Sponsors know that clinical trials are one of the most expensive endeavors for their company. Many sponsors would like to manage their trials in-house, but lack the needed infrastructure. Yet, sponsors have reservations outsourcing clinical research due to problems experienced working with CROs. These difficulties include lack of pricing clarity, poor communication, and inconsistent commitment to projects.¹ In our experience, sponsors can better manage these issues by improving the processes they use when selecting CROs.

Sponsors typically select CROs in a competitive bid process. Sponsors issue a request for proposal (RFP) to a number of CROs. The RFP describes the project the winning CRO will perform. In addition, it instructs CROs to provide information the sponsor requires to identify the vendor that best meets its needs.

CROs then bid on the project by preparing a proposal. The sponsor reviews all proposals and awards the contract to one of the bidders.

The winning CRO's proposal, premised on the RFP, establishes the foundation of the project plan. An inadequate RFP leads to inadequate proposals, which leads to an inadequate project plan. This, in turn, leads to budget creep, insufficient resources to complete the project, and the potential collapse of the relationship between sponsor and CRO.²

We have written proposals for CROs bidding on clinical projects valued at more than $10 million. Through this experience, we have seen poor RFPs as well as excellent ones. This article distils our experience and presents the five biggest mistakes sponsors make when preparing RFPs. Readers will learn what these mistakes are and gain insight into how to avoid these pitfalls. These mistakes include:

• Lack of proper preparation
• Omitting vital information
• Not verifying CRO qualifications
• Over reliance on bid grids
• Failure to properly evaluate pricing.

Lack of proper preparation

Many sponsors issue RFPs before they have a sufficient understanding of their outsourcing needs. In some cases, this is okay if the sponsor is using a CRO to help finalize certain details of its clinical plan. However, if too much of the clinical plan is undeveloped, the sponsor gives the CRO power to design a plan they want, not the one the sponsor needs. The plan the CRO wants is the one that will win the contract.

CROs have learnt that, on average, a low price wins contracts. Moreover, they know that many sponsors will choose a proposal with a low price even if the proposed project plan does not reflect their needs. We once raised this issue with a clinical manager at a sponsor when we lost its contract to a lower bidder. To our surprise, the manager agreed with us. She knew she would need "extra" services from the CRO to meet their clinical needs. However, key decision makers at her company focused more on price than on what their actual needs were, or the risks of not having those needs met.

Sponsors allow this to happen when they do not take the time to educate themselves on what their needs are. Thus, CROs will design a bare-bones project plan with a low price. Only once the project starts does the sponsor learn the extent of the services it actually needs, and the project's scope and budget inflate. So, before issuing the RFP, sponsors should have a solid clinical plan.

Perhaps the sponsor will leave some details for the CRO to finalize. But the more the sponsor can tell the CRO, the more it retains the power to ensure the project plan and budget developed by the CRO are realistic. To do this, the sponsor must put in effort before issuing the RFP. It must thoughtfully map out its clinical program. If the company lacks the expertise to do this in-house, it should acquire expert help.