Development of an operationally feasible clinical pharmacology package: US Biotech

The Challenge

Aptus Clinical was asked by a US-based Biotech to assess whether the clinical pharmacology programme for their lead oncology asset could be conducted in healthy volunteers rather than patients

The Solution

An expert panel was immediately convened, made up of specialists in toxicology, pharmacokinetics, clinical pharmacology and project management

The Outcome

A thorough assessment of preclinical and clinical data was undertaken and high-level feedback was given to the client only one week after contract signature. The client also received a comprehensive review document with detailed recommendations and justifications

The Feedback

The client was impressed by the quality and speed of review. Aptus Clinical was subsequently asked to re-design this programme and were able to confirm operational viability through detailed site feasibility

Client Feedback

Aptus Clinical clearly demonstrated they have the expertise and connections to evaluate this scenario thoroughly. They were very easy to work with and the quality of the output we received, together with its speed, was impressive

Clinical Pharmacology Leader , US Biopharmaceutical Company