Clinical Trial Applications

Ergomed’s clinical trial application services encompass many support activities to streamline the regulatory process. Our services include:

• Pharmaceutical Regulatory Affairs Consulting
• Pre-IND/CTA Meetings and Development of Briefing Packages
• Input to Protocol Development, Feasibility, and Country Selection
• Definition of Regulatory Submission Strategy and Risk Mitigation Plans
• Authoring and Review of Technical and Scientific Submission Documents
• Facilitating Approvals with National Regulatory Agencies
• Proactive Risk Mitigation

Our team offers expertise in strategic and local pharmaceutical regulatory affairs, facilitating approvals from national regulatory agencies and ethics committees (IRB/IEC) for phase I-IV trials, noninterventional/observational studies, and device investigations. Combining global insights with local knowledge ensures that your submissions comply with all relevant regulations and standards.

Our proprietary regulatory intelligence database and performance metrics are a game-changer in developing effective regulatory submission strategies. This powerful tool empowers us to gather and analyze critical regulatory information, enabling us to create optimal execution plans and achieve rapid study start-up. By harnessing this data-driven approach, your regulatory submissions are both timely and efficient, giving you a competitive edge.

At Ergomed, we provide expert guidance and support to ensure predictable clinical trial application timelines. Our comprehensive range of services, strategic and local regulatory affairs expertise, and proprietary regulatory intelligence database equip us to navigate the complex regulatory landscape effectively.

By partnering with Ergomed, you benefit from our extensive experience and commitment to excellence, as well as our smooth and efficient handling of your clinical trial applications.