CROs Increase Productivity and Improve Control Through Accessibility and Automation of Documentation
Handle mountains of clinical trial data with more control while improving the experience for field staff, project managers and sponsors.
Unlock Profit and Growth while Reducing Risk
Improve productivity, quality and profitability for contract research organizations with better document management.
Ease tracking of information throughout clinical processes
- Enhance field experience by streamlining tedious documentation tasks so CRAs and project managers can focus on the science of the study
- Ensure document quality through consistent application of master data and alerts that warn of missing information
- Get more from your CTMS by making documentation readily accessible through your staffs’ primary operational interface
- Increase project win rates by tapping into knowledge from past studies to enhance RFI and RFP responses
Automate documentation of SOPs and CAPAs
- Automate SOPs and resolve CAPAs efficiently through programmed workflows and alerts that provide visibility to deviations from standards
- Meet schedule milestones in conformance with SOPs through review workflows, timelines, reminders, and notifications of delays
- Control quality with workflows, security controls, records management, and approvals automatically implementing your policies
- Increase growth capacity by automating routine tasks so your firm can handle more studies without staff additions
- Improve CRA recruitment and retention by equipping them with tools that reduce their administrative tasks and create more time for science
- Accelerate staff onboarding through templates and workflows that enable them to quickly execute SOPs and handle CAPAs
Reduce business risk by ensuring compliance
- Ensure content security by making documents and data sets available to the right people no matter where or by whom they are stored
- Improve blinding by ensuring that users have zero data visibility unless and until they are identified as approved for access
- Provide evidence of operational oversight that inspires confidence in sponsors and meets regulatory requirements
- Maintain Trial Master Files in conformance with regulatory requirements through automated SOP execution
- Streamline audits by showing SOP and CAPA controls and record-level tracking of how and when data was generated, approved, and accessed
Strengthen sponsor relationships through collaborative workspaces
- Centralize sponsor communications, including inputs, outputs, reviews, and collaborations in a single, secure workspace per project
- Ensure regulatory conformance by tracking when physicians at investigative sites receive, open, and act on critical communications
- Avoid project delays through CRO/sponsor workflows, alerts on open tasks, and the ability to collaborate on information in real time
- Avoid losing clinical data that might be overlooked by ensuring version status is not incorrectly coded or miscommunicated
- Track information exchange between investigative sites and sponsors, including acknowledgement of receipt
The M-Files Impact
270%+ return on investment with low cost of initial entry and fast time to value.
Satisfy and Retain Sponsors
Through faster project delivery, more informed trial status, and greater responsiveness to inquiries.
Reduce Business Risks
Through workflows that automatically comply with regulatory and sponsor requirements and permission-based access that prevents data leaks.
Upgrade Quality
And continuously improve SOPs while tightening CAPA resolution through automated workflows and alerts.
Keep Employees Happy
By making routine work less taxing and creating a more fluid work-from-anywhere experience.
Create Growth Capacity
By enabling CRAs and project managers to manage more projects without adding staff through automation.
Improve Profitability
When clinical research staff and project managers are more efficient in everyday work.
See M-Files In Action
Seeing is believing. Schedule a demo to learn more about simplified search, automatic workflows, intuitive user interfaces, and built-in integrations with existing applications and file systems.
