Services
CRDE empowers life-science teams to hit their study milestones by combining end- to-end strategic trial management, lean operational workflows and quality oversight.
CRO Selection and Oversight
Fractional project-lead support from protocol synopses to database lock. We map timelines, vendors and risk logs so your study stays on budget and on schedule, without adding head-count.
Elevate your clinical trials with expert CRO selection and oversight, tailored for sponsors running global trials, with specialized expertise in Europe.
Our Services Include:
- CRO Selection: Identify top-tier CROs through a rigorous process evaluating expertise, capacity, and performance history.
- CRO Oversight: Drive success with clear KPIs, risk-based monitoring, and regular reviews.
- Project Management: Streamline timelines and mitigate risks across global sites.
We optimize CRO partnerships, cut costs, and accelerate timelines.
Contact us today to power your trial success!
GCP Site Audits
We offer independent, in-depth GCP site audits tailored to your protocol, therapeutic area, and global regulatory expectations. Our audits evaluate site performance across informed consent, source documentation, protocol adherence, delegation, and investigational product management. With a risk- based approach aligned with ICH E6(R3), we identify deviations, assess data integrity (ALCOA+), and provide actionable CAPAs to ensure inspection readiness. Whether you’re a sponsor, CRO, or biotech company, our audits help you maintain quality and prevent findings before they happen.
Sponsor Quality Oversight Visits
Ensure your clinical trials stay on track with our Sponsor Quality Oversight Visits, designed for sponsors managing global trials, with specialized expertise in Europe. We conduct targeted, high-impact visits to CROs and trial sites, ensuring compliance, data integrity, and performance.
Our Services Include:
- Strategic Visit Planning: Tailor visits to high-risk sites and critical trial phases using risk-based monitoring.
- Actionable Reporting: Deliver detailed findings and corrective action plans post-visit.
- Regulatory Alignment: Ensure ICH-GCP and regional compliance for audit readiness.
With a proven track record in Europe, our oversight visits optimize CRO performance and safeguard trial outcomes. Contact us today to strengthen your trial oversight!
On-Demand Trainings
Elevate your clinical trial expertise with our On-Demand Trainings. Access self-paced trainings covering clinical project managment, GCP audits, clinical monitoring and more. Hosted on our user-friendly e-learning platform, learn at your pace, anytime, anywhere. Boost efficiency and visit our e-learning platform today!
e-TMF audit
A complete, accurate, and inspection-ready Trial Master File is critical to demonstrating GCP compliance. Our TMF audit services help sponsors, CROs, and sites identify gaps, inconsistencies, and high-risk areas before regulators do. We conduct comprehensive reviews of document completeness, versioning, filing timeliness, and oversight documentation, tailored to your SOPs and the latest ICH E6(R3) expectations. Whether as part of audit readiness or post-trial quality checks, we ensure your TMF stands up to scrutiny.
Vendor audits
Ensure vendor excellence with our Vendor Audit services. We conduct thorough audits of critical vendors to ensure compliance and performance in global clinical trials with specialized expertise in Europe. Our audits assess GCP adherence, data integrity, and operational efficiency, minimizing risks. Tailored to sponsor needs. Our actionable reports drive corrective actions.
Contact us today to schedule your vendor audit!
Resource Hub: e-Books and Templates
Free blog posts tackle common clinical ops headaches, while e-books and templates let you implement the best practices.