Pharmaceuticals

Clinical Research

• Clinical Trial Management: Overseeing clinical trials from start to finish, ensuring compliance with protocols and regulatory requirements.
• Protocol Development: Creating and refining clinical trial protocols to meet scientific and regulatory standards.
• Investigator Site Management: Managing relationships with clinical trial sites and ensuring adherence to trial protocols.
• Clinical Data Management: Ensuring the accurate and secure handling of clinical trial data.
• Biostatistics and Data Analysis: Applying statistical methods to analyze clinical trial data and ensure its integrity.

Regulatory Affairs

• Regulatory Strategy Development: Formulating strategies to navigate regulatory pathways for clinical trials.
• Regulatory Submissions and Approvals: Preparing and submitting regulatory documents for clinical trial approvals.
• Regulatory Compliance Audits: Conducting audits to ensure compliance with regulatory requirements.
• Regulatory Liaison Services: Acting as a liaison between companies and regulatory bodies.

Pharmacovigilance

• Adverse Event Reporting: Monitoring and reporting adverse events during clinical trials.
• Risk Management Plans: Developing and implementing plans to manage risks associated with clinical trials.
• Signal Detection and Management: Identifying and managing safety signals during clinical development.
• Safety Data Analysis: Analyzing safety data to ensure the well-being of trial participants.