We all know how to run research, so why do the processes change so drastically between countries and regions? Nowhere is this more prevalent than when using technology; the processes, the procedures, and the regulatory challenges often feel like the wild west, so why is this? Is it an agency issue, or is it a wider industry issue?

Throughout this session, you will acquire a more comprehensive understanding of the ongoing debate between "Regulation versus Implementation." Is it a matter of regulations or a cultural issue specific to a region or country? Being able to grasp these subtle differences is crucial to putting research technology into context as your studies progress and new locations are added.

CEU: 1.00 ACRP

Speaker:

Sara Saunders, Manager, Regulatory Affairs, Florence Healthcare

Year after year, too many trials are run out of the same few sites, limiting patient access and harming the goals for levels of diversity, equity, and inclusion that will truly benefit the clinical research enterprise and public at large. In this session, Liz will share first-hand insights into how she’s seen sites reimagine their approach to successfully spur greater interest with more sponsors by focusing on building community relationships based on trust and connecting with diverse patient populations.

CEU: 1.00 ACRP

Speaker:

Liz Beatty, Co-founder and Chief Strategy Officer, Inato

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For sites that have embraced decentralized clinical trials (DCTs), the road has often been bumpy, but even those who haven’t cannot avoid them forever. This session provides real-world strategies on how sites can implement the technologies necessary for providing increased flexibility in collecting, monitoring, and reporting clinical trial data when conducting DCTs that will satisfy regulatory expectations.

CEU: 1.00 ACRP

Speakers:

• Heather Bowman, BSN, RN, ACRP-CP, Regional Site Manager, The Spine Network

• Marcus Stone, PhD, Principal, The Spine Network

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With the U.S. Food and Drug Administration making it clear in recent guidance that electronic regulatory records in site-owned systems are definitely subject to CFR 21 Part 11 in the Code of Federal Regulations, this session focuses on how sites need to understand the requirements and develop strategies for compliance.

CEU: 1.00 ACRP

Speaker:

Stuart Cotter, VP, Product Strategy, Advarra

Related Blog Content:

Understanding a Site’s Responsibilities for Essential Documents in Electronic Systems

While eRegulatory (eInvestigator Site File) systems favored by study sponsors offer many advantages to sites, their adoption and use may place burdens on site personnel that can be alleviated with careful planning and collaboration between partners. Speakers in this session will share specific use cases where the use of eRegulatory has made a positive impact on clinical trials, as well as overall metrics on site adoption, user feedback from site and sponsor roles, and lessons learned and future opportunities for both study coordinators and monitors.

CEU: 1.00 ACRP

Speakers:

• Dan Knight, Associate Director of Clinical Research, Merck

• Kayla Perry, Clinical Research Associate, Merck

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All clinical research professionals can benefit from applying the appropriate technologies to their project management and communications needs. This session offers advice on taking control of your work life by learning the right tools and best practices to get better organized, improve your quality and recall, and become a master communicator.

CEU: 1.00 ACRP

Speaker:

Suzanne Kincaid, CCRA, ACRP-PM, FACRP , Consultant, Owner, Responsibility Research

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Connect with your colleagues and 100+ leading-edge organizations and suppliers helping you get better results in clinical research.

Relax and unwind with a beverage and light hors d'oeuvres at our reception beginning at 5:00pm.

With retail pharmacy chains such as Walgreens, Walmart, and Kroger ramping up their clinical trials activities from referring patients to acting as investigative sites, this session will explore attitudes of site personnel, biopharmaceutical executives, and patients concerning the barriers and opportunities to pharmacy involvement on this new horizon for decentralized clinical research.

CEU: 1.00 ACRP

Speakers:

• Emily Botto, Senior Research Analyst, Tufts Center for the Study of Drug Development

• Bree Burks, RN, MSN, Vice President of Strategy, Site Solutions, Veeva Systems

• Nancy Sacco, PhD, VP Head of Clinical and Site Development Operations

  SiteBridge Research Inc

• Adam Samson, MS, PMP, CCRA, CCRC, CCDM, Head of Clinical Delivery Operations, RWE Clinical Trials, Walgreens

• Sara Edwards, Senior Director, Decentralized Design & Delivery Integration, Eli Lilly and Company (Moderator)

Are you wondering if the correct site was selected at Validation? Are you unsure if the selected site will be a good representation of your company? Look no further! "Site Validation/Qualification - Picking the right sites" will offer suggestions to ensure that the correct sites have been chosen. This session will teach you how to select good sites, how to better perform site facility assessments, and understand the overall importance of the validation visit.

CEU: 1.00 ACRP

Speakers:

• Kristi Pinkston, BS, RN, MABC, Senior Clinical Research Associate, Merck

• Carmen Thornton, RN, BSN, Senior Clinical Research Associate, Merck

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