Delivering Accurate Clinical Trial Data using Advanced Technology with Risk-based Clinical Data Management
Techsol provides centralized clinical data management services for Phase I to Phase IV clinical studies across various therapeutic areas with a comprehensive risk-based and value-focused data management plan. We are committed to providing the highest data quality, integrity, and security for our clients in meeting 21 CFR part 11, GAMP 5 and HIPAA requirements. Using industry-leading electronic data capture (EDC) technologies, we provide end-to-end clinical data management support starting from eCRF design to database lock and final study archival.
Our processes and best practices are based on CDISC, CDASH, Controlled Terminology, SDTM, ADaM, Define-XML, and Study/Trial Design Model standards. Our experienced team of clinical data managers and clinical data coordinators are trained on ICH/GCP as well as 21 CFR PART 11 guidelines.