As biopharmaceutical companies rush to bring new vaccines to patients as fast as possible, consideration needs to be given to the most efficient process for study start-up that allows for collection of measurable data in real-time. With the insights and experience gained in participating in 80+ vaccine studies in the last five years, Parexel’s experts share their insights to initiating the optimal clinical vaccine trial.

This webinar will cover the topics of:

  • How data surveillance improves data quality and integrity
  • Optimal study start-up strategies
  • How to utilize site relationships in key COVID-19 epidemic countries
  • Utilizing a Phase I-unit for vaccine studies
  • Leveraging a pre-configured IRT / CTMS solution

Featured Speakers

Peter G. Genakos, JD

Vice President, Global Study Start-Up

Peter has 30 years of biopharmaceutical industry experience with the first 20 years on the sponsor side at Merck and Sanofi and the last 10 at global, boutique, and specialty services CROs. While he is currently leading Global Study Start Up at Parexel, he previously led all clinical development functions including Biometrics, Clinical and Ancillary Supplies, Clinical Operations, and Drug Safety/Pharmacovigilance across all Therapeutic Areas and phases of development.

Agnieszka Gackowska, M.D.

Global Head, Clinical Feasibility & Site Alliance

Agnieszka has nearly 25 years’ experience in the pharmaceutical industry. She is responsible for leading Parexel’s global team of Site Alliance Managers, building and managing relationships with strategic research institutions. She supports the development of different site management models to decrease work burden on investigators and make new drugs available for patients more quickly. In 2018, Agnieszka also assumed the position of the Global Head of Clinical Feasibility Mangers responsible for site identification to awarded trials.

Nick May

Senior Director Clinical Operations

Nick leads Parexel's Data Driven Monitoring (Risk Based Monitoring) approach. He is responsible for understanding and anticipating strategic, market and operational needs and translating those needs into effective strategies, improved processes and technical solutions across the organization.  Nick has 25+ years’ experience in clinical research, project management and clinical operations, including significant experience in the delivery of remote site monitoring and global central laboratory services on large global/multi-national studies, across many therapeutic areas.

Sylvain Berthelot

Global Head, RTSM and EDC Solutions Consulting

As the Global Head, RTSM and EDC Solutions Consulting, Sylvain is consistently applying innovative solutions to reduce the technology burden imposed on sites, allowing them to focus on what is the most important: patients. The Parexel Informatics RTSM and EDC solutions are consistently enhanced to meet the needs of sites and patients, which allows Sylvain and team to focus on turning complex situations into efficient and reliable solutions.

Register now for this webinar