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Clinical Data Management

ANY TRIAL, ANY SIZE, ANY WHERE - Our Flexible frame work is ready to meet your trial's need. We are ready to implement with minimal cost and is flexible to allow customization as per study protocol.

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 Check
  • Query Management
  • Audit Trail
  • Data Lock
  • Data Backup and Archival
  • Customized Reports
  • Data Export

Customizable as per study protocol the system has multi device capability for point of data capture ie via the web and web-enabled mobile devices. A configurable framework ready for your trial’s needs and can be implemented with minimal customization.

Our Process


Trial Design/Setup

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


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. It allows the user to engage with the trail on any device at any time.


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 data unique to current trail


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


Clean data transfer

  • Better data beats fancier algorithms
  • Detect and Remove all major errors and inconsistencies
  • Accurate and consistent data