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Selecting the Right Vendor for Phase I Clinical Trials: Preferred Provider List or Bidding Process?

But how does a drug company choose the right CRO or third party to run a Phase I trial? Well, there are generally two ways to select a vendor:Phase I clinical trials are supposed to be the quickest, easiest trials with the simplest question in mind: will the drug harm the patient?  No? Good, then you may proceed. However, sometimes the trials are not as straightforward as all that – there can be problems in recruiting, sites can drop out, etc. For many companies, a good way to expedite Phase I trials – and save a little money – is to use contract research organizations (CROs) to administer the trial. In fact, surveyed drug companies outsource 70% of Phase I trial costs.

  1. Choose a CRO from the Company’s Preferred Provider List: When a company undertakes Phase I vendor selection, it can simply go to its list of preferred providers – the vendors that the company has worked and built strong relationships with. The clear advantage to using CROs from a preferred provider list is that the company is already familiar, and has presumably built trust, with the vendor and its protocols. Furthermore, the company will save time when writing contracts because it can use the same contract template for all of their deals. However, a potential drawback of using preferred vendors is that the CRO may not be the best fit for a particular Phase I clinical trial. To sidestep this issue, companies may choose to have preferred vendors handle only certain aspects of their clinical trials. For instance, one interviewed company has one preferred third party handle the electronic data capture (EDC) for all of its clinical trials.
  2. Begin a Bidding Process for Vendors to Compete for the Company’s Business: For this process, most surveyed companies send requests for proposal (RFPs) to three to five CROs. Each interested CRO creates a proposal, and the vendors essentially compete with each other to get the company’s business.  As a result, this process helps drug companies find the best CRO for its Phase I trial – and at the best price.  Nevertheless, small companies that need specific or very experienced labs may risk losing the CRO should a larger company offer the vendor a more lucrative opportunity.  Moreover, it may take about 2.5 months from RFP to signed contract whereas preferred provider lists offer a quicker process.

Of course, companies can combine these two methods and send RFPs to both unfamiliar CROs and those on their preferred provider list. There is no one-size-fits-all solution for picking a vendor.  But with these options, a company can choose the CRO best-suited for its Phase I trial.

Natalie DeMasi
Research Team Leader
Trial Master File Benchmarking Data
Trial Master File Benchmarking Data
Early-Stage Product Development
Early-Stage Product Development
adaptive design clinical trials
Adaptive Design Clinical Trials

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