We begin by working through the study protocol to define your objectives. Anticipating challenges and technology requirements at this early stage allows us to develop a truly customized approach.
Global Experience and Reach
Being based in multiples regions means we’re always able to provide timely support to investigator sites. We’ve previously executed Phase I – IV studies on a global scale in a broad range of therapeutic areas.
We offer technological expertise in running clinical trials on Electronic Data Capture (EDC), Clinical Trial Management System (CTMS) and Electronic Trial Master File (eTMF) platforms and importing data from lab, imaging and Patient Reported Outcome (PRO) devices.
Our data management services include:
- Input during protocol development Electronic Case Report Form (eCRF) design
- Database design and validation
- Electronic edit check programming and validation
- Consulting/training for implementation of new systems, coding and dictionary management
- Creation of new Standard Operating Procedures (SOPs)
- Managing outsourcing to ensure compliance with your SOPs
- With Clinical Research Associates (CRAs): risk-based monitoring and analysis
- With Medical Monitors: assessment of patient safety on an ongoing basis
- Electronic Data Capture (EDC)
- Global cleaning to all required standards: 21 Code of Federal Regulations (CFR) part 11 compliant Clinical Data Management System (CDMS), according to the International Council for Harmonization of Good Clinical Practice (ICH-GCP)
- Coding of medical terms (secondary diagnoses, medical history and adverse events) according to Medical Dictionary for Regulatory activities (MedDRA)
- Coding of medications (previous and concomitant medications) according to World Health Organization Drug Dictionary (WHODrug)
- Ongoing Quality Control (QC) of data including final QC prior to database lock
- Ongoing serious adverse event reconciliation
- Integration of third-party vendor data including Electrocardiogram (ECG) data; central and local laboratory data; imaging data; and PK data
- Transfer of data for statistical analysis and submission to the regulatory authorities, according to Clinical Data Interchange Standards Consortium (CDISC) or client specific standards
Get in touch to find out more about data management.
Clintec’s Data Management Service, combined with Biostatistics and Programming, is an extension of the Biometrics department.