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Clinical Data Management

Clinical Data Management is designed to deliver what sponsors value most: clean, reliable, and submission-ready data. Our approach begins with clearly defined data collection objectives and focuses on identifying critical data points early, followed by disciplined execution, continuous review, and seamless integration across data sources.

As a global CRO with Clinical Data Management services, we support studies across phases and geographies ensuring clinical trial data is accurate, consistent, and available in real time to support informed decision-making and study oversight.

Comprehensive Clinical Trial Data Management

Our Clinical Data Management services are delivered by experienced teams who work in close coordination with Clinical Operations, Biostatistics, Medical, and Safety functions ensuring alignment from study start-up through database lock.

Study Start-Up

  • Input into protocol data management sections
  • Development of Data Management Plan (DMP)
  • CRF design and development
  • CDASH-compliant CRF annotation and review
  • CRF completion guidelines
  • Database design and build
  • Validation and edit-check programming
  • Identification of critical data points to support focused validation and review
  • User Acceptance Testing (UAT)
  • Quality control checks
  • User training and database go-live

Study Conduct

  • Site team training on study databases
  • User access management and IT support
  • Data entry (including double data entry for paper CRFs, where applicable)
  • Query and discrepancy management
  • Medical coding using MedDRA and WHO-DDE
  • Local laboratory data management
  • External data integrations and reconciliations
  • SAE reconciliation
  • Manual data listings review
  • Customised study metrics and reports
  • Ongoing quality control and targeted data review

Database Lock & Close-Out

  • Database freeze (soft lock)
  • Data transfer to SAS platform
  • Data review and QC in collaboration with Biostatistics
  • Database lock (hard lock)
  • Data archival
Clinical Data Management

Platform-Flexible, Technology-Enabled Solutions

DiagnoSearch delivers platform-flexible Clinical Data Management services, with teams experienced across multiple industry-standard clinical data management systems. Database platforms are selected based on study phase, protocol complexity, number of sites, and data integration requirements ensuring technology choices are aligned to study needs.

Our experience includes

Oracle InForm
InForm based trials are designed and validated in local environment in our Central Designer platform before being hosted on a secure cloud, managed and regulated by Oracle. 
Oracle RDC
Enabling centralized data management for EDC and paper CRF-based trials 
Electron
A validated, 21 CFR Part 11-compliant data management system supporting both EDC and paper CRFs. Electron gives us an edge in completing complex configurations for even the most expansive data sets in a timely and cost effective manner due to its unique database design and support of our in-house development team.   
Wide-Angle-Insights
A fully integrated, source-agnostic clinical data review environment that enables centralized, real-time visibility across clinical, safety, and operational data, supporting timely insights and decision-making  

The DiagnoSearch Advantage

  • Proven Clinical Data Management services with a consistent track record of achieving clean data within planned timelines
  • Robust SOP-driven processes aligned with global regulatory and data standards
  • CDASH-compliant CRF design and standardized global libraries supporting faster database build and go-live
  • Experienced teams with a deep understanding of data flow, mappings, and integrations
  • Close collaboration between Data Management, Biostatistics, Medical, and Safety teams
  • Flexibility to support multiple platforms like Oracle Argus and Wide-Angle-Insights, with a strong in-house IT capabilities
  • Risk-aware data management practices embedded across study design, conduct, and close-out
  • Broad therapeutic and phase experience across global studies
  • Oracle’s preferred Service Provider in the region.

As a trusted Clinical Data Management company, DiagnoSearch delivers Clinical Trial Data Management services that support confident decisions, efficient submissions, and successful trial outcomes.

Connect with DiagnoSearch to explore
how we can support your next study.

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