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Apr
13
8:00 AM08:00

Evolution of the Clinical Research Workforce for the Future

Join our expert panel to understand the evolution of roles supporting clinical trials. Gain unique insight into key initiatives underway to shape tomorrow’s workforce, and learn how new advances in operationalizing technology, data, and workflow processes will require new skills and competencies.

Panelists:

Virginia Nido, MSEd, Global Head, Product Development Industry Collaborations, Genentech, a Member of the Roche Group

Virginia Nido, MSEd, Global Head, Product Development Industry Collaborations, Genentech, a Member of the Roche Group

Donald A. Deieso, PhD, Executive Chairman & Chief Executive Officer, WCG

Donald A. Deieso, PhD, Executive Chairman & Chief Executive Officer, WCG

Andy Lee, SVP, Head of Global Clinical Trial Operations, Merck

Andy Lee, SVP, Head of Global Clinical Trial Operations, Merck

Jim Kremidas, Executive Director, ACRP

Jim Kremidas, Executive Director, ACRP

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Apr
13
10:15 AM10:15

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.

Speakers:

 

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Apr
13
10:15 AM10:15

Knock, Knock....FDA is here; Be Prepared for a Regulatory Inspection

What do you do when a regulatory Agency knocks on the door? Turn off the lights? Panic? If you’re prepared, it should be an exercise to ensure your systems are working the way you designed them. We will briefly look at FDA Inspections and how to prepare for the inevitable knock, and discuss resources available to you.

Speaker:

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Apr
13
10:15 AM10:15

How to Create a Culture of Quality at a Research Site

Sites are busy and often overlook quality assurance (QA) and only focus on QA when issues arise or when faced with an audit.  This presentation will describe our experience creating a culture of quality using an integrative approach in a team environment.  Our techniques are easy to implement and include quality assurance checks, office guidelines, checklists and lessons learned.  We will discuss the challenges of implementing a quality management system and how to overcome setbacks.

Speaker:

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Apr
13
10:15 AM10:15

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
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

How would you describe  your CRC-CRA relationship? Do you see opportunities to increase your communication and collaboration? Then this session is for you!

We invite all CRCs, CRAs and site personnel to join this session for a review and discussion of these relationships. Feedback from high performing sites on strategies for collaboration and relationship building will be shared and discussed.

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

Transformational Technologies in Pharma: What’s Here and What’s Coming

Technology is changing at light speed and the automobile, retail, airline, finance and many other industries have made a concerted effort to adapt to such. The pharmaceutical industry has been a lager in adapting to newer technologies and clinical trial processes have evolved very little in two decades. However, the regulatory authorities are embracing an effort to transformation clinical trials and change is now inevitable for sponsors, CROs, clinical sites and patients. How are/will wearables, digital therapeutics, digital medicine, real world data, machine learning, artificial intelligence and telemedicine impacting the future of clinical trials; are we all ready for it – is the real question.

Speaker:

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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

Clinical trials are complex, time sensitive with little room for error.  When conducting concurrent studies with limited resources it can be difficult to ensure quality and timely data collection and data entry for each study.  This can lead to stress for staff and diminish the meaningful work they contribute to improve treatment options in clinical studies.  Providing clear and effective project management can make a successful clinical trial.  Project planning and management are a part of achieving quality clinical data. This session will provide new and current Project Managers with useful tools to streamline their workload and hopefully decrease some of the common stress of the role.

Speaker:

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Apr
13
11:30 AM11:30

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

This session 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; and 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

Smedley Headshot.jpg

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

Source: TEDx Talks

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.

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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

Thinking Ahead: Enterprise-Wide Implementation of a Clinical Research Management System

Duke invested in a new clinical research management system (CRMS) to improve quality and support reworked business processes that create administrative simplicity and operational excellence. The CRMS is the central tool to track the clinical research operations portfolio. Its integration with the electronic IRB system (a 1:1 match on protocols, including exemptions) is critical to understanding the diverse clinical research activities across the institution. This required Duke to: implement system-wide workflows, create pathways for heavy and infrequent users, and develop tools for monitoring non-compliance and data completeness. The CRMS has been integral in helping study teams use standardize workflows. Nearly a year post-go live, this presentation will review key success factors, decision points, challenges and successes of an enterprise-wide adoption of Forte’s CRMS, OnCore.

Speakers:


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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

A Deeper Dive: What Makes a Great CRA

Join the continued discussion from ACRP 2018 session with data from session participants to gain insights regarding skills and competencies of today contrasted to those of tomorrow for a CRA. This session included a 360 perspective and discussion of what makes a great CRA. Through the proposed session discussion and data, it is a conversation to be continued through a deeper dive into a few key areas. These areas include technology skills, regulatory knowledge and RCA competency. During this session, our team will reconvene to discuss and share specific recommendations for how to ensure CRAs, employers of CRAs and research sites engaging with CRAs are best prepared to support and optimize the performance of individuals who are undergoing a shift within a long-established role for our industry.

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

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
13
4:30 PM16:30

Insights from Industry Technology Competency and Adoption Survey – What This Means for You and Your Organization

ACRP and Forte have recognized that there is a critical need improve tech adoption in clinical trial operations and to define and refine the technology-related skill sets and competencies. Such competencies will more effectively adapt and develop job descriptions, hiring practices, and training programs that enable a more tech-savvy and more sustainable workforce. Therefore, the two organizations collaborated to launch the Technology Competency and Adoption survey in early 2019. We will be sharing highlights from the survey results with a focus on discussing:
• Barriers to competency achievement and technology adoption
• How individuals can enhance their individual competency
• Best practices for how organizations can foster improved adoption of clinical research technologies

Speakers:

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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

Seven 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.

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