Data Management

21 CFR 11 part compliant

Our robust data management is at the heart of our service. One Pharma Lab is a data company.

Our team of data engineers and data managers are trained and qualified to meet the Data Transfer Specifications.

All of our systems are validated and backed-up to the One-Drive cloud and are 21 CFR part 11 compliant.

We implement an ORACLE platform for our data mining and storage. All of our data is backed-up in the cloud and in an off-site data repository for duplicity.

Our data is secure and tier three encrypted for ultimate study data security.

Data Services:

  • 21 CFR part 11 compliant and fully validated

  • Real-Time secure cloud-based result reporting portal

  • Database design

  • Data Validation

  • Data transfers (daily, weekly, monthly, quarterly or annually)

  • End of Study Database Transfers

  • Tab, Comma or Pipe delimited data files

  • Unit conversion (International System of Units (SI), or US Customary Units (US))

  • Data Locks

  • Good Clinical Data Management Practices (GCDMP)

  • Full HL7 bidirectional integration with: ORACLE CLINICAL, CLINTRIAL, MACRO, RAVE, and eClinical Suite

  • Clinical Data Interchange Standards Consortium (CDISC) compliant