A major role of CTSG is provision of data management support for research studies; from the design of questionnaires and Case Record Forms, data collection and coordination , database development, data quality management, to archival of the data after completion of the study. In addition, we offer advisory and training services in clinical data management to investigators and study staff.
Data Management Systems
Clinical research data is centrally stored at the MORU hub in Bangkok and is primarily managed in MACRO, a web-based clinical data management system. We also develop custom databases to support study operations and for collection of data beyond research studies.
Innovation in Data Collection
Based on the complexity of the study and context
of the study site, CTSG supports researchers in implementing pragmatic
solutions for data collection. Some examples include:
- mobile-based data capture using ODK software in Cambodia, Laos and Vietnam
development and use of biometric systems for identification of study subjects
- integration of barcoding systems with study databases for identification and tracking of laboratory samples
Standards and Compliance
We are committed to applying international standards in the studies we run. Some initiatives include implementation of a metadata system based on CDISC standard and medical coding using MedDRA®. Clinical trial data is collected and managed following guidelines of Good
Clinical Practice and in accordance with FDA CFR Part 11 requirements.
Our focus is also to build capacity in data management and clinical trial conduct in the region through the use of intuitive and scalable technology for data management, implementation of Standard Operating Procedures, continuous and rigorous training and finally through encouraging engagement and interest.
Learn more about the crucial role data management plays at MORU in this podcast featuring Naomi Wathira, Head of Data Management at MORU.