We customise database services based on your needs and preferred processes in all phases of clinical trials and pre-clinical studies

Our services include: 

  • Development of databases based on clients’ Case Report Forms (CRFs) and specifications, with full documentation
  • Transfer and verification of all data from CRFs via double data entry, the resolution of all discrepancies and the establishment of an audit trail by automatically tracking data entries, changes and deletions
  • Validation of data quality and integrity through extensive validation checks customised for each study
  • Loading of electronic clinical laboratory data into databases and bioanalytical data into PK databases
  • Coding of all adverse events, prior and concomitant medications to standard dictionary terms
  • Change control and data security (e.g. encrypted electronic transfer) which are enforced and monitored by strict control protocols
  • Preparation of tables and listings of pharmacokinetic and clinical data from studies for preparation of ICH-Compliant study reports and Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)