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Solution for IIS Management

Industry collaboration with academia on the research with or without company drugs within or outside the approved product license or prior to marketing authorisation transformed to 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 non-industry source of data IIS have greater weight in comparison with Pharma R&D sponsored clinical trails. 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 standard. More over lacking the access for the IIS direct management companies cannot influence the milestones of the trials. Both data quality and vague trials deliverables markedly reduce Pharma interest in support of IIS.

GuruMA is acting as an independent shared service provider to 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 Investigator the execution of the sponsored trials often faces the limitations in drug supplies and the funding from the industry. In the 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.

 

eIIS (will be available soon)

Cloud-based platform merging independent Investigator requests and proposals on Investigator Initiated Study with Companies interest in supporting research on particular therapeutic area or indication.

 

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