We work hard to ensure the efficiency and accuracy of your clinical research study every step of the way, from study initiation through data management.
The Bio-Kinetic Clinical Applications Institutional Review Board
conducts review in accordance with pertinent authorities, including but not limited to:
- ICH E6 Good Practice Consolidated Guidance
- US Food & Drug Administration (21 CFR Parts 50 and 56)
- US Department of Health and Human Services (45 CFR Part 46)
- Ethical principals outlined in the Belmont Report
Dedicated Study Planning
For each study that passes through the doors at QPS Bio-Kinetic, we initiate team protocol training, offer individualized source documents, review the study product, perform a "dry run," plan for safety accordingly, ensure a schedule of assessments, and perform a dry run with sponsor oversight if needed.
From study initiation through final report, each step of the data entry process is carefully monitored. Our data entry team completes a full QC and QA of all source documents and electronic case report form entries.
QPS offers its own case report form with offsite access for sponsors via OpenClinica software. Our data entry team has experience with most systems including OpenClinica, InForm GTM, Oracle Remote Data Capture (RDC), and Medidata Rave.
Data Management & Biostatistics
QPS Bio-Kinetic offers a full range of data management through our global colleagues in the QPS family.