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Aerial View of Waves


Develop Data Management Plan 

Develop Data Edit Specifications

Database Development/Set-up/Programming 

eCRF Development and Set-Up

Lead Database Validation Process

Develop CRF Completion Guidelines

Perform EDC User Acceptance Testing and Training

Oversee Database management/hosting and status reports

Provide Additional training session (if required)

Query Generation

Query Resolution

Adverse Event (AE) Coding

Concomitant Medication (ConMed) Coding

SAEs Reconciliation

Receipt of Vendor Electronic Data

(Randomization Center, Central lab, Reading Center, etc... )

Third Party Data Reconciliation

Database locking and Report

Data export for Client

Provide On-going Data Management  Support 

  • Attend team meetings

  • Advise on data management topics 

  • Attend meetings with partners

  • Produce materials for investor or business development presentations 

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