Virtual ACRP 2021

Jan 12, 2021 ‐ Sep 30, 2021

ACRP 2021 brings the clinical research community together to learn, connect, and explore opportunities to drive excellence in clinical research. The premier education and networking event for clinical research professionals, ACRP 2021 is the ideal venue for learning the practical strategies, best practices, and creative solutions needed to improve clinical trial quality.

Today's environment provides a unique opportunity for year-round education and networking, with a 3-part program held throughout the year.


Are You Ready for 2021: Best Practices for Telemedicine, Modernized Sites, and GDPR

Jan 12, 2021 11:00am ‐ Jan 12, 2021 12:00pm

Identification: COVID01Jan12

Credits: None available.

The rise of COVID-19 has fast-tracked the call for innovative clinical trial solutions and about whether the traditional Sponsor-PI-Patient centric model is sustainable. Discussions of an alternative model, hybrid clinical trials, would combine elements of both centralized and decentralized systems while also leaving the door open for new technologies. But what should the patient experience in a proposed hybrid model? What could the role of advanced technology such as AI, digital patient recruitment and mobile apps be? How would decision making and stakeholder collaboration be impacted? Explore these issues and discuss best practices you can implement in 2021.

Learning Objectives:
  • Identify the feasibility and best practices of hybrid clinical trials.
  • List solutions, methods and possible standards that hybrid clinical trials offer which can still result in desirable outcomes.
  • Gain an understanding of what roles and challenges different stakeholders face when it comes to hybrid clinical trials.
  • Al Pacino, President & CEO, BlueCloud by HealthCarePoint

Expanding Clinical Research in the Midst of a Pandemic: Lessons Learned and Key Takeaways

Jan 12, 2021 12:15pm ‐ Jan 12, 2021 1:15pm

Identification: COVID02Jan12

Credits: None available.

When the world is changing by the minute in the middle of a pandemic, you hold on tight and get ready for a wild ride. Join this session to learn how to expand research operations utilizing remote technology and existing resources and how the Medical University of South Carolina used this approach to activate a COVID-19 study in our rural research naive hospitals in under one week. Hear lessons learned and how the team adapted and overcame barriers to ensure the needs of the community were met.

Learning Objectives:
  • Assess existing research resources available to mobilize for research expansion activities.
  • Become familiar with the framework needed to create a research expansion plan.
  • Recognize the importance of evaluating outcomes to identify when plan adjustments are needed.
  • Amanda Cameron, MPH, CPH, CCRP, Trial Innovation Network Program Manager, Medical University of South Carolina
  • Signe Denmark, MS, CCRP, Associate Director Research Opportunities & Collaborations, Medical University of South Carolina
  • Amy Gandy, SCTR, Laboratories Manager, Medical University of South Carolina

techXpo Session: The Impact of Brexit and COVID-19 on Clinical Research Data Processing in the EU/UK

Jan 12, 2021 1:30pm ‐ Jan 12, 2021 2:30pm

Identification: COVID03Jan12

Credits: None available.

This session is presented by the DPO Centre, Ltd.

Join this 30-minute discussion of the data protection challenges relating to the handling of sensitive personal data of EU and UK trial participants, the effect of Brexit, such as the need to appoint EU and UK Representatives, and how COVID-19 has bought data protection to the forefront of people’s minds.

NOTE: This session does NOT offer ACRP Contact Hours.

Learning Objectives:
  • Considerations when processing EU and/or UK trial participants’ personal data.
  • Understand when EU and UK Representation is required.
  • Considerations following Brexit and the spotlight that COVID-19 has put on data protection.

Sponsor Oversight of Decentralized Clinical Trials

Jan 13, 2021 11:00am ‐ Jan 13, 2021 12:00pm

Identification: COVID01Jan13

Credits: None available.

Explore decentralized clinical trials (DCT) and the oversight role of the sponsor. During COVID-19, many trials have been modified and changed to account for the inability to interact with subjects in person and many organizations have moved to a decentralized architecture. Session participants will: understand the regulations pertaining to decentralized clinical trials, learn the perceived benefits and challenges of a DCT, and discuss remote monitoring of DCTs.

Learning Objectives:
  • Understand the regulations pertaining to decentralized clinical trials.
  • Learn the perceived benefits and challenges of a DCT.
  • Discuss remote monitoring of DCTs.
  • Eric Pittman, MBA, Program Division Director, U.S. Food and Drug Administration

Managing Teams through a Pandemic: Lessons Learned and Lasting Impacts

Jan 13, 2021 12:15pm ‐ Jan 13, 2021 1:15pm

Identification: COVID02Jan13

Credits: None available.

Staff cuts. Furloughs. Realignments of roles and responsibilities. Pivoting to new SOPs and technologies. Remote work as the “new normal.” COVID-19 caused major disruptions in the clinical research workforce.

In this panel session, leadership from sites, sponsors, and CROs will share what they learned while navigating this unprecedented workforce shake-up. They’ll share changes that were thrust upon their teams, what worked, what didn’t – and most importantly, the potential lasting impacts the pandemic is likely to have on the workforce.

