Outsourcing CMC for your Clinical Trials
When outsourcing CMC support for your clinical trials, the analytical package supporting it can have hundreds of different elements requiring well-coordinated capabilities and specialized expertise. Making sure that your CRO partner can meet all the criteria required is essential to a favourable outcome. Selecting the right partner at the start to follow each of the development phases saves time and money. This approach provides:
- Continuity of technology transfer across each clinical phase
- Increased reproducibility of analytical methodology
- A more responsive communication process between partners
- Lower quality assurance costs, with fewer audits
Storing and testing the API, Raw Materials and Formulation with the one provider has a positive advantage for all the above.
Source BioScience as a market leader in stability storage, is one of the few specialist service providers that can provide stability storage and capacity across the wide range of ICH conditions plus bespoke temperatures and humidity. This, along with our Analytical Division, which is a MHRA approved (cGMP) laboratory that specialises in the provision of CMC laboratory services for all phases of drug development provides a rugged yet cost effective solution to meet the appropriate quality and regulatory standards. Together we can create tailored solutions.
Head of Sales – Analytical Chemistry
For further information and prices please contact us or call +44(0) 115 973 9012