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