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Clinical Data Management

ANY TRIAL, ANY SIZE, ANY WHERE - Our flexible frame work is fully customisable with a wide variety of data capture solutions fully integrated to provide real life Study benefits.

Datamatica provides the following Clinical Data Management services:

  • End to End Work flow right from Study setup
  • Electronic Informed Consent
  • CRF Development
  • Data Management Plan
  • Data Validation Plan/Edit Checks specification documents
  • Database Development
  • eCRF completion guidelines
  • Adverse Event Monitoring
  • Coding of Concomitant Medications
  • SAE data reconciliation
  • Advanced Data Checks
  • Query Management
  • Full Audit Trail
  • Data Locks
  • Data Backup and Archival
  • Customized Reports
  • Data Export

Customisable as per study protocol, the systems multi device capability for point of data capture i.e. via the web and web-enabled mobile devices; A configurable framework ready for your trial’s needs, implemented with minimal customisation and cost.

Process

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Trial Design/Setup

Datamatica has significant experience in trial design and setup as per protocol.


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Multi-channel data capture

Our multi-channel data capture solution reduces the costs and time for clinical trials. It’s the way to capture and deliver data from multiple systems with minimal fuss. It allows the user to engage with the trial data on any device at any time for informed decision making.


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Data Management & Validation

Data Management and Data Validation/edit check services:

  • Protocol Development support
  • Creation and Review of eCRF
  • Database creation
  • Data Entry
  • Query Management
  • Status Reports as needed
  • Cleaning and Validation of database
  • Clinical trial Reports
  • Consist of checks on data to assure validity & accuracy of data
  • Validate data against predetermined specifications
  • Primarily used to check efficiency of data unique to current trial

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Adverse Event monitoring and alerts – at point of data capture

Adverse events are monitored, alerted and recorded as per protocol. Our Real- time alert module helps proactively manage the AE’s and SAE’s as required


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Clean data transfer

  • Better real world data capture
  • Detect and Remove all major errors and inconsistencies
  • Accurate and consistent data