Director, Budgets & Proposals
April 12, 2022
Selecting a CRO partner is a critical step in executing a clinical trial. With an estimated 4,250 CROs to choose from, it’s essential that you carefully evaluate and select the partner that’s the best match for your organization. The right partner will help you navigate the challenges of a clinical trial and smooth out the ride, while the wrong partner can add headache, excessive cost and sleepless nights. As standard practice currently has it, this critical decision is typically made within just a few weeks, often at the last minute, with only a couple of phone calls, a proposal review and a bid defense. With literally millions of dollars riding on the decision, how can a sponsor capitalize on these few exchanges in order to arrive at the best decision?
While each of these interactions plays a crucial role in the decision process, this blog post is focused on one element of the CRO selection process that rides on the Sponsor – the Request for Proposal (RFP) document. Here are 5 tips (and a bonus) to consider when developing a clinical trial RFP document to maximize its effectiveness, and in return, receive a thorough, well-thought-out proposal from your potential CRO partner:
1. Provide clear background information and your objectives
During the clinical trial RFP process, it is important to keep in mind that you are looking for a partner for your upcoming trial. The RFP document sent out to the CROs selected for the bidding process should provide a brief background on your company, the investigational product, and ultimately your objectives for this product/trial. A CRO is there to solve your problems – not be one. Be upfront about what your concerns are with the study and what keeps you up at night. An experienced CRO will offer potential solutions to minimize those risks, as well as others you may not have considered. Understanding the history and the WHY behind your decisions will allow the CRO partner to make better recommendations and tailor their approach to better fit your needs. For example – if this is your company’s very first clinical trial with limited in-house resources versus being a seasoned pro with a large staff looking for very targeted needs – a CRO would have different approaches to executing these varied scenarios.
2. Set clear expectations
In addition to providing big picture information, it is important to set expectations for the clinical trial RFP process. What is the deadline for confirming a proposal will be submitted, for submitting questions and for submitting the final proposal? Do you want the CRO to bid to your specifications or their own recommendations? Do you need a ballpark budget for fundraising purposes or a full proposal to be used for final CRO selection? The RFP process is labor intensive for all parties involved, being clear about your needs and what you are asking from your CRO will allow them to better address your needs.
3. Include a responsibilities matrix
A must-have in a complete clinical trial RFP document is a responsibilities matrix. With multiple organizations typically involved in a clinical trial (Sponsor, CRO, and other 3rd party providers), a responsibilities matrix is a great way to clearly show who is responsible for each service and what is being asked of each party. It should outline how all of the moving pieces will fit together to effectively execute the upcoming trial.
4. Provide a protocol with schedule of events
Providing a protocol is key when requesting a proposal from a CRO, and without one, a budget cannot be developed. While the protocol does not need to be final (a draft or synopsis can work in a pinch), it will be important as a Sponsor to understand that costs may change by the time the protocol is finalized. If you are only providing a synopsis or a rough draft, the Schedule of Events (SOE) is critical. This will allow the CRO to estimate the CRF count and Site fees that you can expect. Changes to the SOE can have dramatic cost impact as the more data that is being collected equates to increased monitoring time (SDV) and data cleaning. In a typical study design, the study timeline, number of sites, and the amount of data you are collecting are a few of the largest cost drivers in a CRO budget.
5. Provide key assumptions / specifications
CROs tend to use multi-layered spreadsheets and/or budgeting tools with complex algorithms in order to develop a budget. In addition to the responsibilities matrix mentioned previously, a clinical trial RFP should outline the critical specifications for your upcoming trial. Having your CRO build their budget to the specifications provided while also requesting that they provide their recommendations in the proposal document gives you the opportunity to more easily compare budgets across CROs (and their complex algorithms) while still netting valuable advice from experienced professionals. While it is extra leg-work upfront for the outsourcing lead, the more details you can provide, the easier the evaluation process is as you compare costs between organizations, and the more confidence you can have that the budget you are receiving aligns with your expectations. Assumptions should include, but not be limited to, the following:
• Timeline expectations, including where in the process you are with IND and key milestones
• Number of sites (noting those you have already identified)
• Number of patients
• Number of treatment cycles to include in bid
• Countries, and if possible, the number of expected sites/patients per country
• CRF Count – while often overlooked in an RFP, the size of the case book has a ripple effect across functional areas. More data means a more complex build, more monitoring, more cleaning, etc. A 12-month study with 21,000 CRFs is an entirely different level of effort than a 12-month study with 3,000 CRFs. A CRO can estimate a CRF count based on a schedule of events, but there will be some variation in these estimates depending on the Data Management team.
• Desired monitoring strategy (e.g. all on-site, remote, 100% SDV, etc.)
*Bonus tip: Be available during the RFP process
While not part of the clinical trial RFP document itself, even the most well-written clinical trial RFP document is likely to bring up questions when under the intense scrutiny of 5-10 functional areas and therapeutic experts at each CRO. With so many eyes on the RFP and protocol, there are bound to be inconsistencies identified or differing interpretations of the RFP materials provided. Making yourself available to answer questions or provide clarifications in a timely manner during the process will go a long way to ensuring a quality bid is received. Most CROs require a minimum of 10 business days to develop a full-service proposal. Sponsors who lob over a protocol synopsis and are then unavailable for the rest of the process are unlikely to net an accurate proposal.
The clinical trial RFP document is one of the first steps in the development of the Sponsor-CRO partnership. By putting in the up-front time and effort to provide clear instruction and clarify expectations, it will make for a more concrete comparison across CROs and fruitful ongoing discussions as you narrow down your choice of CRO partner.
New to Aperio’s Let’s Make It Clear series? Check out Part 2 “Not a Time for Speed Dating” to discover 5 tips you can use to avoid a speed dating situation and get the information you need to make an educated decision when selecting a CRO partner.