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With a continued focus on technological innovations in clinical research to addressing industry challenges to a new focus on members, we’re happy to bring you the latest ACRO updates. Please forward this email to colleagues and feel free to be in touch with us. Thanks for reading!
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Sharpless and Hargan meet with ACRO Board of Directors
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Acting FDA Commissioner Ned Sharpless (left) and HHS Deputy Secretary Eric Hargan (right) met with the ACRO Board of Directors in September. Both guest speakers shared their views on CROs, real-world evidence and technological innovations in the clinical research industry. For more related to Hargan's comments on health data and technology, click here.
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RBM at SCRS 2019 – Attend the ‘Best Practices’ Workshop for Sites
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 ACRO is looking forward to the 2019 SCRS Site Solutions Summit in sunny Florida! Every year, SCRS is committed to making this “the site’s meeting.” The SCRS Site Solutions Summit is a unique hub where sites, sponsors, CRO executives and regulators come together and share best practices, build their businesses, and develop new partnerships through debates, ideation sessions, workshops and focus groups.
This year, ACRO’s CRO Forum continues its leadership on Risk-Based Monitoring (RBM), with a workshop on Saturday, October 12 at 4:30pm. The breakout session, Risk-based Monitoring: Friend or Foe? will look at current trends surrounding RBM (and RBQM) and the impact on sites. A framework of best practices will be provided to assist sites in maximizing efficiency when planning and executing studies that follow RBM principals. Workshop panelists include:
- Nicole Stansbury, VP, Global Clinical Monitoring, Central Monitoring Services, Syneos Health
- Brian Barnes, Director, Risk Based Monitoring, PPD
- Lisa Moneymaker, VP, Product Management, RBM, Medidata Solutions
- Carrye Nibbelink, Director of Adaptive Trial Management & Monitoring and Innovation, PRA Health Sciences
Please share with your site colleagues and join us! You can register for the SCRS Summit here!
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Addressing Industry Pain Points
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ACRO’s Industry Pain Points Committee is completing its slate of 2019 initiatives and looking at new projects to pursue in 2020.
In completing our 2019 issues, the Trial Master File (TMF) Subteam is working on producing a companion Q&A to the EMA and MHRA TMF guidances, to bring further clarity to issues such as contemporaneousness, completeness, draft files, and inspections. The Sponsor Oversight issue is being handled by a subset of ACRO’s CRO Forum, with a position paper expected to be finalized by the end of October.
The committee is currently gathering information for next year’s efforts and will have a new set of initiatives selected and ready by the end of Q4 2019.
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October Congressional Briefing
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In collaboration with the Congressional Research and Development Caucus, ACRO is hosting a Capitol Hill briefing on Wednesday, October 23, entitled “21st Century Innovation in Clinical Trials.” ACRO panelists will meet with Members of Congress and their staff to discuss the ways in which clinical research and technology companies are continuing to drive clinical trial innovation through advancements such as real-world data and evidence, artificial intelligence and machine learning, and novel clinical trial designs.
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Artificial Intelligence in Clinical Research – A Free Webinar
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ACRO’s Executive Director, Doug Peddicord, joined the editor of Outsourcing Pharma and experts from DIA Global and OWKIN to discuss how AI is impacting clinical research today and how this technology may change the future of drug development. Catch up with this free webinar.
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ACRO welcomes Elyssa Clauson as the new Membership Coordinator. In her role, Elyssa is responsible for gathering information about services and initiatives of each member company, assisting with coordination and outreach for various ACRO committees, and providing support to the ACRO team. By adding this position, ACRO aims to keep staff updated on member activities as the Association champions the shared interests of the industry. Elyssa holds a Bachelor of Science in Public Health from The George Washington University.
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