Data Management

One-stop service for clinical trial data, covering from managing clinical data collection until generating data analysis report

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One-stop service for clinical trial data, covering from managing clinical data collection until generating data analysis report

For over 20 years, BIOPHICS has been providing clinical data management services in a wide range of study designs and methodology in different scale from a simple survey, disease registry, to all phases of clinical trials. BIOPHICS Data Management team offers tailored concepts across all key therapeutic areas. We combine experience with technology and therapeutic expertise to ensure actionable outcomes and highest quality of the data we deliver.

We provide clinical
data management services for
Data management plan
Database design, setup,
testing & validation
Case Report Form (CRF) design
& development
Edit check programming
and testing
Data entry
Data validation & query management
Data integration
Data preparation for analysis
Reconciliation of external data
Medical coding using industry standard dictionaries (MedDRA® and WHODrug®)
Database lock & database transfer in client’s preferable format
16,000+ Volunteers

Extensive Experience in Clinical Research

Our staff have broad experience running any type of study ranging from small studies to the world’s largest HIV vaccine trial with more than 16,000 volunteers, handling more than 1.5 million CRFs collected during the 7-year study period. We also successfully conducted a COVID-19 vaccine trial with over 20,000 volunteers under emergency conditions and a highly accelerated timeline, contributing to the official regulatory approval of the sponsor’s product.

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Trusted Clinical Data Management

BIOPHICS maintains the primary database of every study in the regulated system compliant with the 21 CFR Part 11. Our data management process follows international standards and guidelines including Good Clinical Practice (GCP) and Good Clinical Data Management Practice (GCDMP). We are a member of Society of Clinical Data Management (SCDM) and a gold member of Clinical Data Interchange Standard Consortium (CDISC).

Validated Data Management System & Regulated Environments:
21 CFR Part 11 compliant
Clinical Data Interchange Standard Consortium (CDISC gold membership)
Standard Data Tabulation Model & Reporting
Standard MedDRA coding & ConMed coding
Customized computerized system for clinical Study management; e.g., AE alert, on-line X-ray image cross-checking