ACADEMIC INSTITUTION

Do you have access to qualified industry experts who develop contemporary regulatory, clinical, policy reform, reimbursement, risk management and quality assurance courses geared toward entrepreneurs, scientists, and business students?

Clinical Research Strategies can help prepare entrepreneurs, scientists, and business students for today’s demands of industry and regulators. Our network of experts can help your faculty integrate timely curricula and case studies. 

Learning modules may include, but are not limited to:

Pre-Clinical Testing
Phase I – IV Clinical Research
Protocol Writing, Design, and Statistical Approach
Clinical Trial Costing and Budgeting
Economic Impact and Reimbursement Objectives
Investigational Device Exemption (IDE)
Humanitarian Device Exemption (HDE)
Laboratory Developed Tests (LDTs)
In Vitro Diagnostic (IVD) Device
Investigational New Drug (IND)
New Drug Application (NDA)
Combination Products
510(k)
Premarket Approval Application (PMA)
International and US regulatory considerations
US Federal Grantors
Good Clinical Practices
Good Laboratory Practices
Good Clinical Data Management Practices
Good Publications Practices in Medical Research
Risk Management
Quality Systems and Design Control
Continuous Quality Improvement
Labeling
Standards and Guidelines
Post-Market Surveillance
Financing and Investment
Corporate Governance
Pricing Models and Taxation
Enterprise Resource Planning (ERP) Systems
FDA Inspections, Compliance, Enforcement, and Criminal Investigations 
Audits
Conflict of Interest and Financial Disclosures
Publications and Journal Impact Factor
Changing Clinical Practice Guidelines
Product Management
Product Marketing
Sales
Reimbursement
Intellectual Property
Strategic Alliances and Acquisition
Sunshine Law
International Business Code of Ethics with Healthcare Professionals
Fair Market Value Budgets in Research and Consulting Fees for Healthcare Professionals
UK Trade and Investment

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