About us
Clinical Research & Regulatory Services: We provide end-to-end research and regulatory support, including site feasibility, regulatory documentation, IRB submissions, EDC/eSource support, query management, study documentation, compliance, and inspection readiness, helping studies stay organized, compliant, and on track.
Clinical Research Site Partnerships: We partner with physicians and healthcare practices to build and manage clinical research operations, including study start-up, patient recruitment, study coordination, data management, sponsor/CRO communication, monitoring support, and close-out—allowing physicians to remain focused on patient care and safety
Physicians Lead the Medicine. We Lead the Research Operations
SERVICES OFFERED
Sponsor-Site Partnership Solutions
We connect the right sponsors with the right clinical trial sites to create strong, results-driven partnerships
- Identifying and introducing sites with the right patient population and resources.
- Conducting site feasibility assessments to ensure readiness and recruitment potential
- Guiding sites through onboarding, document collection, and system setup.
- Acting as a dedicated liaison to ensure smooth communication and timely deliverables
Regulatory Affairs Support
Stay compliant with changing regulations and avoid costly delays
- Preparation and submission of clinical trial applications to ethics committees and regulatory authorities
- Expert review of protocols, informed consent forms, and Investigator Brochures for regulatory compliance
- Post-approval management of amendments, progress reports, and compliance updates.
- Continuous monitoring of regulatory changes to keep your trials on track
Clinical Operations Assistance
Practical, hands-on support to ensure your trial runs smoothly at the site level.
- Study start-up coordination, including regulatory green light processes
- Site staff training on GCP, protocol requirements, and trial systems
- Site performance optimization to boost patient recruitment and retention
Documentation & Data Management Support
Secure, compliant, and efficient documentation services that reduce site burden and keep your trial inspection-ready.
Data Management
- Entry of CRF/eCRF data into sponsor-designated EDC systems (Medidata, Oracle InForm, Veeva, REDCap, Green Light Guru etc.) through secure portals.
- Timely, accurate transcription of data from completed source documents or paper CRFs.
- Timely, accurate transcription of data from completed source documents or paper CRFs.
Audit Readiness
- Performing double data verification to minimize discrepancies.
- Generating, tracking, and resolving queries in coordination with sites and sponsors.
- Continuous data cleaning to maintain a high-quality database ready for interim and final analyses.
Get in touch
Our Office
2200 Hopewell Crest Dr, Fuquay Varina, North Carolina, 27526
info@regulatory-nexus.com
Phone Number
+1 919-762-2459