CLINICAL DATA MANAGEMENT




  CLINICAL DATA MANAGEMENT

Data management is one of the functional parts of the BIOPHICS; our data management team has been involving in several clinical research studies since its establishment in 1999.

BIOPHICS had managed on of the world's largest HIV vaccine trial conducting in Thailand. In this trial, all data management process for over 25,000 volunteers with more than 1.5 million case record forms processed during 7 years study period.  BIOPHICS maintains the primary database of the study in the regulated system compliant to the 21 CFR part 11.

Not only working under regulated environment of 21 CFR part 11, our data management follows the international standards and guidelines including Good Clinical Practice (GCP).  We are a member of Society of Clinical Data Management (SCDM) and a gold member of Clinical Data Interchange Standard Consortium (CDISC).  Our clinical study project team works closely with BIOPHICS Quality Assurance (QA) team.  The QA team is a member of Society of Quality Assurance (SQA).  We have Standard Operating Procedures (SOPs) for all steps required in performing data management tasks.  

BIOPHICS has been collaborating with other institutions in conducting different scale of clinical research studies ranging from PK study, Bioequivalence study, to all phases of clinical trials. We also have experiences in managing data for other types of study including observational studies and disease/drug registry.

 CDM1  CDM2
 CDM3     CDM4

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