Increase Productivity and Improve Control for Life Sciences

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

Tracking

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

Automation

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

Compliance

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