New service from early clinical phase drug development company will provide complete data reporting process to pharmaceutical and biotechnology clients
Early clinical phase drug development company Pharmaceutical Profiles has launched a brand new service that will provide complete data reporting process to its pharmaceutical and biotechnology clients.
The data management service - which will use internal resources at the company's state of the art facility - includes all of the aspects necessary to provide quality data to clients in a timely fashion, such as a clinical data handling plan, an error identification process, the physical setting-up of the database itself, data entry and coding and validation.
All data management projects will follow default protocols, though bespoke parameters required by a sponsor can also be incorporated.
Pharmaceutical Profiles's data management team will also carry out a final crosscheck of the data between the clinical research forms and the database to identify any inconsistencies.
Accompanied by all of the relevant documentation, the whole data management process will save sponsors time and money.
The new service will meet the standards of Good Clinical Practice and will also conform to the emerging standards of Good Clinical Data Management Practice and 21 CFR 11, the FDA's directive on electronic signatures.
According to Geoff Charlwood, who heads-up the brand new department, an in-house data management service will improve the company's service-offering: "In bringing this key service in-house, Pharmaceutical Profiles will be able to offer something distinctive from external data management groups - responsiveness," he explained.
"Our staff will be close to the source of the data, ie, the healthy volunteers or patients in our own wards, and will have expert knowledge of the very specialised kind of clinical trials that the company does."
