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.

We have developed our own software called “SOURCE TRANSCRIPT” which is a cloud based EDC system with 21 CFR part 11 compliance which has two different servers.

Clinical Data Management Services Include :

  • Project Management.

  • Data Management Plan (DMP) development.

  • CRF/eCRF design and development.

  • CRF Completion Guidelines.

  • Database Build & Design.

  • Data validation specifications.

  • Data processing through double data entry.

  • Query Management.

  • Medical Coding.

  • Safety Data Management & Reconciliation.

  • Data Export/Transfer.

  • Support of Phase I to post-marketing trials.

  • Provide Software’s to the Hospitals.

  • SAS Programming and statistical Analysis.