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Outsourcing-CRO Selection and Management - PharmaFacts
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Outsourcing-CRO Selection and Management

Access to intellectual capability and options for getting your studies done is a rapidly expanding resource from the big CROs to the small boutique shops with highly specialized skill sets, technologies and models to the start-ups in the CRO world that are eager to get your business at a much lower cost - but who are in the process of getting GLP certified...

CRO Selection

With so much to choose from and so many factors to consider it is hard to know how to pick the best fit for your product, your timeline and your budget.  It may be that getting through to the business development  folks is a much tougher road that you would expect - that can happen and not just with the small companies - suprising but true - you may have already discovered!  And if the business people are all over you like a cheap suit, promising you the earth, you wonder whether you can really believe them and what guarantees are there?  And anyway, simply having a money back type of guarantee is not going to help you recover the lost time if the study has to be repeated, and worse, having to explain that data anyway can be a real headache...

This is an area in which we really think we know what to consider, what to look for and what questions to ask.  We can support you with prequalifying audits from which you then can weigh your options.  Since we know the players and also invest in maintaining a proprietary database of CROs and a network through which we learn about how much what is promised holds up against what is delivered we think we have a pretty good finger on the pulse of things.

Study Design, Protocols, On-site Monitoring and Reports

Once you have made your choice, then there is the planning.  Investment in this process can truly save you from a multitude of sins.  If you know it is important to you, make sure it is in the protocol, there in black and white.  That includes your interim delivery dates, data management and report expectations.  There is a very long list of points to consider in this process.  We may be particular about this but, in the long run, we think our very careful attention to these details will provide savings for you in a myriad of ways.  We also believe that on site monitoring is critical.  As they say, a picture is worth a thousand words, and establishing a relationship with the personnel makes a world of a difference, definately making for a smoother ride.