Does Efficiency Depend on Organizational Structure of ClinOps Teams?

Empowering Collaboration and Communication

A critical question facing many sponsors and contract research organizations (CROs) is whether another system to support study startup (SSU) is really needed. It’s a fair question in the clinical world where the urgent need for better execution of clinical trials has led to a proliferation of technologies, namely the clinical trial management system (CTMS); the electronic trial master file (eTMF); electronic data capture (EDC); and others. Each of these solutions focuses on specific pieces of the clinical trial continuum, yet, they overlook aspects unique to SSU, a multifaceted process that continues to stumble and stall clinical trial timelines.

SSU is very complex, and a recognized bottleneck whose functions are performed by multiple people in multiple locations at the sponsor, CRO, and site levels, all of whom need to communicate and share data. To make this happen, a dedicated SSU system integrated with the other clinical trial technologies is essential, but what about the organizational structure of clinical operations teams?

Do centralized groups outperform non-dedicated groups?

In this webinar, we will explore:

  • Comparison of cycle times by dedicated vs. non-dedicated functional group
  • Repeat Site vs. New Site cycle times for Centralized vs. Localized (non-dedicated) Functions
  • Does having a Centralized Function impact the percentage of sites not activated?
  • Impact of Study Startup management technology, perceived adequacy and satisfaction between centralized vs. localized functions
  • To centralize functions or not? Opportunities for enhancing Study Startup between Centralized and decentralized functions
  • How technology can aid in the Study Startup continuum irrespective of study team location to improve operational performance and help companies remain on-budget and on-time.

This webinar is applicable to:

  • Sponsor and CRO roles responsible for site identification, feasibility assessment, selection and activation
  • Sponsor and CRO roles responsible for collecting and evaluating trial metrics

Presenters:

Mary Jo Lamberti
Mary Jo Lamberti manages multi-sponsored and grant funded research projects at the Tufts Center for the Study of Drug Development (CSDD) at Tufts University School of Medicine. She has extensive experience conducting research on biopharmaceutical industry practices and trends affecting contract research organizations and investigative sites. She has been a speaker at industry conferences and has published articles in trade and peer-reviewed journals. Prior to joining Tufts, Dr. Lamberti was director of market research at CenterWatch. She has also worked on federally funded research studies in science education reform and has taught undergraduate courses at Boston University. She holds a B.A. from Wellesley College and a Ph.D. in psychology from Boston University.
MARY JO LAMBERTI
Senior Research Fellow
Tufts CSDD
Rob has been a computer scientist and programmer for over 30 years in the scientific programming, e-commerce, biotech, and health care industries. He implemented study startup and CTMS functionality at 9 bay area biotech companies, and invented a method that allows medical and biotech organizations to use cloud-based analytics to monitor patient data. He holds a BS in Computer Engineering from Sacramento State University and a PhD in Biological and Biomedical Clinical Informatics from UCSF.
ROB WYNDEN
VP Technology & Engineering
goBalto
Rob Wynden

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