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
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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
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Reduce business risk by ensuring compliance

  • Keep content secure wherever it’s stored − 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
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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
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The M-Files Impact

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

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

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Satisfy and retain sponsors through faster project delivery, more informed trial status and greater responsiveness to inquiries.

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Reduce business risks through workflows that automatically comply with regulatory and sponsor requirements and permission-based access that prevents data leaks.

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Upgrade quality and continuously improve SOPs while tightening CAPA resolution through automated workflows and alerts.

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Keep employees happy by making routine work less taxing and creating a more fluid work-from-anywhere experience.

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Create growth capacity by enabling CRAs and project managers to manage more projects without adding staff through automation.

Featured Resources

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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.