Good Clinical Practice (GCP) is essential to maintain data integrity when conducting clinical trials while ensuring patient safety. Our consulting services include GCP audits, training, SOP development, and due diligence for effective CRO management. We also support university hospitals conducting novel clinical trial programs by establishing quality systems independent of a CRO. We apply experience spanning a variety of therapeutic areas and company stages, both emerging and established alike.
Partnering with the GXP consultants at Pace® provides you with the expert guidance you need to operate at the highest quality standards. We'll help you produce trustworthy data, giving you the confidence to move forward. We take the time to understand your unique business, project, and methodologies, and then apply our technical skills, professional approach, and meticulous attention to detail to achieve your goals.
Pace® is your trusted partner for GCP compliance. We prioritize understanding your specific business objectives, project goals, and existing methodologies. Our experienced team applies their technical expertise, professional demeanor, and meticulous attention to detail to deliver practical and effective solutions for your regulatory and compliance needs.
Whether you need to perform a gap analysis or design entire quality systems, our services flex to meet your needs. We offer cost-effective partnership opportunities tailored to your budget.
Ensure your operations are aligned with GCP standards through our comprehensive GCP audit services. We perform CRO and clinical site audits to determine the current state of compliance on behalf of sponsors. Our auditors also perform internal audits and provide gap analyses to ensure compliance for instances of regulatory visits.
Following the audit, we provide detailed observations and offer our expertise in remediating any areas of concern. Our support extends beyond identifying gaps to include a thorough review of your Corrective and Preventive Actions (CAPAs). Sponsors can have confidence in their clinical data for New Drug Applications and Biologics License Applications.
Ensure your team is well-versed in GCP guidelines with our specialized GCP training programs. We offer tailored training to meet your specific needs, empowering your staff to maintain the highest standards of compliance.
Showcasing GCP compliance can be challenging as GCP accreditation and GCP certification are not currently available in the U.S., but it may be important to demonstrate readiness through third-party evaluations. Our consultants offer executive summaries to display GCP compliance fit for purpose. With reliable documentation on hand, you can rest assured your operations are prepared for inspection.
Ready to Get Started? Connect with our experts to discuss your regulatory and compliance programs.