SOP Development & Review

'Write down what you should do, do what is written down' - is the basic concept which can define a SOP.

   According to the Indian GCP requirements, it is mandatory for the research sites to maintain their SOPs for various processes related to clinical trials. However, very few sites in India actually comply with this norm. But, now, with more robust process of inspection of research sites and with possibility of registration of research sites with licensing authority, it has become important for all research sites to have their SOPs in place for conduct of clinical trials.

Our vast experience of working with sites in various indications and strong knowledge of regulatory requirements make SenseCR an ideal partner to support sites in development and implementation of SOPs.

Our service with respect to SOP development is unique, wherein we do not believe in providing gen-eral SOPs to sites, which they might find difficult to comply with practically. h is important that the SOPs are strictly complied to, and this is only possible if the SOPs are designed considering the following:

Regulatory Requirements
GCP Requirements
Site's Routine Procedures
WE THUS ADOPT THE FOLLOWING METHODOLOGY IN DEVELOPING SITE SOPS:
We also review existing SOPS of sites, Site Management Organizations (SMOs), Contract Re-search Organizations (CROs). Pharrna Companies related to Clinical Research Operations. and assist in improving the same.
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