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Digital Signatures: Cloud + Digital Signatures == Reduced Costs

By Dick Weisinger

A cloud-based pilot that managed documents related to a clinical trial for drug approval resulted in significantly reduced costs.   The trial was part of the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI/CTEP) and much of the work was performed on a drug trial for Bristol-Myers Squibb.

In the trial, key researchers were provided digital identities and software to enable the digital signing of documents.  The documents used in the trial were stored in the cloud.  A combination of the two technologies provided quick, easy and secure way to access the documents from the cloud-based storage.   Drug trials are notoriously for being a long and expensive process.  The costs of conducting a clinical trial have been steadily increasing and the patent exclusivity periods have been shortened.  The trial showed that the use of  cloud based storage could reign in some of those costs and speed up the process.

A typical drug trial can involve the management of 100,000 pages of documents and numerous mailings and FAXes sent to and from the FDA.  Typically during a drug trial 10 percent of the documents are shipped over night and another 10 percent are sent by courier.  The cloud-based alternative can eliminate much, if not all, of the overhead and cost involved in sending documents.  The time to currently get a signature for a clinical trial document takes 3 to 5 days.

The report cited cost savings in the following areas:

  • Expedited site initiation
  • Reduction in report routing costs
  • Improved audit efficiency
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