Solution for IIS Management

Industry collaboration with academia on the research with or without company drugs within or outside the approved product license or before marketing authorization transformed into independent Investigator-Initiated Studies (IIS). Companies may consider requests to support such trials in the form of drug product, comparator drug or/and financial resources without taking the role of sponsor as defined by the ICH-GCP.

While being a non-industry source of data IIS has greater weight in comparison with Pharma R&D sponsored clinical trials. However, it is questionable if the data from IIS can be used for regulatory submissions since these studies usually are not monitored according to SOPs and per ICH-GCP standards. Moreover lacking the access for the IIS direct management companies cannot influence the milestones of the trials. Both data quality and vague trial deliverables markedly reduce Pharma's interest in support of IIS.

GuruMA is acting as an independent shared service provider to the conventional Pharma and Biopharma industry capable to secure the deliverables and monitoring of IIS according to ICH-GCP and company SOPs.

From the side of independent Investigators, the execution of the sponsored trials often faces the limitations in drug supplies and the funding from the industry. In contrary to satisfaction on being independent researcher the functions such as medical writing, start-up, monitoring, data management, and statistics are often the obstacles limiting the overall success of the scientific idea. 

GuruMA is capable to negotiate the IIS idea with industry on behalf of the investigator and to delivery full scope ICH-GCP regulated clinical operations for IIS.