CPSA Digest 2002

Proceedings -Thursday, October 10, 2002

TuOA1: Plenary

The Economics of Pharmaceutical Innovation: Trends in Costs, Risks and Returns

Premise:
The perspectives of another sponsor, Solvay Pharmaceuticals, are shared in this presentation which focused on strategies for achieving success in working with CROs. Solvay has a small bioanalytical staff and the role of CROs to their development effort is vital; proper communication and monitoring are important to a successful study outcome. The topics discussed in this presentation included: Why Outsource, Obtaining Good Quotes, CRO Selection, Study Initiation, Effective Study Monitoring, Data Delivery and Obtaining Useful Reports.

Discussion
Outsourcing is a necessary function when the availability of in-house staff is limited, study size is larger than present analytical capacity, special requirements exist for the analysis, and for strategic reasons. Expectations between the sponsor and CRO must be shared and understood in order for a successful study to be conducted. Some of the important study parameters to be communicated include:

• Confidentiality Agreement
• Method Requirements (development, validation, transfer)
• Assay Range
• Study Specifics
• Data Delivery Expectations
• Bioanalytical Report Expectations

A pre-study site visit by the sponsor is very important and highly recommended. At this visit, technical capabilities are assessed (both in terms of personnel and the facility), the capabilities for achieving quality are evaluated, compliance with current regulations and guidance documents is assessed, and the upcoming study is discussed. How is a CRO selected? Many factors go into this decision including an evaluation of the fit of CRO strengths to the project goals and various quality and project management issues. Solvay's experience suggests that "cheaper is not always better." Various tasks and activities are recommended at different stages of the process in working with a CRO to meet project goals.

Pre-Study Tasks

• Identify primary contacts at both sites
• Define expectations for progress updates
• Study plan documented in detail In-Study Activities
• Periodic progress reports (establish content and frequency)
• Site visit while study is ongoing to monitor activities
• Interim non-QA'd data transmissions to bioanalytical study monitor
• Inform CRO of any mid-study changes

Data Delivery

• QA'd data is always preferred
• Request to be copied on all data transfers
• Anticipate and relate questions from recipient Bioanalytical Report
• Request a draft for comment
• In-house technical and quality review
• In-house content requirements
• Incorporate final report into in-house electronic database

Lessons Learned
Lessons learned in working with CROs over the years were discussed. One important point is that the technical expertise at the CRO and at the sponsor site is critical; the capabilities and the understanding of the needs and analytical solutions must exist so that data obtained are meaningful and valid. Communication must be timely; when time lapses without any contact, there may be real problems occurring or clarification/-direction may be needed. Any anomalies must be shared and reported, such as sample volumes smaller than expected, samples left unanalyzed (ask "why?"), inconsistent report formatting and/or errors in QA'd data.

In addition to communication between the sponsor and CRO, the communication within the CRO is very important. The CRO project manager must be capable and effective at managing the sponsor's project. Internal resources must be defined and secured, and scheduling needs to be managed daily; timeliness and report deadlines must also be monitored. That project manager represents the sponsor's needs and interests and is the liaison to resulting in a successful study conclusion.

Keys to Success
Overall, arranging for and managing a study between a sponsor and a CRO is an important task that takes much planning, research and time. Some of the keys to success identified by Solvay Pharmaceuticals include:

• Clear points of contact are established at both sites
• Details are well defined prior to study initiation
• Deliverables are clearly understood
• Regular communication occurs between the sponsor and CRO

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