Quality and Compliance

All Velocity sites and studies are supported by in-house clinical data, quality assurance, regulatory, and risk management experts.

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.

Shot of a doctor showing a patient some information on a digital tablet

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.


  • 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.


Let's talk about your next trial

Quality. Continuity. Velocity.