Changing critical vendors like CROs or clinical supply partners mid-way through a clinical trial, or between phases, can feel like climbing a mountain if not managed properly. However, there are times when a switch is necessary due to performance issues, company mergers, or other critical business reasons. This change brings both logistical and relational challenges.
The first major challenge is the operational gap that can occur as one partner winds down activities and before the other fully ramps up. Enrolment may lag, data may not be cleaned and monitored as efficiently, and drug supply continuity could be impacted during the transitional period. Knowledge transfer is critical to minimise this gap, but takes significant time and resources. Regulatory documents may also need updating to reflect the vendor change.
Building relationships and trust with a new vendor also takes time. Lack of established rapport can lead to miscommunications and misalignments early on. Moreover, the switch can negatively impact existing study team morale and momentum as they adapt to new processes and ways of working with the new partner. Careful communication and change management is important to maintain productivity.
There are also a number of budget and timeline implications. Contract termination and initiation, knowledge transfer, and getting the new partner up to speed may drive up expenses. The timeline for completing the study may also extended to some degree.
Switching clinical trial partners like CROs and suppliers mid-study should not be done lightly. However, proper planning, communication, knowledge transfer, and transition management can mitigate the risks and challenges involved. With a thoughtful approach, studies can successfully navigate a vendor change while minimising disruptions.
Ton van Beijsterveldt of EarlyHealth Group will be presenting at COG Europe taking place in Milan, Italy on 10th & 11th October. Ton’s presentation will share the obstacles and barriers faced internally when making a switch to a new supplier.