Clinical Data Management
Our data management solution is tailored to match trial specific needs. The service comprises of two categories namely the setup and maintenance of an Electronic Data Capture (EDC) database and data processing. These services are offered individually or together to constitute an end-to-end data management solution.
Our experienced team is guided by industry standards such as the Good Clinical Data Management Practice (GCDMP) guidelines and use validated IT solutions to provide data that is accepted by all major regulatory authorities around the globe including the FDA.
We use various EDC systems (21 CFR Part 11 compliant) as the primary data collection and management tools supported by rigorous internal standard operating procedures and other applications such as SAS® to deliver quality trial datasets.
Our key deliverables include EDC database development and data processing.
EDC database development includes:
- The design of electronic case report forms (eCRFs).
- Database design, validation and user acceptance testing (UAT).
- Electronic Patient-Reported Outcome (ePRO) form set up for questionnaires and other diary data.
- Edit check programming and testing to support data processing.
- Integration of Interactive Web Response Systems (IWRS) to support central randomisations. Database deployment to production (“Go Live”).
Data processing services includes:
- Data review, cleaning and reconciliation
- Medical coding of adverse events, medical history, and concomitant medication term.
- External data import and reconciliation.
- Serious adverse event (SAE) reconciliation.
- Custom reports and listings during the trial conduct.
- Database exports during and at trial conclusion.
- Database archival.
Our processes are supported by:
- Data management plan.
- Data validation checks.
- SAE reconciliation plan.
- External data transfer and reconciliation plan(s) for all externally collected data.
- Pre-database lock checklist.
- Trial archiving report.
Our goal is to deliver high quality data with shortened setup, processing and lock timelines for each clinical trial. We maintain data integrity by using systems and processes that are compliant with global regulatory requirements, including ICH-GCP and 21 CFR Part 11.
Viedoc designs engaging software for the life science industry. By accelerating clinical trials on all levels, Viedoc’s solutions support major pharmaceutical, biotech, and medical device companies, as well as renowned research institutions worldwide. Headquartered in Uppsala, Sweden, Viedoc also has offices in America, France, Japan, Vietnam, and China. Since Viedoc’s inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. Discover more at viedoc.com.
Medrio is on a mission to ease complexity in today’s hybrid, decentralized, and site-based clinical trials by delivering a flexible suite of eClinical technologies and services, including EDC, eCOA/ePRO, eConsent, Direct Data Capture, and Randomization and Trial Supply Management (RTSM). Trusted by contract research organizations (CROs), sponsors, and sites across all therapeutic areas and trial phases from study startup and feasibility to post-market approval since 2005, Medrio is industry-recognized for delivering eClinical software with intuitive interfaces and timesaving “drag and drop” configurations as well as high-touch customer engagement, onboarding, and support services. Learn how they do it at medrio.com.