Case Study
CLINICAL TRIAL APPLICATION SERVICE
Suite 2, Ground Floor, Field House, Station Approach, Harlow, Essex CM20 2FB T +44 (0)203 911 9410 F +44 (0)1279 418 964 diamondpharmaservices.com CLINICAL TRIAL APPLICATION SERVICE The CTA team at Diamond Pharma Services is integrated into the Regulatory Development Department. The team has extensive experience in CTA activities for a wide range of product types. • New chemical entities • Biologics • Advanced therapy medicinal products (gene & cell therapy). Diamond have expertise advising and supporting: • CTAs submitted to many EU national competent authorities • EU wide competent ethics committee requirements • Voluntary Harmonisation Procedures (VHP) • Genetically Modified Organism (GMO) applications • Substantial amendments, end of trial, etc. The team can offer both outs