Outside of a well-written protocol, no other item is as critical to the success of an outsourced clinical trial as choosing the right contract research organization (CRO) to manage it. All too often, trial sponsors express strong dissatisfaction with their CRO’s performance — yet many of the complaints could have been avoided with some simple upfront planning. Therefore, it is important to know the common mistakes that occur during CRO selection and how to deal with them.
Join this webinar with clinical outsourcing experts to discover how to successfully identify and address common errors and overlooked items in the CRO selection process, including:
- How to ensure that the CRO is the best match for the sponsor’s study objectives, timelines and budget — while delivering the highest-quality data
- Why cultural fit with the sponsor’s organization and project team is just as important as the CRO’s functional capabilities
- How to craft a bid request to avoid key project team substitutions, unnecessary costs or mid-study change-orders
- How to compare CRO budgets to ensure a true apples-to-apples comparison, even when they have different specifications, line items and levels of detail
- How to ensure the sponsor has full visibility into the study at all times — avoiding potential problems and fulfilling oversight responsibilities
- Why it’s critical to assess a CRO’s proven problem-solving abilities and backup plans — since all clinical trials run into unforeseen challenges at some point
- How to ensure the CRO’s clinical research associates (CRAs) interact well with the study site person and properly represent the sponsor
The featured speaker will also help with “reading past the sales pitch,” to equip the sponsor with the hard questions needed to uncover the “real” CRO. As just one example, the common statement “We offer all of the services you require” does not mean that their services are all the same quality — and in fact key services are often subcontracted to third-party vendors, adding complexity and risk to a study. This webinar will not only save a sponsor time and money, but also the trouble of having to deal with frustrating results.
Gerald L. Klein, MD, Principal, MedSurgPI
Dr. Klein has been the founder of an SMO, CRO, Medical Writing Company, Analytic Lab, GI Biotherapeutics company and a physician consulting company. During his career, he has also served as a CEO, CMO, SVP (Quintiles/IQVIA), VP of Clinical Research and Medical Affairs, and member of the board of directors of several companies. Dr. Klein has been a Clinical Professor of Medicine and Pediatrics (Division of Basic and Applied Immunology) at the University of California, Irvine. Dr. Klein currently serves as a Principal of MedSurgPI, a physician consulting company. He is an associate editor, editorial board member and reviewer for several medical journals. Dr. Klein has published numerous peer reviewed journals, white papers, medical blogs, a textbook chapter and a book on bronchial asthma.
Who Should Attend?
- CMO (Chief Medical Officer)
- COO (Chief Operating Officer)
- CIO (Chief Information Officer)
- Executive Leadership:
- S/VP of R&D
- S/VP of Clinical Development
- Therapeutic Area heads (e.g., oncology, neuro)
- VP of Clinical Operations
- VP of Clinical Data Management
- Study Management:
- Directors/Managers of Clinical Operations
What You Will Learn
- Examine the potential operational and budgetary pitfalls when choosing CROs and how to avoid them
- Compile several lessons learned from decades of CRO procurement experience in order to make sure that an initial procurecament strategy is set up to make the entire duration of the study successful
Prevail is a pioneering life sciences software company with a unique combination of clinical expertise and engineering prowess, delivered through a best-in-class, modular eClinical ecosystem with sophisticated analytics and visualizations and supported by Prevail domain experts. Our innovative and patented technology quickly and easily integrates, normalizes, reconciles, and presents aggregated data, analysis, trends, and metrics encompassing all study-related data sources through a single interface — making clinical development faster and easier, while reducing trial risk. With Prevail, trial sponsors and CROs can obtain unmatched, real-time answers to virtually any clinical, operational, and financial question regarding a study or program.