We can provide input on clinical study design, ensure alignment with regulatory requirements, and make connections between your company and vendors. We can also help with post-market follow-up and reporting.
Clinical Strategy and Planning
- Clinical protocol review
- Create statistical plan
- Working with physicians for the next steps in statistical plan development
- CRO selection
- Vendor selection for clinical endpoint related laboratories
- Data Safety Monitoring Board Selection (DSMB) selection
- Clinical Event Committee (CEC) development
- Budgeting
- Data management strategy with vendor selection
- Initiation of clinical trials with project planning and coordination between pre-clinical and clinical
Development of Clinical Study Design
- Physician surveys on clinical needs and medical use
- Pinpoint clinical need and impact on study design
- Study endpoint planning
- Ensure companies are meeting regulatory milestones
- International clinical studies coordination/leveraging
- FDA-PMDA Harmonization by Doing (HBD) studies
Clinical Trial Safety Reporting
- Clinical study report review
- Protocol deviation tracking
- Post-market study design and end-point development
Investigational Product Management for International Clients
- Manage clinical study inventory
- Device accountability
- Track reconciliation reporting
Let’s Get Started
Contact us directly at [email] or submit the form below. Someone from Addwin will be in touch within two business days.