How do you get a potential contract service providerto give you a true list of its

acknowledged capabilities prior to an audit?

For anyone on the sponsor (pharmaceutical company) side of the equation, the bottom line of what one is looking for from a potential contract service provider is a priori ‘Proven Validation of Robust-Promise’ (PVRP) of potential success for any outsourcing project. They want to see the same transparency, quality and speed at better costs than if they were to executing the project internally.

We oftentimes get to see so much advertising with ‘glossy’ photos of the equipment, buildings, staff and other descriptions of what the service provider can do for us. At times, when you drill down to specific details, you get to see the real picture. I have noticed a tendency among providers to say, “We do it all under one roof.” However, after further teleconferences, you find out that there are many gaps in what is being presented to you. When you question the service provider about these lacunae, at times you hear that they provide these services through “another partner” (that is, a sub-contractor).

Wouldn’t it be nice to have a picture of reality presented upfront rather than the having to find out via thorough questioning – almost a hostile interrogation – of the service provider? I would love to get a “peer review” from other sponsor companies before venturing to work with a service provider. You may never get to hear or read such “reviews” published in an open forum; as I’ve mentioned in a previous column, a brief private conversation with a peer during a conference break may help provide that validation one is always looking for.

Prior to commissioning an audit – either a QA audit or just an informal one – before commissioning of project work, it always helps if the service provider provides the following: references and a list of equipment/instrumentation that has gone through rigor of validation and reviews. Also, it helpsto get a ‘virtual tour’ of the facilities posted through a website. It’s a bonus if the service provider provides a list oftechnologies/special capabilities that it provides to its clients, for use, (exclusive or non-exclusive) licensing or for the sponsor’s benefit.

For a contract manufacturing service provider, it also helps, for example, if packaging capabilities are in house, along with capability to do site stability programs. In reality, it makes everyone’s job easier if everything is provided upfront. If any FDA audits have been performed, the audit reports are quite useful. If there are any past regulatory issues, it is best if the service provider brings them to the attention of the sponsor company. It’s always good to know that the service provider has come out clean with all its regulatory agency audits in addition to other sponsor audits.

The sponsor’s representative is always looking for that ‘Robustness Promise’ that only comes from honest presentation of the provider’s credibility, capacity, scalability and capabilities at reasonable costs. It is always good to have a clear dialogue and application of science and technology to fulfill the sponsor’s needs. Ideally, I have found that having the appropriate people interacting with their counterparts from either side – and providing “undivided attention” to each other’s needs – always works the best.

Once the project gets started and continues, I also think that portraying an ongoing “dashboard” of activities, creating some kind of feedback mechanism – both ways – and constructing and maintaining a set of performance metrics always seem to provide priceless tools for continuous improvement of the sponsor-provider bond, as well as a blueprint for an ultimate successful relationship!

Makarand (Mak) Jawadekar most recently served as Director, Portfolio Management and Performance at Pfizer Global R&D,until February 2010, when he opted for an early retirement after28 years at Pfizer Inc. He currently serves on several companies’ advisory boards and also consults with bio/pharmaceutical companies for global outreach in emerging market regions. He can be reached at [email protected].