CROS NT is currently providing an operational and a consulting team to a small pharma that specialises in rare diseases. Our client was setting up a new department that required a flexible resourcing solution for data management, biostatistics and statistical programming to supplement their existing small team. We assembled a team that is highly experienced and can adapt easily to the challenges of a new department. What is more, it is independent and is able to work without oversight.
The client company had no internal biometrics group and has requested specialised support in various fields including:
- Vendor oversight
- Regulatory interactions
- SOP creation.
Specialist skills were required from the CROS NT project team across multiple areas as tasks would change frequently according to the companies needs.
Another major challenge was that the client company did not require full-time resources and as a result could not commit to a standard FSP model. Flexibility was a key requirement along with assigning the most appropriate resources for the specific tasks that they required.
Our solution was to establish a micro-FSP arrangement with the company where a supplemental biometrics team was flexibly embedded into the company team on a partial FTE basis:
- Full biometrics capabilities were covered with senior resources being assigned to data management, biostatistics and statistical programming activities
- The team is coordinated by a dedicated and experienced FSP manager who supports and facilitates activities with the client, advises on their vendor interactions and support needs
- The FSP manager is also an operational team member and could also offer general Biometrics advice and insight where required.
As a mid-sized CRO, our employees gain more exposure to non-standard activities that they may not get similar experience to within a larger CRO such as SOP writing. Our highly experienced team were able to adapt easily to changing requirements and tasks of a new department and were instrumental in supporting the set-up of processes.
Thanks to the introduction of the FSP manager, we are able to ensure seamless interaction and coordination of activities for the client.
The micro-FSP approach offered by us allowed our client to have dedicated resources available for its projects with flexibility to change.