If you fail to plan, you are planning to fail. These words ring true when it comes to study startup (SSU), especially as the clinical trials sector embraces planning as key to boosting study quality. With research showing a continually stagnating timeframe for conducting clinical trials and a trend toward overhauling study performance, quality improvement is moving to center stage.
Planning works by getting it right from the beginning—prior to study activation—requiring sponsors and contract research organizations (CROs) to identify what is needed up front to reduce risk.
It’s difficult to understand why there is so much variation and why there are so many inefficiencies and delays in study startup. It’s a bottleneck at the outset of a study with cycle times that haven’t budged in over two decades.
So, what attributes make some organizations more consistent that others in adherence to timelines and budgets?
In this webinar, we will explore:
- The correlation between consistency and speed advantage of organizations in their end-to-end processes
- Attributes of consistent organizations: percentage of site non-activations, frequency of engaging new sites, size of organization, technology investment
- How workflow-based SSU tools, proactive planning, process optimization and quality improvements can 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
Mary Jo Lamberti,
Senior Research Fellow - Tufts CSDD
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.
Charles Curran,
Senior Director, Product Management - goBalto
Charles is a seasoned product management professional with over 10 years of experience in the healthcare industry. Prior to goBalto, Charles was in charge of product management at Change Healthcare. He holds a patent in patient identity and has two additional patents currently pending in the healthcare IT space.
Charles was a contributing member to the Direct Trust project helping to create a new standard for healthcare communication in the US, and has testified to the HHS on challenges of healthcare interoperability.
- The correlation between consistency and speed advantage of organizations in their end-to-end processes
- Attributes of consistent organizations: percentage of site non-activations, frequency of engaging new sites, size of organization, technology investment
- How workflow-based SSU tools, proactive planning, process optimization and quality improvements can improve operational performance and help companies remain on-budget and on-time
- Clinical Operations
- Regulatory Compliance
- Outsourcing
- Contracts
- Project Management
- Excellence/Innovation
- Regulatory Innovation
- Regulatory Affairs
- Operational Oversight
- Clinical Reporting
