The pharmacy Industry has entered the “enterprise era” of electronic technologies for clinical development. Virtually all their clinical trials use electronic data capture (EDC). As Electronic medical records (EMR) become more prevalent in offices, Clinics and hospitals; clinical sites and sponsors work towards integrating the collection of clinical trials management and EMR data.
There are two ways in which this can be done:
Via Database Transfer
From each site, the data from an EMR is extracted and transferred to a clinical trial data base. Since this method involves the mapping of database from one system to the other, sites have to first agree to share their data with the central database created for the clinical trial. Privacy issues of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) also create challenges making this a very unlikely approach.
Via Content Labeling
This is the preferred method, the transfer of data through a shared data content labeling standard is used for this method. The Clinical Data Interchange Standards Consortium (CDISC) has developed standards for data interchange and archiving. Using a transactional approach, data would flow from the EMR into an electronic data capture (EDC) system, or vice versa by using either the CDISC or HL7 standards.
The EMR is a highly flexible system designed to accommodate the collection of data from patients with virtually any health problem, at any time. In contrast to this a clinical trial data collection is more highly structured because its intent is to capture specific information, for a specific purpose, at specific times.
Since a clinical trial system may encompass a number of EMR systems but can only be connected to only one clinical trial data system, its more easier, if the data flows from the clinical trial data system (collected by EDC) into the EMR. If the flow of data were in the opposite direction, then each EMR system would require built-in case report forms and the capability to transmit the data to a suitable location in the clinical trial data system.
The Road Ahead
Eventually Electronic submission requirements for clinical trials data will become so pervasive that they will create a competitive threat for companies whose enterprise technology does not met the challenge.
With years of experience in successfully providing Custom Healthcare Software Development solutions for clients across the globe, we at Binary Spectrum have honed our processes and skills to cater to your specific business needs.