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

David Burrow, Acting 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 Chief Executive Officer, PCRS Network, LLC  Read Bio >>

John P. Neal Chief Executive Officer, PCRS Network, LLC
Read Bio >>

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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

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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.

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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

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.

Speakers:

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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

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.

Speaker:

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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? 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.

Speakers:

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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).

Speaker:

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

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 interactive session, participants will look at a five step approach to risk management. Attendees 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.

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Apr
15
11:30 AM11:30

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 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
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

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

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

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
3:30 PM15:30

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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