Clinical Data Integration
Pharmapace has rich experience of building a global integrated database (GIDB) for a compound with drug(s) on market. GIDB is built to standardize the data code lists, structures, and attributes with ADaM standards, to derive the analysis variables consistently, and to minimize reporting errors and inconsistencies with consistent derivation definitions and dictionaries across the clinical programs for a compound. Once a GIDB is set up it will greatly help unlock the tremendous value of the clinical data that your company has spent a huge amount of money, resources, and effort to acquire over many years.
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.