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Clinical Data Management

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Delivering Accurate Clinical Trial Data using Advanced Technology with Risk-based Clinical Data Management

Techsol provides centralized clinical data management services for Phase I to Phase IV clinical studies across various therapeutic areas with a comprehensive risk-based and value-focused data management plan. We are committed to providing the highest data quality, integrity, and security for our clients in meeting 21 CFR part 11, GAMP 5 and HIPAA requirements. Using industry-leading electronic data capture (EDC) technologies, we provide end-to-end clinical data management support starting from eCRF design to database lock and final study archival.

Our processes and best practices are based on CDISC, CDASH, Controlled Terminology, SDTM, ADaM, Define-XML, and Study/Trial Design Model standards. Our experienced team of clinical data managers and clinical data coordinators are trained on ICH/GCP as well as 21 CFR PART 11 guidelines.

How We Help Sponsors With Clinical Data Management

Study Initiation Phase

  • DMP Preparation
  • CRF Designing
  • CRF Annotation
  • eCRF Design and Testing
  • Data Validation Plan Preparation
  • Edit Checks Programming
  • Drafting eCRF filling guidelines
  • Study Database UAT
  • Study Go-LIVE

Study Conduct Phase

  • Clinical Data Validation
  • Discrepancy / Query Management
  • Lab Data Loading
  • Ongoing Quality Control
  • Medical Coding
  • Post-production Change Management
  • SAE Reconciliation
  • Data Management Reports

Study Closeout Phase

  • Outstanding Query Resolution
  • Approved Data Updates
  • Final Medical Coding Completion
  • Perform Blinded Data Review
  • Generate data sets and publish it for final analysis
  • Investigator Signatures
  • Final Quality Review
  • Database Lock and Archive

Let Us Know How We Can Help You