What makes an excellent RFP?
Sponsors that are looking to hire a CRO to provide clinical trial services need to create and issue a request for proposal (RFP) describing the specific project they need to be carried out. This document will elicit bids from potential vendors, which will ultimately help select a CRO to be in charge of one or several aspects of the study. Sounds simple and quite straight forward, but an RFP is where everything begins, so it is important to get it right. An inadequate document leads to inconsistencies among bidders, a poor project, bad budget management and a problematic relationship between the sponsor and the selected vendor.
To avoid this, sponsors need to take into account a few basic steps while writing their proposal for CROs bidding on a project. These steps include careful planning, providing the right information to vendors and getting to know the CRO that would potentially be carrying out a specific clinical study. It is pretty much like getting to know someone to see how compatible two people are: are we right for each other, are we on the same page, is our relationship going to work, how can I be sure I can trust you before I decide to commit to you…? Considering that clinical trials are one of the most expensive tasks for pharmaceutical and biotechnology companies, excellent RFP writing should be a priority for companies.
Sponsors need to take the RFP process seriously and spend some time planning it, even if the other deadlines of the drug research and development processes are also urgent. This means sponsors need to understand their outsourcing needs very well (for example, what type of CRO is needed- niche or full service?) and have a solid clinical plan before actually submitting an RFP document to vendors. They should also give CROs enough time to respond in the most thoughtful and detailed way. As such, a good RFP process should provide time for questions about the RFP from CROs, bid defences and a final decision process on the selected CRO.
Providing key information
CROs are not mind readers, so pharmaceutical companies looking to conduct clinical trials need to provide clear and detailed information of what they need exactly to ensure that the trial will be carried out correctly and without any changes of scope along the way. Otherwise, vendors might not deliver. For example, the sponsor should provide background information on the compound, a protocol summary, specific project timelines, a schedule of assessment and which clinical services they need. Even though it is good to let vendors make some recommendations, the lack of proper and vital information in the RFP could lead to CROs making their own assumptions, especially regarding budget assumptions, just to look good and win the bid. This could result in an unrealistic project plan, inconsistencies in the assumptions made and pricing offered, and a waste of time for both parties.
Getting to know the CRO
RFPs are also a way to make CROs provide sponsors with important information that will let them select a winner. Ideally, the decision would not only be based on low budget proposals (low budget can mean low service!). Ultimately, CROs will be conducting the studies and will be responsible for the results, so sponsors should ask for information that would allow them to make the wisest choice, such as references from other sponsors (at least three), previous metrics and measurements for other sponsors, financial statements, turnover data, project team CVs, summary of the team's experience running similar trials, and any other relevant information that would allow the sponsor to determine how compatible the vendor is to meet its needs.
As seen, choosing the right CRO and writing an RFP is obviously not just about quickly giving a few pointers, signing a check and expecting to have everything running smoothly. People from the industry tend to say that partnering with a vendor of the same size and values is the way to go to get excellent trial results and a good relationship based on trust and frequent communication. The only way to determine this is by investing the right amount of time and energy on a solid RFP process. In the long run it is worth it.