Services
End-to-end clinical research,
under one accountable team.
From first IND meeting through database lock and submission. No hand-offs between vendors. No surprises in scope.
Regulatory Management
- ▸IND / IDE
- ▸NDA
- ▸510(k) Clearance
- ▸BLA
- ▸PMA / PDP
- ▸Premarket Approval Documentation
Clinical Operations
- ▸Site Feasibility & Qualification
- ▸KOL & Advisory Boards
- ▸Project Management
- ▸Site Monitoring
- ▸Patient Recruitment & Retention
- ▸Medical Monitoring
Data Management
- ▸Database design, setup & validation
- ▸Data Management Plan creation
- ▸External data loading & reconciliation
- ▸SAE reconciliation
- ▸Discrepancy management & DCF
- ▸Database lock — SAS, XML, custom
Biostatistics & SAS Programming
- ▸Statistical Analysis Plan
- ▸Sample size determination
- ▸SDTM / ADaM datasets
- ▸Tables, Listings & Figures
- ▸Pinnacle 21 review
- ▸Define.xml & Reviewer's Guides
Medical Writing
- ▸Protocols & amendments
- ▸Investigator brochures
- ▸Clinical Study Reports
- ▸Regulatory submissions
- ▸Manuscripts & posters
- ▸Patient narratives
Pharmacovigilance
- ▸Safety database setup
- ▸ICSR processing
- ▸Aggregate reports (PSUR/PBRER)
- ▸Signal detection
- ▸Risk Management Plans
- ▸Medical monitoring 24/7
Quality Management
- ▸21 CFR Part 11 compliance
- ▸GLP, GMP, GCP auditing
- ▸Independent data audits
- ▸Regulatory master file review
- ▸Vendor qualification audits
- ▸SOP development
Biomarker Services
- ▸IND-stage biomarker strategy
- ▸Central lab & assay selection
- ▸AI/ML predictive biomarkers
- ▸Companion diagnostic design
- ▸Sample reconciliation
- ▸CSR biomarker sections