In our blog ‘What makes a sensational CRO website?’ we discussed how the top contract research organisations have the market share, making it harder for smaller, more specialist companies to share some of the pie. In this blog, we look at outsourcing strategies in clinical trials, whilst considering the external perception of CROs in the life science industry, and the impact of ICH E6 (R2) on vendor management.
Earlier this year, we attended SCOPE 2020 in Orlando, Florida. It’s fair to say that we were surprised with how negatively attendees spoke about CROs. Of course, we understand the challenges in maintaining a strong, collaborative relationship whilst focusing on tight financial and time constraints, but we hadn’t quite appreciated how much a life science company could feel like they had lost control of their trials simply by outsourcing to a contract research organisation. This is of particular prominence since the release of ICH E6 (R2) Good Clinical Practice, which is revision 2 of the international ethical and scientific quality standards for clinical trials in human subjects. As one speaker mentioned, he views the relationship between a life science company and a CRO to be similar to a marriage; there are good days and bad days, and the overall health of the relationship is pinned down by effective communication and transparency.
It is probably fair to say that large life science companies are primarily focused on preferred providers and governance, whilst small life science companies are more heavily influenced by high quality and functionality. ICH E6 (R2) presents the importance of sub-contractor oversight, considering cost, quality and timeliness. By including ‘sub-contractor’ this includes functions that are subcontracted to another party by the sponsor’s contracted CRO. It is therefore understandable why there is additional pressure on the sponsor company to try and control the implementation and outputs of all vendors involved in their trials, even if they are not managing them directly.
On face value, the suggested approach is to really break down the sponsor company and understand what their core competencies are. What is their arsenal? If scientists are a core competency, keep that work in house. If X, Y and Z are less-developed, then look to outsource those portions of work. Outsourcing needs can also be time-based depending on resource availability and location, so sponsor needs may change over time, especially as a life science company sees a period of rapid growth. Be fluid in your strategy. Be holistic. And be prepared to compromise.
For the CRO, setting up the infrastructure for a life science partnership can be a significant investment of time, but it is best to set up for the long haul. Identify a team member to lead this infrastructure, ideally somebody experienced in clinical operations and client relationships, who can put the technology and processes in place needed to underpin the partnership.
Ensure alignment with the sponsor on their standards, templates and specific ways of working. Discuss their required expectations vs. their desired expectations. Develop robust plans that allow the sponsor to have all information they need when it comes to third party vendors that are sub-contracted. Think about what additional steps can be taken in order to provide the required level of information to put a great foundation in place.
Could virtual tours be used to demonstrate facilities? Will all sub-contracted vendors be attending and contributing during kick-off meetings? Will there be quarterly check point meetings to discuss the current status of the relationship? Try to keep the customer relationship manager on for the long haul, even if they are not working on the day-to-day projects once the relationship is established.
Having one primary relationship manager instils a greater level of trust and a feeling of importance. Consider whether the alliance management structure can occur at both the executive level and the operational level, as this is of significant importance for overall governance, communication and transparency.
You’re now fully immersed in the partnership. As with all relationships, it will not be an easy road; there will undoubtedly be ups and downs. As a CRO, it is very important that the sponsor company feels committed to the relationship, as well as your internal team. Take time to laugh together, always meet with a warm greeting and build a healthy relationship. These are some of the easy rules for a happy marriage. Alas, the very nature of clinical trials is high-pressure with a significant degree of fluidity, and this can create obstacles that have to be navigated along the way. If the relationship is strong, it is far easier to navigate such obstacles. This is when the alliance management at both operational and executive-level is of utmost importance to the mutually beneficial relationship. Again, communication and transparency.
An important piece of the partnership puzzle is the ability to implement the alliance across all projects that you are working on together. Information is powerful when it is shared, so ensure that it is captured and used wisely. The client relationship manager can be the cornerstone in this, pulling together the critical information from multiple projects/teams and ensuring successful cross-contamination, both for the wins and the losses.
If things really aren’t working with the existing framework, take time to consolidate, realign and strategise. Sometimes individuals just don’t click, which may mean making changes to the operational team. Other times, certain things have slipped by the wayside during particularly busy periods. Be graceful, take time to apologise and accept responsibility where necessary. Always be prepared to review processes and implement lessons learnt, even it means going the extra mile to salvage a relationship that needs some TLC.
The final thought
One final thought from the rules for a happy marriage – never yell at each other unless the office is on fire.