Designed specifically for the clinical researcher at Research Study Sites and Research Institutions, RegDoc eSafe is a validated, 21 CFR Part 11 compliant eReg system that provides a paperless solution to several challenges facing clinical study sites. Process, organize and store all of your regulatory binder documents more efficiently. Run audits more smoothly and reduce the redundancy. Save time, money and space by using tools like RegDoc eSafe at your study site!
Easy to view high-level overview of your study site’s activities
- Check on total number of binder documents
- Ensure documents are being uploaded in a timely manner
- Check on number of outstanding signature
- Ensure accountability and reliability
Control who see what and when in your eReg Binder!
- Granular control of roles and access across all users
- Assign binders to specific users
- Restrict confidential documents/folders
- Unlimited roles and expansive configuration options
Compliant Part 11 eSignatures
- Fully compliant eSignatures that are accepted by sponsors
- Easy-to-use approval and signature workflows
- Special PI-only view for completing signatures
- Notifications to users when signatures are requested and completed
Access documents from anywhere, at anytime
- Cloud-based platform allows for remote monitoring
- Give your CRA access for a limited period of time
Save money while becoming more efficient!
- Neutral value proposition to study sites!
- Lowest cost eReg solution on the market.
- No hidden fees
- Pay as you go pricing model. Only pay for what you USE!
6,000+ Clinical Study Sites use MedPoint Digital Services
MedPoint has an unrivaled track record of experience and innovation in the global research community. We are currently running 50+ investigator portals with over 6,000 clinical study sites participating worldwide. Our 29 years of experience extends to 6 continents.
Fast and Efficient
Convenient workflows for regulatory coordinators and site staff
Document version control and superior study closeout features
Rapid document retrieval
Improved ability to view status and manage signature completion of all documents
Secure and Auditable
Controlled, role-based access to all documents and folders
Full audit trails of all document activities
Secure, cloud-based backup of regulatory documents
Eliminate the cost and space of paper archive storage
Reduce time spent scanning, faxing, printing and filing
Reduce document cycle time and signature “hunting”
Accelerate Study Startup
Versatile, Intuitive and FAST
Intuitive design allows for quick ramp up with little training
Organize the regulatory binders to match you site’s work flow with unlimited customization folder templates
Use your site’s standard terminology and naming conventions
How MedPoint Digital Helps
1. Rapid Implementation
RegDoc eSafe is designed for fast, flexible configuration, intuitive use with minimal training, and a thorough but streamlined validation process.
- Streamlined implementation process to get your clinical study sites up and running quickly
- Regulatory binder templates pre-loaded into your site for easy access
- User upload and access control configuration
- Admin and user training sessions
2. Software Validation
MedPoint is regularly audited by study sponsors and has long experience developing and supporting validated systems.
- MedPoint is committed to compliance and walks you through the necessary steps to validate our software
- We provide sample validation test scripts and validations plans for execution at your site
- We assist in developing new internal policies or SOPs to ensure compliance
- Our team provides product update release notes to keep policies up to date
3. Superior Customer Support
Our systems are easy and intuitive to use, and we are there to answer your questions.
- Email and phone support
- Online admin and user guides
- Online help center with resources always available
Make technology work for you to save time and decrease costs!
Say goodbye to shelves loaded with 3-ring regulatory binders and rooms full of archive boxes, and say hello to cloud-based storage and digital back-up files.
- MedPoint will work with clinical study sites to help them upgrade to an electronic regulatory binder and reduce overall regulatory binder costs
- Find what can and can’t be reimbursed for by the sponsor.