Vaccine Studies – Operationalize before you Finalize

Clinical Trials, Life Sciences,
  • December 11, 2015

In many pharmaceutical and CRO companies, site planning is the lynchpin for starting the operational activities for a clinical studies, especially in vaccine studies. In many cases that final protocol coincides with the crucial activities, such as choosing a CRO partner and other vendors, CRF development, site feasibility, etc. Involving the operations team as early as possible in vaccine studies is critical due to the amount of pressure on the clinical teams to reach first patient in as quickly as possible.

This webinar will explore the following areas of early preparation in vaccine studies:

  • Important operational questions to ask before finalizing the protocol
  • Incorporating feedback from an experienced site
  • Rethinking how/when the operations team and sites are trained
  • Site planning for optimal enrollment

Speakers

Lynlee Burton, Director of Project Delivery, Vaccines, PRA Health Sciences

Ms Burton provides operational oversight for PRA’s vaccine studies, ensuring each study is adequately resourced and project deliverables meet or exceed our clients’ expectations. Ms Burton gained her in-depth knowledge of vaccine studies over her 20 years of experience in the clinical research industry, including 15 years in project management. Ms Burton managed vaccine studies for 3 of the top global vaccine companies for 9 years, specializing in large, global, pediatric vaccine trials that included influenza, hepatitis B, and hexavalent vaccines. Her global trial experience includes North and South America, Asia Pacific, and Europe. She acquired first-hand knowledge of Europe’s clinical trial practices during her 3 year tenure conducting vaccine trials from the UK. With industry awards for excellence in clinical research and her depth of knowledge of both adult and pediatric vaccine trials, Ms Burton is a vital asset to PRA’s vaccine portfolio.

Jeff Rosen, Medical Director and Founder, Clinical Research of South Florida (CRSF)

Jeffrey B. Rosen, MD, board-certified family physician, Medical Director, and founder of Clinical Research of South Florida (CRSF), has more than 30 years’ experience in clinical research. In his research career, Dr Rosen has conducted over 650 clinical trials in multiple therapeutic areas. In addition to being an extremely experienced investigator, he is a founding member of the Alliance for Multispecialty Research and speaker for several Pharmaceutical companies, especially for vaccine programs.

CRSF’s principals and associates have conducted clinical research in Miami since 1975, earning a reputation for excellence, quality, and consistency. CRSF is the oldest independent clinical research center in Miami. CRSF’s longevity can be attributed to its 2 primary goals: providing ethical, safe, cutting-edge medical care for its volunteers and high-quality, clean data to its sponsors with strict adherence to good clinical practice (GCP) guidelines. CRSF is affiliated with a family practice medical center and associates with other medical practices in the Miami area. CRSF’s investigators are board certified in their therapeutic specialties, with colleagues and patients frequently relying on their medical expertise. Building strong relationships with its patients and associated medical practices aids CRSF in successful recruitment, compliance, and retention in its clinical research studies.

In addition to Dr Jeffrey Rosen, CRSF has 4 sub-investigators located on-site, and they are always available for research purposes. CRSF’s ability to rapidly recruit appropriate patients and maintain high retention rates allows CRSF to produce high-quality study results in a timely manner, earning CRSF a sterling reputation as one of the nation’s leading independent clinical research facilities.

Vaccine research has always been an integral part of CRSF’s focus. Since its opening in 1975, CRSF has performed 38 vaccine trials, enrolling an aggregate of 2,665 patients. Because of its success in the vaccines arena, CRSF is frequently awarded additional subject enrollment goals by study sponsors. CRSF has conducted vaccine trials in influenza, HPV, herpes zoster, Ebola, candidiasis, and other indications.

Who Should Attend?

Executives and managers in pharma and biotech in:

  • Strategic Drug Development
  • Clinical Operations
  • Outsourcing and Procurement
  • Clinical Trial Planning and Optimization
  • Patient Recruitment and Retention

Xtalks Partners

PRA Health Sciences

At PRA Health Sciences, providing innovative solutions for our clients is what we do. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop life-saving and life- improving drugs. We also understand the unique characteristics and challenges of vaccine development. Our recruitment and retention expertise to accommodate rapid enrollment, combined with the right systems to make compliance easier, ultimately empower us to deliver clean and accurate data. But it goes further than that – it’s our ability to execute and deliver on these key components, that sets us apart. Through our experience, we’ve mastered the art of the efficient vaccine study.

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