DATA MANAGEMENT

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 :

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