Optimal design and execution of translational studies are critical for de-risking of clinical development programmes and achieving regulatory success.
The services that tranScrip provides include, but are not limited to:
- Planning of early clinical development programmes, from preclinical research through to the proof of concept studies
- Design of early clinical trials, e.g. dose escalation studies in healthy volunteers and patients, drug-drug interaction studies, food interaction studies, etc
- Review and interpretation of translational studies data (safety, PK and PD)
- Acting as members of independent safety boards
- Preparation for Pre-IND meetings
- Preparation of IND filings
- Development of biomarker strategies
- Development of PK/PD models
This case study outlines the wide and important role which tranScrip has played in Translational Medicine.
A small company with novel biological candidates needed to design a development programme to start phase I trials.
tranScrip worked with the company to establish candidate selection criteria, develop a toxicology programme, support agency meeting for review of pre-clinical plans, secure funding grants and prepare the clinical trial application.
Pre-clinical development was completed, the clinical development plan designed and a phase I study started.