One of the challenge pharmaceutical and biotech companies faced today within their Clinical Data Management is the rapid changes and improvements in data management/capture technology.
Electronic Data Capture tools such as Oracle InForm and Medidata Rave allow for obtaining large sample sizes with reduced unit costs through global access, fast interaction, and automation. They provide a fast and easy avenue for the acquisition of scientific data, and this method of data acquisition will become much more common place in future multi-center clinical trials.
The implementation of EDC system eliminates the need for double-key data entry as the system automatically checks for inconsistent, illogical or missing data. In EDC, most of the data management planning and implementation are completed even before data entry is initiated. The annotated CRF, database design, and the vast majority of edit and logic checks are finalized prior to enrolling the first subject. The CDM can now look at the data in real-time, and begin the generation of data listings and identification of potential problems early during the course of a study. Training for CDMs in this new global environment, must accommodate this change in technology and shift in the clinical data management paradigm.
THE GOALS OF GLOBAL CLINICAL DATA MANAGEMENT
- Provide Electronic Translation Solutions: Developing translation software to transform data reliably from a variety of sources into a standard readable format.
- Develop Data Management Standard Operating Procedures (SOPs): Following Good Clinical Practices (GCP), and GCDMP in a standard way on a global scale.
- Verify Data for Protocol Compliance: Global standards in assessment of all image and non-image data to ensure proper display format, data integrity and conformance to protocol in accordance with FDA (and/or other) regulations.
- Develop Global Standards in Archiving of Original Data & Back-ups: Provide archive solutions based on the size and type of data sets involved in the trial and the sponsor’s needs. Utilization of a secure on-site data storage facility to house electronic backups of all trial data in compliance with GCP disaster recovery requirements.
- Track Patients and Workflows: Training of Research Associates to electronically monitor all trial data workflows. Providing the sponsor with access to this workflow via a secure link (web interface).
- Provide Sponsor with Electronic Access to Database: Providing sponsors with access to trial data via a secure link (web interface).
- Create Database of Data Analysis Results: Extraction of trial data and submission of it in sponsor-specific database formats.
- Digital FDA Submission: Digital databases of images, reports, and analysis should be suited to be submitted electronically (digitally) to the FDA (and/or other regulatory agencies).
- Timely Transfer of Data to Sponsor.
Allan, Nick: Training for a Global Clinical Data Management Environment (2007)
Our certified Medidata Rave consultants and trained InForm staff will be able to provide and support EDC development from project planning through database lock whether on-site or offsite.
Not only we can provide training but we are committed to delivering quality service to your organization or CDM department.
RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.
The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union. For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.