Clinical Data Integration

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Harmonize code lists, structures, and derivations for reliable results.

The main purpose of the GIDB is to support:

• Regulatory responses and submissions with fast turnaround to lead to approval in the shortest time
• Manuscripts and conferences abstracts and presentations
• Marketing promotion materials
• Analyses for payers to secure insurance reimbursement
• Annual safety updates and investigator’s brochure updates
• Pharmacovigilance and safety surveillance to maintain the ability to respond to emerging safety questions that will invariably come from external medical researchers and practitioners.
• Product life cycle planning
• Meta-analyses to understand competitive positions for efficacy
• Exploratory analyses to generate hypotheses for future trials or help optimize designs and identify populations of future trials
• Data mining, including signal detection

Although building a GIDB tends to require major investment upfront, it will save significant amount of time and cost down the road for the clinical programs and commercialization.  It will become a significant asset of the sponsor.  In particular, it will allow the sponsor to rapidly address regulatory agency’s urgent requests in a timely matter.  Even a potential saving of a few days toward drug approval will almost certainly recoup the upfront investment given the revenue potential of many drug candidates.