Services

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 

Case Study

This case study outlines the wide and important role which tranScrip has played in Translational Medicine.

Challenge

A small company with novel biological candidates needed to design a development programme to start phase I trials.

Solution

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.

Result

Pre-clinical development was completed, the clinical development plan designed and a phase I study started.