  • Abby Statler, Director of Research Quality and Safety, Dartmouth-Hitchcock Medical Center
  • Jennifer Sheller, BS, MPH, North America Regional Head, Global Clinical Trial Operations, Merck
  • Jim Kremidas, Executive Director, ACRP
  • Asha Collins, Head of US, Country Clinical Operations, Genentech

techXpo Session: eSource: Why This is the Platform of the Future

Jan 13, 2021 1:30pm ‐ Jan 13, 2021 2:30pm

Identification: COVID03Jan13

Credits: None available.

This session is presented by Clinical Research IO.

Sites have been adopting eSource for the past several years, as a natural extension of their steady technology adoption. Initially, eSource was thought of as a discreet, stand-alone category of software. But several recent trends point toward eSource becoming an actual platform for industry transformation.

Join experts from Clinical Research IO to explore how several independent trends in research will make eSource a platform technology for sites:

1. The adoption of de-centralized trials and virtual monitoring strategies by sponsors and CRO’s

2. The rising consolidation of site networks and integration of research into care settings

3. Integration with EDC, eConsent, and other technologies

Learn more about why eSource has such transformational power and how eSource will emerge as the backbone of research operations.

NOTE: This session does NOT offer ACRP Contact Hours.

Learning Objectives:
  • The role eSource plays in facilitating virtual monitoring.
  • How technology facilitates consolidation of research site activity.
  • How to prepare your site for a new era of hybrid virtual trials.

Financial Flexibility with Evolving Times - Budget Considerations for 2021

Jan 14, 2021 11:00am ‐ Jan 14, 2021 12:00pm

Identification: COVID01Jan14

Credits: None available.

Examine the coverage analysis and budgeting process, and how it interfaces with the contract negotiations in this interactive session providing tools and tips to implement right away.

Learning Objectives:
  • Recognize how the industry has changed during pandemic.
  • Analyze the financial impact and assess changes necessary to become a profitable research site.
  • Explain the issues as a result of the pandemic in a site setting.

COVID Trials Rapid Study Startup in Under Two Weeks: How Did We Do It?

Jan 14, 2021 12:15pm ‐ Jan 14, 2021 1:15pm

Identification: COVID02Jan14

Credits: None available.

Hear straight from the experts that executed rapid study start-up and study management using a ‘no touch’ protocol while under quarantine, stay at home orders. The panel will share their real-world experience on rapid study deployment and lessons learned in developing and initiating two large randomized clinical trials studying the effects of hydroxychloroquine in outpatients with confirmed COVID-19 in under two weeks.

Learning Objectives:
  • Describe resources for rapid deployment of emergency IRB review, eConsent, and DSMB review.
  • Demonstrate how to direct a high performing team and develop a quality risk assessment.
  • Identify database build requirements and collaboration with RCs, CRAs and Research Nurses.
  • Jeri Burr, RN, Executive Director, University of Utah
  • Nina Pacchia, PhD, CCRC, Program Director, University of Utah
  • Sam Sorenson, BS, CCRC, Project Manager III, University of Utah

techXpo Session: COVID Catch 22 – Don’t Get Burned Out by Dependency on Technology

Jan 14, 2021 1:30pm ‐ Jan 14, 2021 2:30pm

Identification: COVID03Jan14

Credits: None available.

This session is presented by Exostar.

Ready to simplify your technology footprint for 2021? All those accounts/passwords driving you crazy? Join Kenny Kong as he shares how many of your colleagues in the industry are streamlining their technology access and creating a better user experience.

NOTE: This session does NOT offer ACRP Contact Hours.

Learning Objectives:
  • BUSINESS - Learn about options to help deal with technology issues causing stress while working virtually.
  • PERSONAL – Importance of establishing work/life balance. How to set and manage expectations.
  • THE FIX – The need to aggregate technology and simplify site user access.
  • Kenny Kong, Director – Life Sciences & Health IT, Exostar

Working Together for Study Success: Sponsors, Sites, & Technology Companies

May 13, 2021 11:00am ‐ May 13, 2021 12:00pm

Identification: OE01May13

Credits: None available.

“The advance of technology is based on making it fit in so that you don't really even notice it, so it's part of everyday life.” -Bill Gates.

Join senior site, sponsor, and tech provider experts to explore clinical trial technology and how it does and doesn’t “fit in”. Discuss how sites and sponsors are using technology today and over the next few years; when site and sponsor tech can be complimentary and/or in conflict; what competencies are needed for successful adoption and resources available for support; and how we can all work together to improve experience and study outcomes. Leave with an understanding of all three perspectives and ideas for how you can support their own organization’s preparedness.

Learning Objectives:
  • Describe technology used by sites and Sponsors/CROs and recognize when they are complimentary vs. in conflict.
  • Assess your company’s staff competency and preparedness for technology adoption.
  • Devise an action plan to facilitate future success with clinical trial technology.
  • Elisa Cascade, MBA, Chief Product Officer, DrugDev, an IQVIA company
  • Christine Senn, PhD, CCRC, CPI, ACRP-CP, FACRP, CSM, Chief Operations Officer, IACT Health
  • Mohammed Ali, Global Head Digital Development GCO, Boehringer Ingelheim