QST Consultations, Ltd.
QST Consultations, LTD is a full-service clinical research organization founded in 1974 that provides consulting, clinical operations, data management, biostatistics, medical writing, DSMB support and regulatory submission services for pharmaceutical and medical device development. The organization reports support of more than 800 clinical studies and contribution to over 80 regulatory approvals and emphasizes regulatory compliance, data integrity and secure IT infrastructure.
Industries
N/A
Nr. of Employees
small (1-50)
Services
Strategic consulting on clinical development programs, protocol development, statistical methodology selection, endpoint advice, and FDA submission planning.
Preparation and participation in regulatory meetings, strategic briefing preparation, and expert-witness support related to the statistical interpretation of study data.
Full operational support for study execution including site management, monitoring, patient recruitment, safety reporting and FDA inspection preparation.
Design and management of Data Safety Monitoring Boards including charter development, member selection, meeting coordination and follow-up reporting.
Design, build and validation of EDC systems, CRF/eCRF design, edit check programming, data cleaning, coding and database lock procedures.
Statistical consulting and analytical services including SAP development, production programming, QC, dataset production and integrated summaries for regulatory submission.
Strategic consulting on clinical development programs, protocol development, statistical methodology selection, endpoint advice, and FDA submission planning.
Preparation and participation in regulatory meetings, strategic briefing preparation, and expert-witness support related to the statistical interpretation of study data.
Full operational support for study execution including site management, monitoring, patient recruitment, safety reporting and FDA inspection preparation.
Design and management of Data Safety Monitoring Boards including charter development, member selection, meeting coordination and follow-up reporting.
Design, build and validation of EDC systems, CRF/eCRF design, edit check programming, data cleaning, coding and database lock procedures.
Statistical consulting and analytical services including SAP development, production programming, QC, dataset production and integrated summaries for regulatory submission.
Expertise Areas
- Clinical trial management (Phase I–IV and device trials)
- Biostatistics and statistical consulting
- Clinical data management and EDC implementation
- Regulatory submissions and FDA interaction support
Key Technologies
- Electronic data capture (EDC) systems
- CDISC standards (SDTM, ADaM)
- Statistical programming and analysis software
- Clinical trial management systems (CTMS)
News & Updates
Announcement of leadership appointments naming Phil Doren as CEO and Veronica Powell as COO, describing executive responsibilities and leadership transition.
Announcement describing additions to the leadership team and roles for new statistical and clinical hires.
Community participation by QST employees in a Leukemia and Lymphoma Society event.
QST was selected for the Michigan 50 Companies to Watch program recognizing second-stage companies for entrepreneurial leadership and innovation.
Announcement of leadership appointments naming Phil Doren as CEO and Veronica Powell as COO, describing executive responsibilities and leadership transition.
Announcement describing additions to the leadership team and roles for new statistical and clinical hires.
Community participation by QST employees in a Leukemia and Lymphoma Society event.
QST was selected for the Michigan 50 Companies to Watch program recognizing second-stage companies for entrepreneurial leadership and innovation.