We can provide all the design and data services for P1 -P3 clinical trials. Trial design and sample size, protocol, SAP  and CRF development, data management, statistical analysis and medical writing, all to GCP standards.

Having one company responsible for all the non-patient related aspects of a P1 -P3 trial ensures that all the critical aspects are fully integrated so that

• the study design addresses the key questions
• the protocol will implement the design
• the CRF will collect the data in the right format for the analysis
• the analysis will create results in the right  format for reporting
• the  medical writing at the end of the study (a time critical stage) is fast and accurate

Quantics can provide all these functions, to GCP (or GLP) standards, with EDC /CDISC if required.

NDA application turned down? Quantics has extensive experience of direct consultations with regulatory authorities about statistical aspects of NDAs. We can re-analyse / provide additional analysis  and interpretation of your data to maximize your chances of NDA acceptance.