A unique, industry-leading quality oversight model
In-house clinical data, quality assurance, regulatory, and risk management teams
All sites and studies supported by centralized, industry-leading quality oversight experts
Unique model reinforces compliance and ensures timely, accurate data delivery
48-hour data entry target; query resolution within 48 hours of generation
Oversight to ensure impeccable trial conduct
Veteran quality teams work directly with site staff, serving as a resource to identify — and leverage — areas for continuous improvement. The teams support all aspects of QA/QC processes to ensure adherence to all applicable FDA regulations, ICH GCP Guidance, state guidelines, industry standards, and Velocity’s own stringent SOPs.
Quality Control
- Reviews 100% of source for the first five participants in studies for early signals of potential errors, variances, deviations, or need for protocol clarifications.
- Specific participants are followed throughout the life of the study as leading indicators of protocol compliance.
- Remaining participant source undergoes QC using a risk-based approach.
- Review of informed consents, eligibility visits, and ACLOA-C standards
- Targeted reviews for missing concomitant medications, AEs/SAEs, and whether primary endpoints are performed (e.g., documentation of diary checks, documentation of safety calls, whether primary endpoint labs are obtained)
- Review of all visits completed by onboarded CRCs for the first 90 days.
Quality Assurance
- Puts participant safety and data integrity at the forefront of all activities.
- Ensures compliance with protocols and applicable guidelines.
- Conducts study start-up training meetings with site staff before enrollment to prevent protocol deviations and equip sites for success.
- Reviews documents at key points in studies; cross-references EDC data with source for certain data points, and reviews monitoring visit follow-up letters.
- Helps identify quality management trends, guide training regimens, and ensure timely resolution of action items.
- Ensures adherence with local, state, and federal guidelines.
- Manages audit-readiness to support any regulatory or supervisory body visit; provides site-focused audit intervention and visit preparation.
- Team includes veteran CRAs, monitors, and operations managers experienced in monitoring, ICH GCP Guidance, and a broad range of therapeutic areas.
Clinical Data
- EDC and source cross-checks; safeguards standardization and integrity of source documents; supports the data handling and quality requirements of clinical trials.
- Team includes an investigator, CRAs, licensed medical providers, regulatory specialists, QA
specialists, and coordinators. - Creates and reviews source documents, collects study information, and reviews subject visit schedules.
- Collaborates with other departments on project management, risk assessment, study start-up, maintenance, and training.
Regulatory
- Supports accelerated study start-up processes and day-to-day site activities.
- Includes embedded and remote specialists that maintain critical clinical trial documentation electronically and on paper.
- Team members frequently travel to sites to train staff and ensure SOP adherence.
- Supports several aspects of audit preparation; dedicated team facilitates FDA audits to prevent disruption to site operations and patient care.
Reinforce your clinical trial quality
Velocity's integrated quality approach sets a new standard in clinical trial conduct. By combining a unique quality oversight model with rigorous quality control and assurance processes, we ensure impeccable trial conduct that prioritizes participant safety and data integrity.
With a commitment to rapid data handling, comprehensive oversight, and continuous improvement, Velocity not only meets but exceeds industry standards, reinforcing every study with timely, accurate, and reliable data delivery.
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