Site Services
The New Paperless
Study eSafe™ provides digital solutions to several challenges facing clinical study sites. Process, organize and store regulatory binder documents and source documents more efficiently. Ensure safety reports and SUSARs are processed more quickly. Track training more effectively. Run Audits more smoothly. Save time, money, and space by using tools like RegDoc eSafe at your site.
Easy to Use
Rapid to Deploy
Most Affordable system available
Designed specifically for Clinical Study Sites, RegDoc eSafe is quick to deploy, easy to use and cost effective. RegDoc eSafe is a validated system that is 21 CFR part 11 compliant and meets the security requirements of pharmaceutical and biotechnology trial sponsors.
Fast and Efficient
- Convenient work flows for regulatory coordinators
- Document version control
- Superior study closeout features
- Rapid document retrieval
- Improved ability to view status and manage completion of all documents
Wonderfully Flexible
- Flexible design allows for folder customization
- Organize the regulatory binders to match your site’s work flow
- Use your site’s standard terminology
Secure and Auditable
- Controlled, role-based access to documents and regulatory binder sections
- Fully reportable audit trail of all document activities
- Secure backup of regulatory binder documents to any location
Cost Effective
- Eliminate the cost and space of paper archive storage
- Reduce time spent scanning, faxing, printing and filing
6,000 Clinical Study Sites use MedPoint Services
We are currently running 40+ investigator portals with over 6,000 clinical study sites participating.
Our experience extends to 6 continents
Benefits of an Electronic Regulatory Binder?
- More efficient
- Less paper costs
- Less hassle wrestling physical binders
- Better use of space
- Easier Access
- Better Compliance
MedPoint Digital has an unrivaled track record of experience and innovation in the global clinical research community. We understand clinical study sites and provide technology solutions that are powerful, practical and reliable.
- 26 years serving clinical research
- 14 years providing clinical trial portals to 3000+ clinical study sites globally
- HIPAA and 21 CFR Part 11 compliant
How we help
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
4. ROI
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.
See how much you save using RegDoc eSafe!
Let us show you how,
“Paperless Can Be Painless™”
www2.medpt.com/site-services/
esafe@medpt.com
877.586.0800