Ardent Clinical Research Services provides end to end comprehensive clinical data management services to the clients from Data Management Plan to Database Lock. The team works on a robust portfolio and strives to ensure the highest quality.

Clinical Data Management Services Include :

  • Project Management.
  • CRF Completion Guidelines.
  • Data processing through double data entry.
  • Safety Data Management & Reconciliation.
  • Provide Software’s to the Hospitals.
  • Data Management Plan (DMP) development.
  • Database Build & Design.
  • Query Management.
  • Data Export/Transfer.
  • SAS Programming and statistical Analysis
  • CRF/eCRF design and development.
  • Data validation specifications.
  • Medical Coding.
  • Data Export/Transfer.
  • Support of Phase I to post-marketing trials.

Key Features of Source Transcript :

Customized & reliable Data Management for integrity, accountability & speed from database-build to database-lock by using our Own software “SOURCE TRANSCRIPT”

  •  US FDA 21 CFR Part 11 compliant Validated System

  •  High System Scalability

  • Study Documents Repository.

  • Customized Reporting & Dashboards

  • Multiple Data Extraction Formats

  • Randomization system set-up/IWR Randomization system

  • EDC/RDC or paper data-capture (e-CRF design & development)

  • Database set-up (design, development and validation)

  • Double Data-entry

  • Data-validation specifications

  • Medical Coding of events & medications

  • Coordinated clinical data cleaning & QC’s review

  • AE-reconciliations (in paper and EDC systems)

  • Integration and transfers of external 3rd party data

  • Database Lock

  • The application development is using ASP.NET and MS.SQL data base system

  • The application is hosted on a secured windows flatform with appropriate securities for access to relevant stake holders.

  • HostGator server which is located in Texas USA having auto back up.


Biostatistics and Programming :

  • Regulatory statistical consulting

  • Study design

  • Sample size estimation

  • Randomization scheduling

  • Statistical analysis plan

  • Statistical programming

  • Interim analysis support

  • Generation of tables, listing and figures

  • Provide complete support in CSR, ISS/ISE preparations

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