Clinical Data Management

What Is Clinical Data Management?

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. These products and services vary based on the specific needs of the company.

Many companies under the clinical data management industry offer almost the same type of products and services which could differ mostly in the specific needs of their clients. Some companies focus on research and development needs, while some require comprehensive service to accompany their own resources.

As a definition, data management is the development and implementation of policies, procedures, structural design and practices that control the complete data lifecycle requirements of a business; businesses like the above mentioned industries for that matter.

Clinical data management companies utilize a system in clinical research to manage clinical trial data. Using advanced technology, these data are stored, manipulated, checked for errors and audited to meet the demands of clients.

Here are some of the products/services that clinical data management companies offer their clients:

Adverse Event Monitoring- Monitoring of clinical trials and adverse event data processing are done specifically on client’s needs. These data are submitted to the FDA and EC under strict compliance.

Clinical Study- Under the guidelines established by the FDA, clinical studies are conducted as per client’s clinical trial requirements. Safety and compliance to the regulations are observed all the time.

Clinical Data Entry- The most common service for all clinical data management companies is the double data entry. This could be done manually or electronically, depending on the needs of the clients. Under the compliance of the clinical regulations, the CRF images are accessed securely and double data entry will proceed.

Data Collection- Completed forms like DCFs (data clarification forms) and CRFs (case report forms) from clinical trials are sent to the clinical data management company for data entry. Actual pages are verified manually and confirmed before scanning the forms into electronic images.

Clinical SOP- Clinical data management companies provide this service to clients in compliance to the industry’s requirements and demands. In-house clinical SOPs are a must for companies that follow strict guidance.

Data Cleaning and Inquiry Handling- This could be done using the client’s own clinical data management system. Systems such as Oracle Clinical and other EDC systems are commonly used in this case.

Medical coding, data transfer, inquiry generation, database update and validation are some of the sub-services included in this service.

Database Design and Conversion- This can be done by either utilizing the specs and naming requirements of the client, or by using the company’s SOPs.

Dictionary Coding- Clinical data entries are coded into dictionaries that allow specific match-ups and look-ups when data is retrieved.

Programming Solutions- Some clinical data management companies offer programming solutions for time studies, statistical analysis and cost reduction processes.

Reports- Statistical and case reports generation are done under the client or the clinical data management company’s SOPs and protocols.

Tracking and Indexing- Clinical data companies may provide DCF or CRF indexing from scanned forms and vice versa, to their clients. This could be done through internet-based tracking systems which allow clients to access.

The tracking system may be used to generate custom-made reports and track data entries while the work is in progress.

Quality Assurance- Clinical data management companies offer QA services that ensure a close to 100% accuracy based on the client’s standard operating procedure. MEDDRA, COSTART, WHO Adverse Events, ICD-9 and Concomitant Medications are some of the industry’s accepted standard dictionaries for clinical data management.