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Governance and Collaboration: CTMS Checklist

A recent market research report forecasts that the eClinical solutions market will be worth 5.98 billion (USD) by 2020. With sponsors and CROs adopting new eClinical software, or replacing legacy systems, such as clinical trial management systems (CTMS), vendors are emerging with new software to stake a claim in this growing market.

Key in managing trials, few CTMS systems bring the added benefit of deep visibility supporting governance and collaboration within an increasingly complex clinical trial environment where multiple outsourcing specialists are engaged in different clinical trial aspects.

When evaluating a CTMS, be sure to carefully examine system capabilities supporting governance and collaboration, including:

  • Ease of getting data into the CTMS from provider systems.
  • Visibility into partner performance. (Is the sponsor or CRO able to see who manages a region and sites? Can performance metrics be extracted?)
  • Ability to get performance metrics showing how well all partners are doing in fulfilling their Service Level Agreements (SLAs).
  • Flexibility to accommodate clinical trial operations specific to each trial.
  • Strength as a hub to provide a consolidated view of the data within a single repository.
  • Degree of automation to efficiently and quickly handle vast amounts of data.
  • How different monitoring and outsourcing scenarios are supported.
  • Is there an integrated MVR?
  • How is SAE tracking supported?
  • How robust is on-demand reporting?
  • Is master milestone tracking provided?
  • How is CTMS access and privacy handled?
  • How is permissioning accomplished?

A multi-faceted CTMS will help sponsors and outsourcing specialists improve governance and collaboration, producing a number of benefits, surrounding workflow, information sharing, milestones, regulatory compliance, reporting and submissions.

It's essential that your CTMS' underlying platform supports scalability for your needs and can extend across the global trial network, bringing sponsors and CROs into one common ecosystem. This integrated approach improves visibility into performance and other key data, enabling sponsors ad CROs alike to fully realize the strategic value of outsourcing.

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Governance and Collaboration in Clinical Trials Using CTMS

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