SCOPE OF WORK

Fully outsourced clinical development planning and conduct for the first-in-man study.

THE CHALLENGE

Provide full clinical development support to a client with little clinical research experience.

THE CLINTEC APPROACH

As the client had no internal clinical research staff, ClinTec set up a core team of experts, including a key opinion leader, to support the completion of the clinical development plan, detailing the Phase I–III development strategy. This plan was developed with input from ClinTec’s Clinical Operations, Biostatisticians, Regulatory Affairs and Medical Writing teams to help the client to understand the requirements underpinning the clinical development program, and to agree on the most suitable study design for the first-in-man study.  The study design was also discussed with the Regulatory Authority to ensure its suitability before the protocol was developed.

THE OUTCOME

The clinical development plan was completed within short timelines to define the product’s route to market and determine the approximate associated cost.  The first-in-man study clinical trial application received approval from the authorities without any objections and the study was rapidly initiated thereafter.