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Due to Clinical Trial’s increasing cost, complexity, adherence to regional and national regulations, redundant regulatory review process and alteration in technology, pharmaceutical companies are under tremendous pressure to identify opportunities that • Reduce clinical trials cost • Increase efficiency • Improve cycle time • Streamline R&D process Incedo offers a full range of CDM services that can be customized to meet our customer's specific requirements. Incedo is well equipped in performing CDM activities leveraging both Electronic Case Report Form (eCRF) and paper Case Report Form (CRF) processes throughout the clinical development phases. Our services are supported by diverse Electronic Data Capture (EDC) software platforms, exhaustive SOPs, tools and systems. Collection, Integration and Validation of Clinical Data A Multi-disciplinary Activity Clinical Data Management Clinical Data Management Services Our services include a combination of technology and functional expertise by leveraging industry standard tools and technologies to optimize and accelerate CDM activities (trial initiation/set-up to completion phase): • CRF/eCRF Design and Development • Data Dictionary Management (e.g. Med DRA) • Database Design & Set-up • CRF Tracking Set-up • Clinical Data Entry (single and double), Comparison and Adjudication • External Data Loading, Documentation, Archiving and Storage • Lab Data Management • Query/Discrepancy Management • Serious Adverse Event (SAE) Reconciliation • External Data Providers Management • Data Processing and Validation • Database Testing & UAT • Data Record and Regulatory File Management • Data Quality Control • Data Lock and Transfer • Database Closure • Analysis and Reports • Project Closure Clinical Study - Initiation/Set-up Clinical Study - Conduct/Ongoing Clinical Study - Conduct/Ongoing Clinical Study - Conduct/Ongoing CDM Process
