Vendor selection is a critical component of ensuring clinical trial success. A 2015 report (1) suggested that clinical outsourcing penetration will reach 72% by 2020- nearly 3 quarters of all clinical trials will be outsourced to professional CROs. The process of vendor selection and management may be managed by the clinical operations teams within smaller companies, or by outsourcing and functional groups within larger organizations. The RFP process is a critical part of vendor evaluation, involving significant effort from the sponsor and CRO to ensure that a well-constructed, accurate proposal is created which can deliver what the sponsor needs.
We talked with Friedhelm Hornig, Executive Director Biostatistics and Data Management Operations at Cytel to gain his insights on some of the key success factors for ensuring the best responses to your requests for proposals. Friedhelm leads the Proposals group at Cytel, and importantly is also an integral member of the operational delivery team. With decades of experience in large pharma, within operational management of biostatistics, programming and data management, Friedhelm is well placed to look at the process ‘from both sides of the fence’.
From Friedhelm’s point of view the key to success is clarity in expectations and needs, for the CRO to be able to fully and in detail understand what the customer wants and needs, and then be able to suggest the best possible solution for the customer needs. Thus, more information is almost always better than less in this context. This enables a better and fair comparison between competitive proposals, and encourages tailor-made proposals, versus standard off-the shelf solutions.
This may sound a bit cumbersome and tedious, but in the end it pays off: Investing into thinking about what you need and communicating this in your RFP process is often hard work, but it helps to avoid surprises, change orders and, overall, disappointments.
So, clarity and communication are key and it’s critical to have considered as many of the aspects as possible of what is required before issuing the RFP. Using the picture used above, Friedhelm argues against a model of "throwing an RFP over the fence", but rather advises extensive interaction and cooperation at the RFP stage.
Beyond the standard parameters of a scope of work, like timelines, patient numbers, geographic areas etc., there are other areas which are useful to consider:
With most clinical trials now deploying EDC systems, it is useful to articulate to the CRO your preferences with regard to EDC system, ePRO systems, and other technologies. These can be important cost drivers in your study. Do you have a requirement to use a particular system or are you happy for the CRO to make a recommendation?
When we put together proposals, we can comment on the suitability of analyses, or how many outputs you might expect. However, standards and expectations vary between sponsors, and so, to ensure you can compare apples with apples it is useful to specify the number of outputs (and datasets) you expect or usually see in your setting. Of course, we can also provide a budget based on our recommendations, and we often do this, when we think estimates are unusually high or low.
Needless to say that these numbers change during the protocol and analysis plan development process, but the expectation is that initial estimates are as realistic as possible.
CDISC Compliant Outputs
With CDISC submissions to become mandatory many sponsors request CDISC compliant outputs for their studies.It’s an important question to consider and we often discuss with sponsors the best route to take depending on individual circumstances.
Despite the best planning and best of intentions it can happen that an RFP is issued to CROs later than intended. This can be because of budget approval delays, decisions taking longer than expected or perhaps a change in resource plan which might leave a particular project requiring outsourcing unexpectedly. Where possible though, it’s helpful for the management of the RFP for the CRO to have an industry standard 10 day turnaround, or longer for involved projects, like large and complex studies, or pooling and submission tasks. This allows for careful communication and discussion to take place between the sponsor and CRO, for questions and clarifications, and ideally a scoping discussion. Having enough time built into the process ensures that the CRO has the opportunity to consult with the sponsor as required.
It’s important to get the scope of the project defined accurately from the start, and a realistic operational strategy and budget prepared. Often, it is hard work, for both sides, but it pays off - for both sides of the virtual fence.
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Friedhelm Hornig has a degree in statistics from University Dortmund (Germany) and over 25 years of experience in the pharmaceutical industry. He started at Grünenthal GmbH in Germany as a clinical statistician, and then has worked in Ciba/Novartis, Switzerland for 23 years, in different functions and therapeutic areas. He has led teams to a number of successful global submissions in different indication areas, like dermatology, bone, arthritis, cardiovascular, etc., including biologics. He brings experience in modern approaches from dose finding to phase IV, and handling critical issues like safety signals. Since August 2015 he is at Cytel, as Executive Director of BDM operations, leading statistical aspects of projects, driving process improvement initiatives, and mentoring statisticians. He also serves as a voting member of a Data Monitoring Committee.