tranScrip’s Clinical Development and Operations team has worked with many clients on the design and successful implementation of clinical programmes for regulatory approval and product differentiation.
tranScrip interacts with thought leaders and regulators to guide programme design and is frequently involved in the development of protocols, medical monitoring and preparation of study reports and summaries. For small and start-up companies, tranScrip has established their trial oversight processes to ensure GCP compliance.
Well-designed global clinical development programmes combined with therapeutic area expertise are critical to achieving a successful outcome.
The services that tranScrip provides include, but are not limited to:
- Defining optimal development pathways for regulatory approval
- Design of Phase I to Phase III studies
- Medical monitoring of Phase I to Phase III studies
- Strategic statistical support to optimise study design
- Risk Management planning
- Support with selection of a CRO
- Project management and CRO oversight
- Writing or updating of SOPs
- Writing of:
- Clinical Study Reports
- Investigator Brochure
- General Clinical Operations support
- Provision of complete virtual team for small biotech or spin-out companies
This case study outlines the wide and important role which tranScrip has played in Clinical Development and Operations.
A small biotech company moved its product into clinical development and needed to complete a phase II study on limited resources before receiving further funding.
tranScrip provided clinical, regulatory, drug safety, and operational support along with internal staff training.
Phase II study completed on time and within budget. Operational systems successfully inspected by MHRA.