Dec03

A Checklist for Evaluating eClinical Partners

Utilizing improved systems and tools are necessary in the ever-changing clinical trial landscape. eClinical platforms empower your site to integrate with sponsors and your CRO for real-time document and data exchange and monitoring. Key benefits include maximizing site & staff efficiency, increasing study capacity, streamlining sponsor & patient connectivity, and mitigating compliance risks.

When deciding to deploy either a comprehensive eClinical platform or any of the key eClinical tools (eSource, eRegulatory or eConsent,) careful consideration of potential partners is critical given the sensitive nature of clinical trial data. During your eClinical evaluation, ask if potential partners have:

  •  Seamless integration with CTMS
  • Understanding of how to increase the accuracy of data collection
  • An easy, DIY document creation process
  • Ongoing support focused upon solutions
  • The ability to edit the compliance process at any time
  • The ability to capture electronic signatures and/or upload wet signatures
  • Direct recording of patient data into an original or revised record
  • Clear requirements for e-signatures or initials to advance pages on the forms
  • Tools that enable accelerated study startup
  • Capacity to add videos, graphics, quizzes, and FAQs
  • The ability to deploy changes in real time
  • The tools to enable regulatory coordinators to monitor systems remotely
  • Integrated tools that remove the need for unnecessary data intervention
  • Consent paths for Legally Authorized Representatives or witnesses
  • Tools to enable roles and permissions to both limit access to authorized personnel and allow team members to share documents securely as appropriate
  • Encryption, both at rest and in transit, to protect PI
  • Document cycle time reduction methods
  • Secure documents with passwords and remote backup
  • Reporting on enrollment in real time
  • The ability to incorporate data collected from wearables, heart monitors and other devices
  • Robust tracking that reduces risk for compliance errors through various compliance facets and reporting capabilities for audit reporting

 To learn more about how Bio-Optronics’ eClinical and CTMS solutions can elevate your site performance, contact us to schedule a demo or download our 2020 Site Trends Report.

 

 

 

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