09 Aug 23
By Sonjoy Brahma
The selection of vendors for a clinical study can be approached in many ways, but not every company has the luxury of a clearly devised clinical operations, outsourcing and quality assurance department to support these activities. Every company, however, that runs clinical trials will be faced with procurement decisions. A formally devised selection process is critical to ensuring success.
Companies often face knowledge and resource limitations when entering into the clinic for the first time. Careful thought is needed on how to approach these contractual partnerships which can hamper your development timelines and quality of data if they are not right. Smaller organisations initially may only perform limited vendor selection activities which logic does not lend towards building these capabilities within. Nonetheless, selection of vendors is a critical tactical decision that can leave you with painful wounds in the long run and can be both costly and labour intensive if issues arise due to selection of the wrong vendors to suit the specific trial.
Ultimately the diligence on selecting and oversight of vendors is the responsibility of the sponsor of the research.
Partnership models are often in place for large biopharmaceutical organisations. Big service companies particularly CRO and Central lab services have considerable economies of scale and operate internationally and generally represent more matured relationship models on a big scale. They generally behave like a production line for streams of volume work; established ways of working are put in place with common processes, including quality assurance methods, to ensure speedy interchange between projects. Synergies are built between companies removing time spent learning each other’s processes and contracting, however at the expense of choice and flexibility, which could be detrimental for less run-of-the-mill studies, and more costly as an outcome. For smaller and emerging organisations, it is unlikely that these type of arrangements could be beneficial and choosing the right CRO/vendors for the specific study is a business critical decision.
Devising selection criteria that are suitable for any company or development programme is never a “one size fits all” exercise. Every company has differing priorities and there are also many positives and negatives of each potential suitor in any functional area. Some services are heavily dominated by large companies whilst very specialist services may only have a few players. Working with a ‘mega’ top 5 central laboratory, for example, might be a sensible choice for a 10,000 patient Phase III study; however, would probably not be so suitable for a small biotech in Phase I.
A key success factor is fully understanding the service offering and how it might be bundled with things that you may not need; without knowledge in these areas it is easy to be mis-sold. To enable cash-efficient development, you should to start from a principle of minimum standards that are required and are fit for purpose. Smaller pieces of work may not be of interest to larger vendors, and they may not engage adequately or may even go through your diligence process but not competitively bid for the work deliberately. It is extremely beneficial for you to have access to people that are familiar with the early phase service landscape and have first-hand experience working with companies that are organizationally aligned to your requirements.
Being able to compare bids across vendors ‘like for like’ is an absolute must. Without a standardized ‘Request for proposal (RFP)’ process, it is very easy to be hypnotized by fancy brochures, pretty presentations and claimed cost savings from one particular vendor. The reality, however, may be that it is not cheaper at all and critical things you need may have been omitted, e.g., 200 data transfers or data services for cleaning your vendor data, which other vendors had included. The devil almost certainly always lies in the details. It doesn’t matter if your assumptions change later on; what matters is that your vendors are providing feasibility and costs based on the same assumptions.
Running a fair and transparent process is beneficial to all parties involved. Set out the timelines for the RFP process and inform all vendors that it is a competitive process. If one vendor requests additional information, share the response with all. Be honest about negative decisions for each vendor and ask for feedback on the process run. Building relationships and learning about multiple vendors may reap rewards down the line, where a vendor who did not quite meet the mark for your Phase 1 study may be a perfect fit for another asset or for Phase 2.
Once you have reviewed the proposals and short-listed those that you believe are able to conduct the work, it is critical to enter into a dialogue to assure that the company is the right choice. Typically, a “bid-defence” meeting is held with multiple people from your organization. This should take place with the team who are going to work on the project day to day. Adequate time should be scheduled to enable a deep-dive into the proposal and to answer key questions pre-defined by the hiring company, such as, what are the lines of escalation if there is an operational dispute? Is there a high level of bureaucracy and inflexibility? Is the 16-week standard set up time modifiable? How long does contracting take? It is good practice to have the hiring company team complete “scorecards” for each vendor assessed so that a data-driven decision can be facilitated.
Although cost is a considerable factor in the selection of vendors, it is generally best to shortlist candidates based on ability and experience first. This is a practical move since negotiating on the nitty-gritty of costs can be time consuming for a company but also a vendor will be more willing to spend time on considering efficiencies etc., if they know they have a good chance of winning the work.
Depending on the nature of the work, approaching at least 3 companies is recommended to obtain a good understanding of the likely cost. No one wants to come across as the ‘tourist in the Souk’ when entering the marketplace and ‘special’ price may be considerably more than the ’book price’ for other clients.
Most (not all) vendors will accommodate a discussion on discount and (like the “tourist in the Souk” analogy) negotiation is expected. Don’t be shy to raise this discussion, especially when the decision mostly will be determined by cost. A vendor would prefer cost be raised as an issue than be discounted without the opportunity to counter propose.
It may be beneficial for a company to consider fixed-price terms to support, for example, stability in financial reporting. The value of the contract will likely be a bit higher than a time and materials basis but suits many small companies well.
Otherwise, a mile-stone payment basis is common, whereby there is typically a start-up fee followed by a series of payments linked to significant achievements such as first subject dosed, last subject dosed, database lock, etc.
Alternatively, some vendors may lend themselves to a time and materials contract, for example, a consultancy or ad hoc services.
Remember, it is key to ensure that requirements for ICH-GCP and data protection are incorporated into contracts, including a clear description of roles and responsibilities between the contracting parties.
Outsourcing decisions on clinical vendor are not as simple as they might seem to the unfamiliar; however, the responsibility from a regulatory perspective firmly lies with the sponsor. Making the right choices is vital when planning for successful clinical trials. Robust diligence and a formal qualification process should be part of all clinical procurement decisions.
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