Synthesis-to-Clinic
Our unique Synthesis-to-Clinic™ platform allows us to deliver 14C clinical studies as a fully integrated service. This increases the efficiency with which your programmes can be executed and dramatically simplifies the procurement process. Our platform can generate significant cost and time savings for your studies.
Synthesis-to-Clinic uniquely combines our strengths in radiochemistry and metabolism as well as in clinical excellence and experience.
Chemistry – We have unrivalled experience in 14C radiolabelling, with 10,000 custom syntheses completed to date by staff with more than 1000 years combined experience. We are directly responsible for one third of the molecules in the industry’s development pipeline or on the market.
Metabolism – We provide a comprehensive preclinical service encompassing the full range of regulatory drug metabolism studies. Hundreds of molecules have passed through our hands and our premium quality data have supported a number of internationally marketed products.
Clinical – We have completed over 100 human ADME studies to date in healthy volunteers or oncology patients. We have investigated more than 50 compounds using microdosing and microtracer techniques via different routes of administration.
We can undertake all of the key requirements of your 14C clinical programmes, including:
- 14C API synthesis
- Pre-clinical DMPK
- Regulatory affairs
- IMP production
- Clinical conduct
- Analytical support
- Reporting
Our Synthesis-to-Clinic platform provides you with the benefit of working with a single partner for your entire programme. An experienced project manager, who understands the importance of delivering your project to time and budget, is selected to work with you throughout.
For more information download the Synthesis-to-Clinic Fact sheet.
To listen to the recordings, download the transcripts or request the slides from our expert webinars (April - June 2010) please follow this link.