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
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.
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).