Friday, February 19, 2010

Strategic Partnerships in Clinical Trials and Clinical Submissions

Often pharma companies are faced with a huge pipeline of drugs, devices and technologies to develop after M&A. Often after or during a M&A, and as a result of the M&A, there is not enough in-house employees or employees with the specific expertise required to develop and conduct clinical trials and/or prepare and submit a clinical submission to FDA and/or regulatory agencies worldwide. There is no shortage of CROs who participate in resourcing outsourcing needs or even "partner" with the pharma company. These strategic partnership agreements between pharma and the CRO are often created and do benefit both the pharma sponsor and the incoming CRO. The selection of a CRO and more importantly a CRO strategic partner is no an easy process. In fact, if performed correctly, the process of selection very much resembles an audit and takes much time and effort. However, the time and effort spent on selecting a fit for your clinical trial and clinical submission is critical and unmeasurable in value. To ensure a fit with pharma and the CRO is terms of vision, one needs to look closely at CRO metrics such as "pace and intensity, quality and met timelines". Look at the track record of "success" in the particular therapeutic field of development and submission for starters.

Recently, I read a brief summary describing the monetary consequences of not choosing the appropriate CRO or CRO partner. Internal resource burden of not outsourcing efficiently can result in 50% more FTEs. Having to repeat a Phase 2 clinical trial due to erroneous, incomplete, data can amount to $10-$20M. Selecting the wrong clinical partner for your clinical Phase 3 trial will cost the pharma partner $5-$10M. Loss of valuable time to market due to clinical trial delays can result in an extra unnecessary expenditure of $10-$50M. Therefore, selecting the the best partner for your clinical trial and clinical submission is critical and worth due diligence, audit and investigation.

More to come pertaining to the selection of a clinical trial and clinical submission partner.

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