Monday

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Apr
15
3:30 PM15:30

Why Do Surgical Placebo-Controlled Trials?

In this session, the rationale for surgical placebo-controlled trials will be reviewed. One example of such a trial is the world first randomised placebo-controlled trial to evaluate the efficacy and cost-effectiveness of decompressive surgery for lumbar spinal stenosis, which is currently being conducted in Australia. A variety of techniques have been used to address ethical and safety considerations including the innovative/novel step of recruiting a consumer and ethicist to act in advisory roles to provide input on the practicalities of the study design. 

This session will provide attendees with a high-level overview of the trial together with highlighting key learnings about protocol design, consent form drafting and collection of consent, recruitment of surgeons, working with private healthcare providers, and other relevant site level activities.

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Apr
15
3:30 PM15:30

Practical Aspects of Study Initiation

This session will break down the site-level study initiation process into three main components and organize specific tasks and activities for the clinical research site team to consider. Instructions will also be given on finding online resources and NIH toolkits to decrease start up work.

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Apr
15
2:30 PM14:30

Extreme Make-Over! How the TransCelerate Common Protocol Template Makes Your Job Easier

The Common Protocol Template (CPT) is a harmonized and streamlined approach to the format and content of clinical trial protocols. It aims to ease interpretation by the study sites and global regulatory authorities while enabling downstream automation of many clinical processes and aligning to industry data standards. TransCelerate developed the CPT with input from investigators, study coordinators, members of IRBs, IECs, the TransCelerate CRO Forum, and regulatory authorities. The CPT includes a common structure, proposed model text, and regulator-accepted endpoint definitions that may be used across protocols with little to no editing at the discretion of the user. Participants will understand how the CPT frees up valuable clinic time by allowing easier access to information that helps researchers assess a protocol and decreases site training time thus allowing more time for patient care.

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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
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

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

ACRP ICH Gap Analysis: Are You Ready for the Certification Exam? (Part II)

This interactive, four hour session (in two parts) will navigate you through the main ICH guidelines (E2a, E6 R2, E8, E9, E11) and the Declaration of Helsinki which are noted on the ACRP certification exams. The session will help you create an analysis of where you may need to focus your studies. A discussion of the exam format and valuable strategies for exam preparation will be discussed. This session is not intended for those that are preparing to take the exam in the Spring cycle as this is merely a gap analysis to help prepare you for the format of the exams and where you may want to focus in preparation for any of the ACRP main certification exams (CCRA, CCRC, CPI, ACRP-CP).

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NOTE: This is part two of two. Part I will take place Monday, April 15, 10:15am-12:30pm.

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Apr
15
1:30 PM13:30

Achieving the Clinical Trial Experience and Site-Sponsor Relationship of the Future


During this interactive session, leaders from TransCelerate Member Companies will candidly share their experiences collaborating to create solutions that will bring about innovative change, and address some of our industry’s greatest challenges. They will discuss a suite of initiatives that, using innovative digital efforts, has to potential to transform the end-to-end clinical trial experience. TransCelerate has been developing solutions to allow patients to easily find trials, understand studies and provide consent, participate in trial information exchange, utilize electronic medicine labels, provide feedback on their experiences, and ultimately own their digital medical records. The audience will learn how the use of patient technologies, The Registry of the Future, eConsent, eLabels, and electronic health records can advance clinical research and create the patient experience of the future.

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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

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
11:30 AM11:30

Clinical Research Site 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.

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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
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.

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Apr
15
10:15 AM10:15

ACRP ICH Gap Analysis: Are You Ready for the Certification Exam? (Part I)

This interactive, four hour session (in two parts) will navigate you through the main ICH guidelines (E2a, E6 R2, E8, E9, E11) and the Declaration of Helsinki which are noted on the ACRP certification exams. The session will help you create an analysis of where you may need to focus your studies. A discussion of the exam format and valuable strategies for exam preparation will be discussed. This session is not intended for those that are preparing to take the exam in the Spring cycle as this is merely a gap analysis to help prepare you for the format of the exams and where you may want to focus in preparation for any of the ACRP main certification exams (CCRA, CCRC, CPI, ACRP-CP).

Speakers:

NOTE: This is Part one of two. Part II will take place Monday, April 15 1:30-4:30pm.

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Apr
15
10:15 AM10:15

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

This session is brought to you by a generous educational grant, courtesy of Veeva Systems.

“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? This session was provided at ACRP 2018 and was requested to be brought back as it was a so insightful. The speakers for this session represent the sponsor and site perspective and will engage the attendees with an interactive session designed for all site and sponsor representatives to build on their effective communication strategies.

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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

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

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 two 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
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.

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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

This session will help the physician and clinical research site team develop a better understanding of the regulatory requirements within a Physician-Sponsored Investigational Device Exemption (PS-IDE) trial.  The presenters will discuss the unique challenges that the site may encounter, logistics of running the trial as well as their responsibilities and Sponsor obligations for the trial.

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Apr
15
8:00 AM08:00

'Signature Series' - The Future of Clinical Research: Where We are Heading and What It Means to You

This panel discussion on the future of the clinical research industry features perspectives from U.S. Food and Drug Administration, TransCelerate Biopharma, Inc., and site and CRO leadership. Gain an understanding of what the future might look like for clinical trials, how our panelists are preparing for that future, and how you can prepare yourself.

Featuring Our Expert Panel:

David Burrow, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration  Read Bio >>

David Burrow, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
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Jamie Macdonald , Chief Executive Officer, Parexel International  Read Bio >>

Jamie Macdonald , Chief Executive Officer, Parexel International
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Dr. Dalvir Gill, PhD, Chief Executive Officer, TransCelerate BioPharma, Inc.  Read Bio >>

Dr. Dalvir Gill, PhD, Chief Executive Officer, TransCelerate BioPharma, Inc.
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John P. Neal Founder and Chairman of PCRS  Read Bio >>

John P. Neal Founder and Chairman of PCRS
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