Clinical Data Management (CDM) Services
In 2007, CMC Clinical Data Management Centre (CMC-CDMC) was established in collaboration with World Health Organization CDM / TDR network to support the conduct of clinical data management for clinical trials in compliance with ICH-GCP, FDA and relevant international regulatory requirements. This centre has been audited by WHO and recognized for clinical data management.
In 2013, with support from PATH (Programme for Appropriate Technology in Health), this centre was promoted as Advanced Centre for Clinical Data Management and Training (ACDMC) to build nation’s capacity in clinical research by providing training and facilitating infrastructure for quality data management.
The following is a summary of our data management services
- Data Management Plan (DMP)
- Standard Operating Procedures (SOPs)
- Database Design, Development and Audit Trail
- Data Entry (Single / Double) – Client / Server or Web
- Data Validation and Query Management
- Database Lock and Audit
- Statistical Analyses and Report Writing
Clinical Data Management Tools
Oracle Clinical (OC)
- Oracle Clinical, a Clinical Data Management System for conducting and managing paper and electronic studies.
- Remote Data Capture for conducting and managing Electronic Data Capture (EDC) trials.
- Thesaurus Management System (TMS) for managing dictionaries required for medical coding during clinical trials.
- Proven compliance platform for various regulatory requirements including FDA’s 21 CFR part 11, GCP guidelines etc.
- Ease integration with external systems (workflow, imaging, OCR/ICR, Barcode Systems, additional data collection devices)
- Interface for defining complex validation checks, including configurable online checks, without the need for PL/SQL skills
Promasys (Protocol Management System)
Promasys is an integrated clinical data management and EDC system that brings quality and efficiency to your clinical data capture and data management processes. Promasys offers rich reporting and work flow support solutions, like automatic distribution of subject recruitment progress reports, automatic generation of bar-coded sample tube labels, work lists, data listings and SAS data sets, etc.
Some of Promasys' main features include
- Easy setup of new trials; use templates and recyclable trial design elements
- Paper CRFs, EDC screens, iPad app screens, forms and labels are all generated from the clinical database design
- Build edit checks without programming
- Manual queries and system generated batch queries
- Full audit trail compliant with 21 CFR part 11
- Electronic signatures
- Set & forget access control, dynamic access rights management through the Study Life Cycle