Full service or specialized? Full service or specialized?
For many looking to hire a CRO, the answer is obvious.
The decision is difficult in part because it touches upon various crucial points of a clinical trial sponsor's strategy: top-notch knowledge and expertise, timely delivery, simple responses to unforseeable events. Your business and development strategy should ultimately affect your decision-making.
Here are a few things you might consider to avoid making a decision that is wrong for you.
1) Do you know where to place your bets?
How important is a particular service to your overall success? Many sponsors understand that messy data or sloppy biometrics may have negative effects on trial submission, but it is often difficult to quantify these consequences. However, even if you aren't positioned to make such precise analyses, you probably still have some insight into what your trial needs. If you have a regulatory deadline, for example, you will need a CRO which can live up to the promise of delivery on time. If statistical analyses is crucial to your success, there is no need to hedge your bets with a less than optimal team of statisticians.
The fact is you do know where you need to place your bets, so why not seek out expertise as required?
2) How much integration can you expect?
In some ways, it is not so much that you need one point of contact from a full-service CRO, but a delivery structure where several project arms are integrated so that you have a team ready to respond to a variety of unforeseen challenges. Unfortunately, the level of integration within one full service CRO or between several specialized CROs varies greatly from company to company. There are specialized CROs where project teams and project managers have worked with each other and with their partners for so long that they manage a seamless operation. There are also full-service CROs where each person is responsible for an all-too-small slice of the project such that only one or two people (if any) are positioned to answer the big picture questions.
Regardless of whether you go full-service or specialized, be sure to ask questions about approaches to project management, integrated reporting capacities, cooperative schemes on deliverables, and other operational efficiencies. There is too much variability to make any assumptions.
3) What is the real trade-off?
As you evaluate specialized CROs determine if there are any special offerings they provide in exchange for their specialized service. For example, here at Cytel, we take pride in the fact that our data base experts can provide the option of a three day service for building databases. Other specialized CROs often provide such non-standard service because they are equipped to leverage their expertise in non-traditional ways.
Demand to know what you will receive when you bet on expertise. A good specialized CRO will be more than happy to provide a long list of answers.
Related Items of Interest
[1] How to Use Outsourcing to Reduce Clinical Development Risk
[2] Regulation and Reproducibility: Can You Reproduce Your Clinical Trial Results?
[3] Data Management and Biostatistics III: Statistical Innovation in Clinical Data Management
[4] 7 Reasons to Add a Statistical Consultant to Your Team
