Regulatory Capabilities and Compliance
At NWCRC, we streamline the regulatory and contracting process to ensure an efficient study startup. Regulatory document completion begins only after budget and contract finalization, which typically takes 2-6 weeks. Our site offers expedited budget negotiation and can accommodate sponsor-provided budget templates to facilitate rapid approvals.
- No additional committees or approvals are required beyond CTA signing.
- Pre-approval of site fees is not required.
- Regulatory processing time is 3-5 business days once budget and contracts are finalized.
- We work with all central IRBs and do not have a local IRB, which eliminates unnecessary delays and speeds up regulatory approvals.
By maintaining a straightforward and efficient regulatory process, we ensure that clinical trials can be initiated without unnecessary administrative hurdles, allowing sponsors to launch studies quickly and efficiently.
NWCRC maintains the highest standards of regulatory compliance and has a strong track record with regulatory agencies. In 2024, we underwent two FDA audits, both of which resulted in no findings, demonstrating our commitment to protocol adherence, data integrity, and patient safety.
Affiliation
Since the research is critical component of medical education, we are affiliated with local educational medical institute and Universities like University of Washington (UW) and Pacific Northwest University (PNWU).