Creating quality SOPs is in DArcy’s DNA. Our SOPs are designed precisely for each Start-Up client – highly tailored to drive efficient and consistent operations. In reviewing clinical SOPs or in developing clinical SOPs, we follow our internal framework for Best Practice SOPs which lays out the foundational elements of good quality SOPs.
We have developed Clinical SOPs for all aspects of clinical trials – planning, conduct of trial and close out of trials. In developing SOPs, we work closely with our clients to understand their internal processes and then draft the SOPs based upon our client’s organization structure, its processes and its vendors. While many Start-Ups will utilize the services of CROs and so will use the CRO SOPs, delineation of responsibilities and accountabilities is critical. Sponsor oversight of its CROs and demonstration of oversight is critical and how this is done is outlined in an SOP. In addition, sponsors still need to have a core set of SOPs that dictate its responsibilities around conduct of the trial. See case study on GCP SOPs.