While studies to test the safety and efficacy of new drugs are necessary, their success cannot be guaranteed. In fact, it’s likely that at least 80% of trials will fail.

Due to the nature of scientific and clinical research, success cannot be assured, but the chance of failure arising from the operational execution of the study can be minimised. Trials are significantly more successful when procurement teams purchase mission-critical services incredibly well. Therefore, arming the function for this activity will create a meaningful impact and value for the business.

In practice, Chief Procurement Officers (CPOs) have an opportunity to help their teams balance several tasks. On the one hand, teams must purchase the highest-quality expertise that will deliver within tight timelines while maintaining data integrity. On the other hand, they must juggle the challenges of meeting incredibly strict regulations that govern the outsourcing of clinical development work.

Procurement teams that strike this balance can help get clinical trials across the line.

So, how can CPOs secure quality expertise, on time, while utilising an outsourced model and staying compliant? Ultimately, it comes down to how they engage with suppliers.

What are pharma CPOs juggling?

Before exploring how CPOs can help deliver clinical trials through supplier engagement, let’s examine the situation.

As we have established, clinical trials have a low success rate. Additionally, they are extremely expensive. For example, only around 10-20% of clinical trial drugs ever make the market. While this number is hard to measure across the industry, the sense is that it typically leans towards the lower end of this range. Further, a small Phase III study can cost upwards of £100 million. Therefore, there is plenty of room for pharmaceutical businesses to see their returns on investment (ROI) increase.

Procurement’s ability to help more drugs reach the market is dependent on the degree to which it can secure timely, high-quality operational expertise that will deliver a good study within the regulatory framework.

The regulatory framework will impact development projects on many levels. One area is supplier selection, which, if mismanaged, can cost the business a significant amount in fines and reputational damage. Procurement can also help to ensure that other departments remain compliant in any work they outsource relating to a trial. Further to meeting regulations, procurement must also keep up to date with new regulations and help determine how these regulations impact the outsourced model and supplier activities. New rules regularly come into force, thereby creating a moving target. Ensuring compliance with relevant regulations is, therefore, a significant focus for Procurement.

Pharmaceutical companies generally use an outsourced development workforce. While the clinical trials model was once in-house, now complex trials are almost completely run by suppliers. There is a whole sector of pharmaceutical service providers, including large businesses with a wealth of expertise and value to add. That said, because this expertise is external, procurement must make an extra effort to keep supplier activities aligned with internal efforts

To manage this workload, despite its challenges, and positively impact the clinical trials process, procurement must make a concerted effort to collaborate effectively with suppliers.

How can teams really collaborate with external experts?

Working as a team with suppliers is critical to the success of clinical trials.

To support these complex trials, the Trial Master File, containing all relevant data on the trial operation, must remain up to date. At any given time, it must contain all the information regulators may want, including information relating to the various metrics and KPIs for supplier performance and oversight. This demands a large volume of data, which must be obtained from suppliers and study physicians.

With this in mind, and given all the moving parts required for a study, it is essential that procurement collaborates closely with suppliers. Procurement can help ensure that quality and time requirements are met and the study is compliant with regulations. Ultimately, by treating suppliers as an extension of the internal team, procurement can achieve so much more.

To increase supplier risk sharing and project buy-in, procurement can use a “penalty or earn back bonus” approach. In practice, this means holding back a percentage of the direct fee, which is then earned back by the supplier if they meet performance and quality goals. An additional (usually equivalent) bonus can be earned by the supplier for achieving stretch goals on the project.

Why is trust so crucial?

Finally, it’s important to acknowledge that these suppliers have a wealth of knowledge. Therefore, further to working closely with suppliers, procurement must also trust them. Supplier businesses have hundreds of PhDs, doctors and statisticians. Additionally, their operational expertise may exceed that of the pharmaceutical business sponsoring the trial.

All these highly qualified people have intellectual capital, which CPOs would be wise to access. If, for example, a pharmaceutical company runs a study on an unusual or rare disease, its suppliers will likely have more experience in the indication than they do. Not only can their experience and knowledge help during the clinical trial, but they can also help formulate an operational strategy to increase the probability of the study’s success.

In practice, this would mean leveraging the operational expertise of the suppliers, for example, by allowing a supplier to use their own Standard Operating Procedures (SOPs) or obtaining supplier input on the study protocol. Some sponsors may insist on the supplier using the sponsor’s own SOPs. This is similar to going to a nice restaurant, ordering a dish and then telling the chef how to cook it. Just like we would trust the chef to cook their expert dish to perfection, procurement teams should trust suppliers to lead when it is appropriate and required. This doesn’t mean that the sponsor is not responsible for the project, just that trust in suppliers is a crucial ingredient to success.

It’s sensible, then, for pharmaceutical CPOs to ensure their teams work as one with suppliers. By making these relationships a priority and managing them in a way that gets the most out of suppliers and frees them up to deliver a quality service on time, teams can set up their wider businesses to comply with regulations, deliver quality data and get critical drugs on the market to