Electronic Data Capture

Clinical Data Management

Using Medidata Rave, PhaseForward Inform and Open Clinica

One of the electronic data capture challenges pharmaceutical and biotech companies face today are within their Clinical Data Management.  The rapid changes and improvements in data management/capture technology can seem overwhelming when you don't have access to dedicated professionals.

Electronic Data Capture tools such as Medidata Rave, PhaseForward Inform and Open Clinica 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 multicenter clinical trials.

The implementation of an electronic data capture 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.

Reference:
Allan, Nick: Training for a Global Clinical Data Management Environment (2007)

Our subject matter experts are prepared to help with:

Our certified Medidata Rave consultants and trained PhaseForward InForm and Open Clinica staff will be able to provide and support your development from project planning through database lock whether on-site or offsite.

Not only we can provide training, including 1 : 1 training but we are committed to delivering quality Electronic Data Capture service to your organization or Clinical Data Management department.