In the world of clinical trials, having a refined request for proposal (RFP) process is essential. Clinical trials are lengthy and costly endeavors for sponsors. Without streamlined approaches, what is already a cumbersome task becomes incredibly unwieldy. Furthermore, a poorly defined RFP process can lead to delays, budget issues, and more.
Fortunately, optimizing the RFP process is simple. Here’s what you need to know.
What Is an RFP?
An RFP is a formal document that Sponsors provide to vendors, outlining project requirements for the work the Sponsor plans to outsource. The vendors are typically contract research organizations (CROs), while the sponsors are the pharmaceutical companies.
In many ways, an RFP serves as an invitation, encouraging CROs who feel confident they can meet the requirements to toss their hats in the proverbial ring and potentially pick up the contract. Additionally, the RFP gives the CROs a functional framework of what is expected for the project.
Along with allowing CROs to create proposals that address the critical needs of the Sponsor for the project as described, it ensures they understand what is involved. This increases the odds that responding CROs can genuinely meet the needs of the requesting Sponsor, as the requirements are known quantities from the beginning.
What RFPs Should Include
RFPs should include specific information, ensuring that responding CROs have critical details that will lead to comprehensive and accurate proposals. Sponsors should a thorough review of the company’s background as well as an in-depth look at the compound in question.
An RFP must also include a project description and a study synopsis. Including the project assumptions, responsibilities, key milestones, and timelines is essential. Any other pertinent details that outline expectations are also wise inclusions. Generally, the more information the CRO has, the higher quality of a response the sponsor receives.
How the RFP Process Gets Slowed Down
Several issues can slow the RFP process. One of the most common missteps that causes delays is issuing RFPs before sponsors have a full grasp of their project needs. Without the right details, CROs may develop proposals based on assumptions or their preferences, creating a poor overall match.
Similarly, omitting key details creates issues. If a CRO isn’t fully aware of what’s involved, they may default to a limited – and lower cost – proposal in hopes of securing the contract based on price alone. If they do, the budget assumptions soon prove inaccurate, creating headaches for all involved.
Choosing a CRO without vetting is another area where issues can occur. While a CRO may present a spectacular proposal, that alone is not a service-quality guarantee. If it turns out the CRO uses questionable practices, inflates its capabilities, or isn’t reputable, that can lead to significant risks down the road.
Finally, having an overly complex budget sheet slows the RFP process. While it may seem wise to require all CROs to respond using the same format, leading to simpler comparisons, the framework may not suit all operations. Ultimately, every CRO has unique workflows and processes. By forcing conformity, you’re potentially straining CROs who could easily meet your needs, all because of a reliance on a specific budget sheet. Asking CROs to provide budget summary of the common costs buckets, can help sponsors easily compare budgets.
How to Optimize the RFP Process
First, vetting CROs before sending an RFP is essential. Often, it’s best to send fewer RFPs out to vetted CROs than cast a broader net that’s guaranteed to hit unknown quantities, as you’ll be more confident in the results.
Additionally, ensure that RFPs aren’t issued until the full scope of the project is known. By ensuring all needs are identified, RFPs are more comprehensive and accurate, leading to higher quality proposals and reducing the need for future change orders.
Ideally, the RFP should outline all clinical trial details, key milestones, and timelines. It’s also wise to provide the expected number of human subjects, key enrollment dates, follow-up durations, specific CRFs requirements, and adverse event expectations.
If you do include a bid grid, keep it simple as possible. Limit the number of line items to standard clinical trial management services to allow for quick comparisons at a glance without making the review process cumbersome.
Also, include any preferred site selection criteria. This ensures your priorities are known and clearly articulated, allowing CROs to focus on your genuine needs.
Finally, if time allows, give CROs ~10 days to respond with your RFP. Have a plan for receiving proposals and allowing questions from CROs. Standardizing this process ensures all participants receive the same information and follow up.
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