Clinical Data Management

Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. CDM has evolved in response to the ever-increasing demand from pharmaceutical companies to fast-track the drug development process and from the regulatory authorities to put the quality systems in place to ensure generation of high-quality data for accurate drug evaluation.

Our qualified CDM team ensures that the trial databases go into production within stipulated timeline and ensure seamless integration of clinical data through synchronized platforms. The data in our platform are entered, submitted and processed as per 21 CFR part 11 compliance. We follow the Good Clinical Data Management Practices (GCDMP) guidelines - a document providing the standards of good practice within CDM published by Society for Clinical Data Management (SCDM).

Our Services include

• CRF design (Paper/EDC)
• Custom-made CDMS tools to suit their operational needs and procedures
• Implementation and training of EDC
• CFR tracking, Data entry and Validation
• Discrepancy management
• Medical coding
• Database lock and archival