Standard Operating Procedures (SOPs) Designing

SOPs are detailed written instructions for the management of clinical studies.

An important tool to implement GCP in letter and spirit are SOPs for all the tasks that form the basis of a GCP Compliant Clinical Trial.

SOPs should be designed and maintained by each stakeholder involved in the process of a clinical study (including the Sponsors, Investigative sites, Ethics Committees, Regulators, etc.). SOPs provide a general framework enabling the efficient implementation and a performance of all the functions and activities. They may be tailor-made for a particular study.

At Consortium Clinical Research, we make conscious efforts to understand the need of our client and their organizational structure before we design SOPs that would be compliant with the statutory requirements and also ensure that the personnel practicing them would be at ease.

In addition, we ensure that the staffs involved in executing the SOPs designed by us are trained in the SOPs and their relevant formats (attachments / forms) by providing them with hands-on-training (which are routinely the part of the package of the services that we render to our clients, who seek to deploy this particular expertise of ours).