Data Management
Ensuring Data Integrity, Transforming Data Into Decisions
Who We Are
Clinical Data Management is an essential component of clinical trials.
It plays a critical role in the success of a clinical trial by ensuring that the data collected during the trial are reliable, accurate, consistent, statistically sound, and of high quality.
This is achieved through various Clinical Data Management processes, close collaboration with various cross-functional project stakeholders, and adherence to local & international regulations and international standards like ICH-Good Clinical Practice and SCDM's Good Clinical Data Management Practices.
What We Do
At SCRI, our team of Data Managers have extensive expertise & experience in Clinical Data Management. Here are the 4 areas we specialize in:
Protocol Review
Guided by the principles of (1) Fitness for Purpose, (2) Quality-by-Design (QbD), and (3) Critical-to-Quality (CtQ), we review the protocol to align its design for data collection and operational feasibility, with the safety of patients in mind. We present practical solutions which will best steer the clinical trial towards meeting its protocol objectives.
Database Design & Build
After designing intuitive electronic Case Report Forms (eCRFs) which minimizes data entry errors, we design and build the study database and optimize it for your protocol requirements. We also implement automated validation rules and robust edit checks, which catch errors in real-time.
Medical Coding
Our team utilises validated international dictionaries such as MedDRA and WHODrug Global, to standardise medical terminologies and drug names in the study database. All data managers in our team have undergone training and have experience to code with either dictionary.
Ongoing Data Monitoring & Oversight
Through the trial lifecycle, we provide continuous monitoring of data quality metrics, site performance, and protocol compliance. You will receive regular status reports and immediate alerts for critical issues requiring your attentions.
Aside from the above specialisations, we also offer end-to-end CDM services for clinical trials. We have deep experiences managing:
Observational studies, interventional trials
Open-label, single-blinded & double-blinded trials
Phase Ib to Phase IV trials
Why Choose Us?
Flexible Engagement Model
Choose from full-service data management, specific task-based services, or staff augmentation to fill temporary gaps. We scale our support based on your trial's needs.
Quality Assurance
Robust processes designed to maintain data integrity throughout the study's lifecycle.
Regulatory Compliance
CDM processes are guided by, and kept up to date with, principles from ICH-GCP.