CRF design as per the protocol,
CRF Annotation,
Database Design(creation of the e-CRFs)
Creation of Protocol specific Edit Checks
UAT
Inputs to the Data Entry, MedDRA coding and WHOdrug coding groups.
Data Validation as per the Data Validation Plan
Discrepancy Management,
SAE Review and Reconciliation with the Safety Database,
Creation of the customized reports to verify the data inconsistancies and taking appropriate actions to resolve those,
Cental Lab Data Review and Reconciliation activities,
Data base Lock for further analysis.
Data extraction and creation of the SAS datasets.
Mapping of the data in to client required standard or CDSIC SDTM standards using SAS,
Providing inputs to t...