Clinical Development in the COVID-19 Era: Trial Continuity and Restarting Quickly, Safely and Successfully

Life Sciences, Clinical Trials, Pharmaceutical, Patient Recruitment & Retention,
  • Friday, April 24, 2020

COVID-19 has challenged our industry to quickly rethink and adapt long-standing methods of conducting clinical trials. Important questions have been raised about access to sites and site resourcing, while companies continue to prioritize patient safety, maintain data integrity and reduce the burden on our health care system — all while pivoting to a new virtual trial environment. At Syneos Health, we have developed a staged approach that can help biopharmaceutical companies of all sizes mitigate the effects of COVID-19 on trials. 

Please join us for a free webinar where our featured experts will discuss key steps for the short-term and mid-term continuity of ongoing trials, as well as strategies to consider when restarting trials.

Speakers

Tim Raducha-Grace, Syneos Health

Tim Raducha-Grace, SVP, Global Client Solutions Partnership Office, Syneos Health

Tim Raducha-Grace leads the Syneos Health Global Client Solutions Partnership Office, including structuring and delivering our partnerships. The Partnership Office also aims to drive innovation and share best practices with our partners.

Raducha-Grace previously led clinical partnerships for multiple technology driven health care organizations. He has deep experience with public health preparedness, both as a top aide in the US Senate to the Chairwomen of the Homeland Security Committee and leading a major academic center in public health preparedness research. 

Message Presenter
Allison Lapchak Rutkowski, Syneos Health

Allison Lapchak Rutkowski, MS, MBA, SVP, Operations Management, Clinical Development – General Medicine, Syneos Health

Allison Rutkowski has over fifteen years of experience in clinical research including trial specific roles as a CRA, Project Manager and Project Director, in addition to roles of increasing seniority in operations management within Clinical Development Operations Management from Director to Senior VP.  Within Operations Management, Rutkowski is responsible for performance strategy and business planning; analytics and reporting; systems compliance; operational delivery and quality; project management standards and best practice.

Message Presenter
Sheena Dempsey, Syneos Health

Sheena Dempsey, SVP, Global Client Solutions, Syneos Health

Sheena Dempsey is an accomplished executive with over 25 years of general management expertise as well as sales and operations experience, providing professional services to Fortune 500 companies in the life sciences and other verticals. She is a key member of the Syneos Health COVID-19 Task Force and an executive liaison with global clients. Dempsey previously led the delivery of clinical solutions to top pharma and has many years of executive experience building best practices internationally.

Message Presenter
Alastair Macdonald, Syneos Health

Alastair Macdonald, SVP, Real World and Late Phase, Syneos Health

Alastair Macdonald has nearly 30 years of experience in the biopharmaceutical development sector that he brings to bear providing insight into the generation of Real World Evidence and peri-approval requirements, and working to help customers maximize value. Prior to Syneos Health, he was the Global Delivery Director for Medical Evidence and Observational Research at AstraZeneca with responsibility for the generation of evidence, in both pre and post approval drugs, required to support core clinical development programs and prepare for reimbursement. Other roles at AstraZeneca included Clinical Leader within the UK local affiliate, moving subsequently to the role of European Study Program Director for Oncology and Infection, with accountability for the regional delivery of pivotal Phase I-III oncology programs before undertaking his Real World Evidence Delivery Director position within Global Medical Affairs.

Message Presenter

Who Should Attend?

Director and Senior level professionals from biopharmaceutical companies working within:

  • Medical & Scientific Affairs
  • Clinical Operations
  • Clinical Monitoring
  • R&D
  • Regulatory
  • Patient Recruitment & Retention
  • Commercial Launch Strategy
  • Pricing & Market Access
  • Life-cycle Planning
  • New Product Planning
  • Portfolio Planning
  • Outsourcing/Procurement

What You Will Learn

  • Key strategies for continuity in the short term when patients can’t get to sites, sites can’t reach patients and site resources are stretched to the limit
  • Specific examples of site support needed to keep trials on track and new opportunities for enhanced patient engagement
  • Ways to prepare for recovery following COVID-19 by developing a re-start playbook now

Xtalks Partner

Syneos Health

Syneos Health (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together approximately 24,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.

To learn more about how we are shortening the distance from lab to life®, visit syneoshealth.com.

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