Design and development of both electronic and paper-based case report forms using CDISC CDASH standards, therapeutic area standards and controlled terminology
Preparation of CRF completion guidelines
Data management plan creation
Generation of the data validation plan (definition of edit checks and checks necessary for medical review)
Single or double data entry with third party arbitration of discrepancies
Data cleaning/query management
Regular quality control through database audits for paper-based studies
Import of external data
Medical coding according to MedDRA, WHODrug, ATC
Preparation of SAE reconciliation Plan
Serious adverse event reconciliation
Database lock
Creation of CDISC SDTM datasets, define-XML v.2.0, reviewer’s guide
Database delivery in SAS® transport format, Dataset-XML v1.0, or other formats
