Healthcare and Pharmaceuticals
- Clinical Research Project Management
Methodologies: Application of project management methodologies specific to clinical trials, including phase planning, risk management, and regulatory compliance.
Tools: Use of clinical trial management software such as Oracle Clinical and Medidata to track patient data, manage protocols, and analyze results.
Case Study: Management of a clinical research project for the development of a new drug, reducing time to market through effective process management.
- Regulatory Compliance
Standards and Guidelines: Expertise in compliance with GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), and FDA regulations.
Audits: Conducting internal audits to identify gaps, ensure continuous compliance, and prepare for regulatory inspections.
Practical Case: Assisting a pharmaceutical company in complying with GMP standards, reducing the risks of non-compliance and production interruptions.
