Your site is continually looking for ways to be more efficient, effective, compliant, and connected to sponsors, patients, and regulators. Integrated and interconnected eClinical solutions, in conjunction with comprehensive CTMS, is the best way to achieve these goals.
The benefits of integrated eClinical at your site is more than just moving away from a paper-based system. eClinical platforms empower your site to integrate with sponsors and your CRO for real-time document and data exchange and monitoring. Key benefits include:
- Maximizing Site & Staff Efficiency
- Increasing Study Capacity
- Streamlining Sponsor & Patient Connectivity
- Mitigating Compliance Risks
eClinical solutions works with your your site teams, processes and workflows to ensure that data is aligned and compliant across all studies. By integrating eClinical with your CTMS, staff will be able to more easily work within the system and be an active part of ensuring site data is actionable.
A full eClinical solution is typically comprised of eSource, eRegulatory and eConsent components. Keeping track of regulations and compliance is a vital responsibility for clinical trial site managers. By moving your regulatory management process to a digital system, your site can realize greater efficiency, better workflow, and enhanced compliance to 21 CFR Part 11 throughout your company.
What eRegulatory Does
The eRegulatory system eliminates bulky, unwieldy regulatory binders and transports those resources to an easy-to-use digital infrastructure. Digitizing regulatory management lifts the burden associated with keeping track from clinical research staff, regulatory coordinators and other key personnel, freeing them to deal with more important tasks. It also reduces the risk of errors, which can lead to embarrassing, costly problems and reduce sponsor trust.
How eRegulatory Works
The eRegulatory system incorporates important documents, processes and resources in digital form. It puts regulatory reference materials at your fingertips via site computers, eliminating the bulky binders that take up valuable space, cost a lot to archive and can get misplaced during the trial lifecycle. It also automates several processes, which makes tracking easier and reduces the risk of errors associated with manual methods. Increased efficiency and improved accuracy can lead to better results and elevated sponsor satisfaction.
Why eRegulatory Benefits Your Site
Studies show that most sites not currently using digital regulatory management systems are planning to make the move in the near future. Considering the many advantages eRegulatory offers, it is easy to see why clinical trial site managers are choosing a digital system over outdated manual methods:
- Eliminates space-consuming binders associated with paper management, freeing up clinic space
- Reduces redundancy from data being stored in binders and on servers
- Facilitates easier, more efficient management of regulatory processes across multiple sites
- Frees staff from repetitive administrative tasks associated with traditional regulatory management
- Enables regulatory coordinators to monitor systems remotely
- Leads to more accurate collection of regulatory and compliance data
- Saves time associated with collecting signatures and routing documents
- Reduces risk for compliance errors through robust tracking of various compliance facets and reporting capabilities for audit reporting