This white paper provides a summary of why Clinical Data Management CDM must quickly adapt to the mounting data pressures in modern clinical trials and discusses the three pillars that form the foundation of a modern intelligent CDM platform that is needed to succeed in an increasingly complex clinical trial world. The clinical data landscape continues to evolve, but the way data is managed reviewed and cleaned has not kept pace with the growth in data sources, types, volume and velocity.
This infographic explores the challenges and proposes a solution to modernize clinical data capture and management. What are your biggest challenges and priorities for clinical data capture and management in your studies?
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Rave Data Management. Rave EDC. Flexibility and Scalability for All Your Studies Rave EDC has the flexibility and scalability to run all your biopharmaceutical or medical device studies, regardless of size, phase or therapeutic areas. View Rave EDC infographic. Read Rave EDC factsheet. Best in Class Data Security, Privacy, and Quality Ensure the security and privacy of your critical clinical trial data and the privacy of your patients.
Purchasing an EDC system can seem like a large investment, but it should save money in the long run. An EDC must be compliant with regulatory requirements. A big one is 21 CFR Part The software should have the technical controls in place to ensure data integrity. To properly maintain an EDC system, standard operating procedures SOPs are essential to ensuring regulatory and organizational policies are met.
Most software vendors are continually developing new enhancements to keep up with changes in the industry. When creating eCRFs, there are design options to choose from that are meant to imitate paper forms. Forms are saved in a library and are often used across multiple protocols. This eliminates the need to recreate commonly used forms and promotes data standards.
When building forms, edit checks can be programmed to help prevent invalid data from being entered. This ensures the values entered meet certain requirements. Data Entry. After a protocol is set up in the system, the data collected is entered into the appropriate forms.
Query Management. An EDC system provides streamlined communication between monitors, data managers and coordinators. Most systems have auto-generated queries and the ability to manually add queries.
All queries need to be responded to and resolved by different roles before the data can be locked. Data Export. Some systems have built-in metrics reporting that offer insights into the progress of a study. Electronic data capture systems have become a very popular tool to use in managing data in clinical trials. An EDC system can help increase efficiency, ensure data quality, reduce the time and cost of clinical trials, and help meet regulatory compliance.
Learn more about Advarra EDC. Tagged in: institutions , sites. Back to Resources. Search for: Search x.
Ready to Increase Your Research Productivity? View All Services. IRB Document Sharing. Get a Demo. Results: We had a Trials funded by academic institutions, government, and foundations were less likely to use an EDC system compared to those sponsored by industry.
Also, larger trials tended to be more likely to adopt EDC. The EDC sophistication scale had six levels and a coefficient of reproducibility of 0. There was no difference in sophistication based on the funding source, but pediatric trials were likely to use a more sophisticated EDC system.
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