Pages

Clinical Data Management (CDM) is a Technology Perspective which
deals with the management of Clinical trials data from its collection to
its extraction. The extracted data is provided to the Statisticians
and/or Clinical analytics for review and analysis, which is eventually
used to prepare a regulatory submission Report.

Clinical data management is a fast-growing business that offers
pharmaceutical, environmental, food and health industries, research and
biotechnological companies high quality products and services. Using
advanced technology, these data are stored, manipulated, checked for
errors and audited to meet the demands of clients.

The clinical trial data gathered at the investigator site in the Case
Report Form are stored in the CDMS. To reduce the possibility of errors
due to human entry, the systems employ different means to verify the
entry. CDM allows the user to perform Data capture, Data cleaning, Data
reporting, Data extraction and data storage in a backend Databases such
as Oracle, MySQL, Access, SAS datasets, indexed data (legacy data) or
even Microsoft Excel spreadsheets.

Tuesday 25 September 2012

General Services with Clinical Data Management

Protocol review
Data management plan
CRF designing, annotation, completion guidelines
Data validation guidelines
Data entry guidelines
Edit check specifications
Database design, build and test
Edit check programming and testing
Data entry (Single and double data entry)
Data validation and Query management
Coding services: Adverse event/Medication and laboratory
Quality analysis
Database lock and transfer
Generation of data listings
Database freeze and Transfer