Mergers and acquisitions among CROs create a great deal of uncertainty for sponsors, as this consolidation can impact their current and future clinical trials. Evaluating CROs can help alleviate some anxiety, as it allows the sponsor and CRO to identify and address any issues that might be affecting trial quality. However, for this exercise to be useful, it is necessary to be transparent, ask the right questions and know what the answers should be.
Naturally, the “right” questions will vary, depending on a variety of factors. It makes sense to start by examining areas where problems are known to exist, making sure to drill down to specific categories. Look at issues across:
- Therapeutic areas
- Geographical regions
Principal Investigators and study coordinators can provide valuable insights into what is working well and what could be more efficient. By comparing these site-level responses with a normative database, it is possible to determine areas of concern — and to do so in measurable terms. The sponsor can use this information to address any issues identified in the process. The data also provides a new baseline against which to gauge any corrective measures implemented.
All of this is only achievable when there is transparency and openness. Working on the sponsor’s behalf, an independent third party enables site personnel to provide honest, transparent feedback that increases the utility and value of information obtained from the sites.
To quote Clinical Leader editor Ed Miseta, “Consolidation in the life sciences industry is a fact of life.” The mergers are not likely to end soon. Clinical SCORE has a tool to help sponsors and CROs work better together and keep programs on track in a changing landscape. If you’d like to know more about Attune, call Blaine Cloud at (877) 334-0100, ext. 1005.