PLATFORM BASED

PROTOCOL

arivis5D-protocol

 

arivis’ electronic Trial Master File solution - arivis5D Protocol - enables sponsors, investigators and CROs to easily demonstrate compliance and control over their clinical document processes. arivis5D Protocol for eTMF allows internal and external staff to securely review, audit, inspect, and search TMF documentation from any location in accordance with ICH and 21 CFR Part 11 guidelines.

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eTMF and Archiving

To comply with regulatory government policies, clinical research organizations need to keep records of essential documents that are stored in the trial master files (TMF). The TMF allows independent auditors and regulatory authorities to monitor and evaluate the quality of the data produced by a clinical study.

HIGHLIGHTS

  • eTMF integration
  • Archiving
  • Actual document statuses and updates
  • Fully integrated with CTMS workflow events and triggers
 

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SOP Management

Life science organizations developing or manufacturing pharmaceutical products will typically create, maintain and execute large amounts of standard operational procedures (SOP). The solid change control and deployment of SOPs are a fundamental to achieve compliance excellence.

HIGHLIGHTS

  • Document-, asset- and project management
  • Operations and oversight
  • Collaborative review for submissions and correspondence.
  • Automation and quality workflows

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CRO Collaboration

The last few years have seen tremendous consolidation in both the pharmaceutical and contract research industries. The impact among pharma companies has created a heightened demand for productivity.

HIGHLIGHTS

  • Controlled assets and documents
  • Collaborative platform for regulated content
  • Processes and end-to-end compliance
  • Workflows along the complete life sciences life-cycle.

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Deviations Management

The management of deviations is not just a GMP concept, it spans the entire product life-cycle, including Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) and Process Deviation Management.

HIGHLIGHTS

  • GMP Deviatios
  • Clinical Protocol Deviations
  • Protocol Deviation Reporting
 

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Trainings Management

Post implementation training services relate often to process changes. With arivis training services implementations are ready for success. The arivis5D Learning Management System (LMS) typically handles the processes related to ramp-up and adoption planning after larger implementations.

HIGHLIGHTS

  • Upload content
  • Deliver courses online
  • Onboarding process
  • User Enrollment, Learning plans
  • Ramp-up new users
  • Tracking and assessing learner performance
 
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