out in an Increasingly Competitive Landscape

With the clinical trial landscape becoming increasingly complex and competitive, it is essential that clinical research sites position themselves in a way to stand out from the “competition.” Factors such as a downturn in the volume of trials being conducted in sites’ primary indications leads to increased competition for each study and a potential downturn in the number of active trials at a site. We will discuss industry trends that impact R&D, the key factors that drive them, and the implications for research sites. We will discuss insightful strategies for staying ahead of the curve, such as therapeutic expansion and increasing patient access within existing key indications. Finally, we will discuss key tactics for developing and strengthening CRO & sponsor relationships in order to become a “go-to” site.

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Apr
15
3:30 PM15:30

Compliant Clinical Trial Contracting: Sponsor and Site Perspectives

Emily Pauli, PHRMD, Director of Research at Clearview Cancer Institute (in Huntsville, AL) and Amy Schmidt, DBA, MBA, CCRC, Compliance Manager, AbbVie (Mettawa, IL) will provide the perspective of both the Sponsor and the Site regarding FMV, SOC and Subject/Travel Reimbursement in clinical study budgets. There are 2 vantage points to contracting and this session will allow the audience to hear from both regarding their processes and how they mirror and possibly conflict....and suggestions how to have a positive outcome for both parties.

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Apr
15
3:30 PM15:30

Practical Aspects of Study Initiation

Purpose: focuses on practical aspects of the preparation and execution of clinical study initiation; identifying and describing key activities, processes, and critical personnel. Methods: provides a practical overview of the significant processes in starting research at a site and a clear understanding of the main components of study initiation: document management, logistics, and people management. Guidance, tools, and resources help the primary investigator and coordinator perform efficiently and understand how their responsibilities tie together with the tasks and duties of others. Conclusions: Organization and adequate time for the initiation process are critical to successful studies. Multiple activities must be orchestrated and performed concurrently, requiring use of study tools and efficient processes. Identification and use of numerous research resources improve efficiency of study initiation and decrease work load and frustration.

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