Today’s challenges in managing clinical studies
As pharmaceutical, medical device companies and Clinical Research Organizations (CROs) manage increasing amounts of clinical information, ensuring data integrity and compliance with regulatory standards is becoming more important than ever.
While Medrio does support paper and hybrid studies, managing studies using only paper is time-consuming, costly, and results in a higher likelihood of inaccurate or incomplete study data.
- Outdated and environmentally unfriendly. As of 2004, over 75% of clinical trials were still conducted using paper data collection as the primary tool. Approximately 28,860 trees are required to support the amount of paper for US-based studies in a year and approximately 20 barrels of oil would be needed to transport this much paper 100 miles.
- Slow and inefficient. The time and effort required to chase paper CRFs, enter data manually, and manage discrepant data is inefficient, often resulting in inaccurate study data. Clinical trial management, therefore, is slower to react to flaws in the processes or protocols that are negatively affecting data.
- Lack of security. Paper processes offer little in terms of protection of patient information, regulatory compliance, and security.
Traditional installed Electronic Data Capture (EDC) offers a unified database but requires a large amount of IT resources, a team of programmers, and ongoing (and costly) maintenance.
- Expensive. Enterprise EDC software requires expensive front-end costs for licensing, but also requires ongoing maintenance fees and upgrade fees.
- IT resources required. Significant IT resources are needed for proper planning, training, storage of servers, and support. It might take months or more for traditional installed EDC to be ready for use.
- No control. With traditional installed EDC, clinical study managers must work through programmers in order to control every aspect of their study.