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A Trio of Talent: Scientific Collaboration Inside a CRO

Time

Wed, Jun 26 11:45AM
W 06

Title

A Trio of Talent: Scientific Collaboration Inside a CRO

Abstract Summary

We established a matrix of dedicated and enthusiastic peri- and post-approval study expertise known as the BEAM (Biostatistics, Epidemiology, and Medical Writing) Team. To accomplish this, we drafted a team charter, vetted the charter with executive leadership, identified ‘late stage talent’ (with a high tolerance for uncertainty) around the globe, created distribution lists, and held an early morning WebEx kick-off meeting with all of the volunteers and conscripted individuals in June 2012. The goal was and is to have the BEAM Team's biostatisticians, statistical programmers, epidemiologists and medical writers come together at the earliest opportunity to map out the most efficient and effective approach to meeting a study’s deliverables. The nature of those deliverables (e.g., for publication only versus submission to a health authority) and the study’s design (e.g., RCT versus a natural history study) determine the’ RACI’ (responsible, accountable, consulted, or informed) table for each deliverable within the study. Development and production of the protocol, CRF(s), patient survey(s), SAP, TLFs, study report and abstract(s)/manuscript(s) (as applicable) involve a thoughtfully orchestrated exchange of materials between team members. Each team member is responsible for drafting, reviewing, or finalizing each deliverable as determined by the RACI table. The primary objective of this initiative is to produce study deliverables on time, within budget, and to the complete satisfaction of our clients. The secondary objective is an increased level of trust and collaboration among team members who might otherwise compete for resources at the design stage and throughout the course of the study. We are in the process of - as a first indicator of efficiency - comparing study bids before and after the institution of the Team in order to assess whether or not duplication of effort and total cost from the three service areas combined has decreased. Early indications of effectiveness will be captured in a survey of BEAM -contributors, -bidders, and -supported clients to assess levels of trust, collaboration, and satisfaction, respectively. We will also examine the RACI table proposed for each study to assess whether or not it exists and is in use by the Team.

Poster Presenter

Margaret S. Richards
PhD, MPH,
Executive Director, Epidemiology and Health Outcomes,
PPD
United States

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