Data Management:

• CRF Designing, Review & Printing (Paper CRF)
• Electronic data capture (EDC) using electronic case report forms (eCRFs) implementation
• Preparation of Data management plan (DMP)
• Designing of Database, set-up and Validation
• External data entry into CRFs (eg., Central Lab data & any other sponsor specific data etc)
• Independent Double Data Entry & reconciliation
• Randomization system
• Data validation includes edit checks and query generation
• Medical coding using MedDRA ® / WHO DD ® or any sponsor specific valid dictionaries
• Quality Control
• Data Review
• Database lock