Selecting the right Clinical Research Organization (CRO) is vital to the success of any clinical study. Get it right and the months that follow will be that much more enjoyable because the study is more likely to run smoothly and stay within budget. Those sponsors who have had to transition a clinical study away from a poorly performing CRO to an alternative supplier, mid-study, will be acutely aware of the pain that this can cause and the need for a thorough vendor selection process. The Request For Proposal (RFP) is a vital component of that process. A well-defined and comprehensive RFP creates the best chance of selecting the most appropriate CRO, or combination of CROs, to complete the project.
There is great variety in the way RFPs are presented to CROs by pharmaceutical, biotech and medical devices companies. They range from a dozen bullet points in an email to a detailed RFP specification sheet complete with final study protocol and “bid grid” spreadsheet. Some companies choose to host their RFPs on e-procurement platforms. For those sponsors who really want to explore the market for the most suitable CRO for their study, a well prepared RFP makes for the best chance of an informed and correct decision. It can also avoid the need to spend time on further evaluation (bid defence, reference checks, audit etc.) of CROs who could have been weeded out at the RFP stage.
There are a range of RFP manuals and templates available. However, sponsors should be wary of over-reliance on a generic template because it generally needs to be heavily adapted to the particular type of study in mind. Ideally the clinical research organization selection process should only start when a final protocol is available. Although ballpark pricing is often required for budgeting purposes, sponsors should be cautious when requesting a quote based on a draft protocol. Budgets can be revised dramatically on receipt of a final protocol which can alter funding and time requirements.
There is always merit in asking a CRO to review the RFP prior to finalization so that they can include a standard set of assumptions. CROs have seen so many RFPs it makes sense to tap into their experience by asking one to help construct the content and format of the RFP. They may be delighted to get the opportunity to lead the way.
RFPs should not be just about doing a cost comparison. They are an excellent opportunity to ask focused questions about the CRO’s experience, approach and expertise related to the planned clinical study. Questions can also be included that will encourage the CRO to suggest important tweaks or improvements to the study design.
The RFP should always request a detailed Project Plan thereby ensuring that tendering CROs think through the resourcing and timeline requirements. It should also request curriculum vitae (résumés) of the key personnel who will be assigned to the study. Unfortunately it is not unheard of in the industry for a CRO to present their highly experienced “bid defence” team at the vendor evaluation stage and then deploy a less experienced team, that the sponsor has never met, when the business has been won and the study starts. The sponsor should seek assurances that they will receive the team presented and that they will not be moved mid-study to another sponsor’s project. Any change of personnel should be limited to unavoidable reasons, such as long-term illness or change in employment status.
Cost Comparison and Assumptions
On the cost side, the absence of like-for-like comparisons continues to be an issue in the industry. CRO cost models vary from company to company and sponsors often only provide the key parameters, leaving it up to the CROs to create their own assumptions in areas such as number of sites, statistical outputs, data management queries, concomitant medications, adverse events and so on. It is better to have all vendors quote using exactly the same assumptions.
Where a CRO feels the assumptions are incorrect based on their experience of the particular study type, these should be listed separately in the proposal with the cost implications. If the sponsor expects the CRO to work to their own SOPs and standards these documents should be provided in time for them to be analysed and the implications understood prior to a formal response to the RFP. Sometimes CROs apply a “complexity” factor within their quote models which affects the overall pricing. This “complexity” factor may increase or decrease depending on the processes and tools to be used. Sponsors should also be clear about those aspects of the study that they plan to handle themselves.
Some sponsors have developed detailed bid grids to enable comparison across submitted budgets from competing CROs. Occasionally sponsors request a price per additional item/task e.g. per additional patient, month, query etc. Because pricing is usually hourly driven CROs often find it difficult to match or ‘fit’ pricing into a particular grid. Sponsors and CROs alike should be aware that such pricing for additional items can become inaccurate especially if some of the study parameters change.
Once a sponsor has received the completed proposals, the decision process can be made easier by very simply giving a rating of 1 to 10 for each of the key selection criteria within the study such as: price per function; basis for stated recruitment rates; monitoring expertise; breadth of service; technology; therapeutic experience; geographical reach; capacity; scalability; financial stability; understanding of the study etc. It usually helps the CRO, and improves the overall quality of the proposal, if the sponsor outlines its key selection criteria within the RFP. If a CRO has a niche focus or speciality (whether it is a therapeutic area, biometrics, technology or any other specialist expertise) this should also be taken into account. The total score for each CRO can be displayed in a single matrix. This is a useful decision making tool, but that said, a sponsor should never ignore their gut feeling either.
It is not always the best idea to contract the whole study to one CRO. Though this might initially seem like the simplest solution, it can also be a risky one. Splitting out the clinical data services and the clinical aspects of a study allows a sponsor to use two separate CROs that are specialists in their own areas. There is very little additional project management time because data focused CROs that handle the collection, management, analysis and reporting of clinical and safety data are adept in liaising with another CRO to obtain data and feedback on queries.
RFPs for Multiple Studies
When writing an RFP for a programme of studies, sponsors should ask CROs to seek out efficiencies should there be similarities from one study to the next. Consideration should be given to centralizing the clinical data services for multiple studies into a single vendor to avoid repeated set-up costs and to receive volume discounts on technology license fees. This approach also enables sponsors to obtain maximum CRF/eCRF re-use from one study to the next and to hold onto the same programmers, statisticians and medical writers so that the CRO builds up a familiarity and efficiency with that particular sponsor’s templates and requirements. With such a foundation it makes it easier to use multiple CROs for the clinical aspects of studies where geographical diversity and specific therapeutic expertise cannot be found within the same CRO every time. With these benefits in mind, the RFP should be designed in such a way that the clinical can be separated from the data handling functions.
The value of obtaining references can never be underestimated. RFP's should request contact details of the CRO's customers who have placed similar projects with that CRO. Questions regarding the CRO's financial stability do not necessarily need to be included in the initial RFP but should certainly be assessed prior to contract signature. Such an assessment should be done by one of the sponsor’s financial experts who will be best qualified to spot warning signals when evaluating 3 years’ worth of audited accounts.
In summary, a well designed RFP will allow sponsors to assess value over price. It can avoid a lot of unnecessary heartache over the life of the study, making the sponsor’s experience of the CRO one that meets or exceeds expectations in terms of study duration, efficiency, expertise, delivery, quality and adherence to the original budget.
Related Blog Posts
- The Benefits of Centralizing Clinical Data Services
- Making a Clinical Research Organization Project Smoothly