Clear Scope of Work Specifications Makes for Strong CRO/Sponsor Partnerships

The maxim 'Time spent on reconnaissance is seldom wasted' is apparently taught to all military strategists, even though it is unclear who actually first coined the phrase. In terms of optimizing the sponsor/CRO partnership, it can serve as a very useful piece of advice in two distinct ways—one positive and one negative.

Starting with the positive—the more time the CRO takes to discover the full extent of what the sponsor needs, the more likely the resulting partnership will become a successful one. Conversely (the negative aspect)—if the two parties regard the bidding process as an adversarial battle, with one intent on gaining a clear advantage over the other, then it is more likely the project will descend into non-trust somewhere along its path.

In terms of optimizing the sponsor/CRO relationship it is, therefore, crystal clear that the final proposal must represent a win for both parties. Easier said than done, perhaps? But there are some logical steps that can be taken that will increase the chances of this optimal situation. A good definition of a healthy sponsor/CRO partnership is when both parties truly care for each other’s business.

Granularity is the key

It is imperative to get things right from the start, which is why reconnaissance is so vital. Time needs to be spent digging as deep as possible at the 'discovery phase' to determine exactly what the sponsor needs; what they can bring to the table; and their understanding of standard processes used in clinical trials.

This approach is even more important if the sponsor has little or limited experience of working with a CRO or previous trial experience in general, which can often be the case with virtual start-up biotechs or small pharma. It's easy for a CRO to ‘assume’ all sponsors understand what is required of them to fulfil key aspects of the trial. Once underway, when this is not the case, this can result in the CRO having to take on more work themselves to fill the gaps, which may have cost implications, or may mean a delay while the 'assumption' is rectified. For small virtual companies of 5-10 staff the CRO needs to treat them like a couple building a home for the first time—not only does their lack of experience challenge them with not knowing how to respond, but it also challenges them with not knowing what to expect.

Recently we had a trial where it became clear that the sponsor had not realized that it was necessary to have investigative product labels translated into the native language of each country in which the trial would be conducted. The sponsor was managing this aspect of the study, but fortunately, delays were minimized by working with our Country Leads to manage the translations on behalf of the Sponsor. It is an example where small assumptions can lead to bigger challenges and it is again why it’s so important the CRO understands prospectively where and where not a sponsor teams’ expertise and understanding resides.

The lesson here for the CRO is to have a 'granular' approach at the 'discovery phase', and listen for key phrases that ring alarm bells, identifying these gaps in knowledge and experience and allowing for appropriate measures to be put in place to mitigate them from the outset. Checklists and task ownership matrix tools are also helpful in discussions with sponsors to communicate all tasks at hand and who will be responsible for them. Sponsors that partner with a CRO that specializes in working with smaller to mid-size companies find their experts, in areas such as regulatory, project management, clinical monitoring, data management, and biometrics to manage and oversee their studies as a partner, understanding the importance of their product as if it were our own.

Ensuring the right cultural fit

As many smaller companies will only have one or two drug candidates, their whole future depends on the related clinical trials to be top quality, on budget and on time. Suffice to say, it is imperative that their chosen CRO partner really understands the scope of work from the beginning and builds the trust in this area from the start. This trust is formed through excellent initial specification as well as ongoing communications with senior staff, with relevant expertise and experience, are on hand from day one and throughout the entire duration of study, not just at the bid defense as with some CROs.

Although establishing an accurate Scope of Work of all study specifications is vital, the real success is also dependent on the staff on both sides being on the same page in regard to who is doing what, when and how. If the sponsor's senior staff like a very formal approach to reporting, they are likely to want to see metrics and a formal style from the project manager. It is very important to match the Project Manager’s chemistry and style with the client. That is why we always try to match working styles as well as clinical experience. This may come as a surprise to some, but the success of a partnership is not just dependent on ‘hard’, measurable parameters but also on communication and chemistry. Again, optimizing the sponsor/CRO relationship is all about taking the time, and putting in the necessary thought and energy to get things right from the very start. Staff on both sides who trust each other are far more likely to enjoy face-to-face meetings, make them as productive as possible and feel less inhibited about talking frankly about any problems and their potential solutions. This is critically important particularly with newly formed sponsor in-house teams as you must feel free to able to give good news and constructive comments. Study challenges and associated communications or even just constructive advice that may have a large cost implication, is always better to have early and often so that everyone can have time to adapt—even if that means reconsidering trial parameters or looking for additional funding, resources, sites, and so forth.

Resource continuity is another key to success. For example, we try to ensure the PM who starts the study is there at the end to celebrate the successful completion of a trial, even if he or she has been promoted during that time they will still remain a part of the team and will see out the existing trial. There is never a situation where one of our PMs is whisked away, because of another opportunity or because of a larger study with a bigger budget which sometimes happens at larger CROs.

Beginning with the end in mind…

The most important focal point in any trial is patient safety and monitoring the efficacy and safety of the drug itself. Beginning with proper planning and having attention to study specifications and scope of work is the best way to guide a safe and efficient trial in the end.

In summary, getting things 'right from the start' has to be the logical first step in building a successful, long-term relationship. Don’t be put off by anyone who is open or frank early on and provides the facts, as in life your best friends are often the ones looking out for your interests and willing to tell you how it is…not just state what you want to hear. Your partner CRO cares about your business as a top priority.

Leslie Jones is the Executive Director—Clinical Operations (NA-EURO) at WuXi Clinical​