What We Offer
Arkin Consulting Group offers comprehensive FDA and ISO regulatory, quality and clinical consulting services including:
Clinical Planning, Management & Monitoring
Clinical trials are designed under the requirements of a product’s claims for efficacy and safety. Specific information and testing needs are built into the protocol and data reporting forms developed by ACG consultants.
Planning/Clinical Development
- Advisory Board Charters and Hosting
- Author Case Report Form Guidelines
- Author Clinical Monitoring Plans
- Biostatistical Analysis & Reporting
- Case Report Forms Development
- Clinical CGP Development (ICH/GHTF)
- Clinical Project Management (Kickoff to Submission)
- Clinical Research Unit Design
- Clinical Site Monitoring
- Clinical Strategies
- Clinical Study Size Training
- Clinical Trial Metric Tracking
- Data Safety Monitoring Board Setup
- Electronic Medical Records in Research Process
- Investigator Site Setup
- Pre-FDA/Regulatory Inspection Readiness & Preparation
- Site Monitoring (as a CRA)
- SOP Development for Sponsors and Sites (Pharma & Device)
Product Analysis/Testing
- Business Development
- Product Testing
- Product Packaging
- Third-Party Testing Certifications
Clinical Studies for Devices, Pharma and Biologics
- Specializing in Phase I clinical studies
Training for clinical study participants
- Sponsors, PI/CI, associates/assistants, techs, lab personnel, etc.
Refer to the list of products and clinical specialties we have direct experience with….