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DATATRAK ONE

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CTMS natively integrated with EDC, RTSM and eTMF on one platform

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  • Deployment Cloud Based
  • Starting price Custom
  • Free trial Not offered
  • Best for SMEs, Enterprises

What is DATATRAK ONE?

DATATRAK ONE's distinguishing claim is that its CTMS is natively integrated with EDC, RTSM and eTMF rather than connected to them. The distinction matters in clinical research: integrations between separately built systems need validating, monitoring and revalidating after every change, whereas components sharing one platform and one data model do not.

Around that sit the stated goals of simplifying regulatory submissions, increasing monitor productivity and optimising workflow , all downstream of not having to reconcile the same trial across four systems. The platform extends further into eConsent, post-market surveillance and EMR/EHR connectivity, so a sponsor can run most of a study's technology on one stack. Pricing is quoted.

Key Features of DATATRAK ONE

  • Run CTMS natively integrated with EDC
  • Share one data model across RTSM and eTMF
  • Avoid validating integrations between systems
  • Simplify regulatory submission preparation
  • Increase clinical monitor productivity
  • Optimise trial operational workflow
  • Capture consent electronically through eConsent
  • Support post-market surveillance studies
  • Connect to EMR and EHR systems
  • Manage trial design and data management centrally

DATATRAK ONE Pricing

Custom

Custom

Quoted per study portfolio and modules

DATATRAK publishes no pricing. Quotes reflect study volume and which parts of the ONE platform, such as EDC, RTSM or eTMF, are licensed alongside CTMS.

DATATRAK ONE Specifications

Deployment
  • Cloud Based
Billing cycle
Monthly
Desktop
  • Web App
Languages
  • English
Built for
  • SMEs
  • Enterprises
Support
  • Email
  • Phone
  • Training
  • Tickets
Integrations
DATATRAK EDC, RTSM, eTMF and eConsent, EMR and EHR systems
Public API
Yes
Free trial
No
Free plan
No
Runs in browser
Yes
Customisable
Yes
Website
datatrak.com

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DATATRAK ONE FAQs

A unified clinical trial platform whose CTMS is natively integrated with EDC, RTSM and eTMF, extending into eConsent, post-market surveillance and EMR connectivity.

The components share one platform and data model rather than being separate systems connected together, so there are no integrations to validate, monitor and revalidate after each change.

Because every interface between validated systems carries its own qualification burden, and reconciling the same trial across four systems is where operational time is lost.

eConsent, post-market surveillance, EMR and EHR connectivity, trial design and data management, so most of a study's technology can run on one stack.

Pricing is not published. Quotes reflect study volume and which platform modules are licensed alongside CTMS.