Services

The following services are provided by The Clinical Specialist:

• Design of Clinical Development Plans
• Design clinical studies (Phase I, II and III)
• Writing/contributing to clinical study protocols, clinical study reports, IBs, IMPDs, DSURs and RMP
• Preparation of briefing packages to support scientific advice meetings
• Participation in scientific advice meetings as clinical representative
• Interactions with regulatory agencies (e.g. agency responses)
• Writing/contributing to clinical summaries of safety and efficacy and clinical overview
• Preparation of product information (e.g. SmPC, US PI)
• Clinical Evaluations (e.g. Due Diligences, phase transitions)
• Clinical Project Management
• Leading clinical development teams or clinical study teams