Unlock Profit and Growth While Reducing Risk

Improve productivity, quality and profitability for contract research organizations with better document management.

Tracking

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‚Äô primary operational interface
  • Increase project win rates by tapping into knowledge from past studies to enhance RFI and RFP responses

Automation

Automate documentation of SOPs and CAPAs

  • Automate SOPs and Resolve CAPAs efficiently through programmed workflows and alerts that provide visibility to deviations from the standards
  • Meet schedule milestones in conformance to 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

Compliance

Reduce business risk by ensuring compliance

  • Keep content secure wherever it’s stored ‚ąí make sure every document is only available to the right people
  • 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

Collaboration

Strengthen sponsor relationships through collaborative workspaces

  • Ensure regulatory conformance by tracking when physicians at investigative sites receive, open and act on critical communications
  • Avoid project delays through life science organisations/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
Tracking
Automation
Compliance
Collaboration

The M-Files Impact

Up to 270% return on investment with low cost of initial entry and fast time to value.

Improve profitability when clinical research staff and project managers are more efficient in everyday work.

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.

Featured Resources

See M‑Files in Action

Seeing is believing. Schedule a demo to learn how to give your CRO a competitive edge by automating processes, enforcing information control and improving sponsors’ experience.