· Our experience encompasses obtaining clinical trial approvals and registration of new chemical and biological entities, as well as established active ingredients. We can also provide assistance with post-registration activities, such as variations and renewals.
· Patient consent, safety and regulatory compliance are our primary concerns when conducting clinical studies. We work closely with our client's own drug safety department to provide safety surveillance and prompt, accurate reporting of serious adverse events.
· All activities are performed in accordance with ICH-GCP to ensure all investigational sites are compliant with all applicable regulations and protocol requirements.