M-PharmaDigital Clinical Trials

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Any new drug or its modification needs to undergo a clinical trial that shall indicate efficacy and usefulness of the drug for a given ailment. Typical ratios indicate that one out of a 100 prospective drugs survive these tests, and that a billion dollars or more can be spent, with little to no guarantee that the drug shall be approved.

While the odds of the drug being finally approved for human consumption has gone down, the complexity of the trials have actually increased, thereby providing added work and perhaps also reducing the chances of success of the drug. According to the Tufts Center for the Study of Drug Development, the Unique Procedures per Trial has gone up by 46% in a seven year period between 1999 and 2005, during which time total procedures have increased from 96 to 158 and staff burden from 21 to 35 while the length of the trial has gone from about 460 days to 780 days (a 70% increase). These and other factors increase documentation load, which can run into millions of pages of trial documentation.

Added to this are several other complexities such as

  • Trial Result Complexity - wherein results obtained by the same organization between different sites exhibit different results. This can occur due to a number of reasons, part of which might be explainable though design of experiment, part through selection of trial candidates and part through demographics, etc.
  • Document, and Results Manageability & Traceability - with thousands of documents being generated by hundreds of researchers and doctors, it is important to be able to track and retrieve documents, annotate them, and even graph results, create additional reports and circulate them for any number of purposes, save and archive them, as the need be.
  • When clinical trial data is captured in different formats, varying from site to site, and from one investigator to another, the difficulty in comparing documents becomes a major issue, especially when large numbers of documents are to be reviewed.

Trial Master File : reflects a present trend in the area of clinical trials, wherein the master files are presented with standardized formats. The TMF references various document life cycle stages and provides a reference framework for what is expected.

Documentation pertaining to the following are addressed in a reference model

  • Trial Management
  • Central Trial Documents
  • Regulatory
  • IRB/IEC and other Approvals
  • Site Management
  • IP and Trial Supplies
  • Safety Reporting
  • Centralized Testing
  • Third parties
  • Data Management
  • Statistics

 MGRM Solution

M-Pharma provides for a comprehensive Document & Content Management System that contains standard, and best practices for clinical trials. The system allows for multi-site, multi-drug trials, across a defined life cycle, thereby making your work of streamlining collection and processing of clinical trials data easy and efficient.

The system can be run independently, by defining various sites, personnel and organization structures, along with defined roles and responsibilities as outlined by the Good Clinical Practices Guidelines.

Trial Master File standards are embedded within the application, allowing for robust document creation & acquisition, sharing, view / comment / extract / redact, and management your electronic documentation. All media formats including medical images, scanned documents, video, multimedia, xml and other are handled seamlessly in the platform.

Documents are managed using the highest level of encryption and electronic signature technology. An added layer security is provided by the OmVcard that provides anytime anywhere access to the specific user enforcing e-Trust at the site of access. MGRM system is perhaps the only system in the world that provides for this very high level of security. 

© MGRM, Inc. 2016