of Clinical Development
The team at Mitchell Clinical Consulting is highly skilled and experienced, having worked in clinical development within both large pharma and small biotech for periods ranging from 14-19+ years.
We bring a unique approach to our services as we have:
- a thorough knowledge and understanding of the drug development process, from pre-clinical development to product registration
- an in-depth understanding of the practical and regulatory framework for clinical development
- a demonstrated track record in the design and implementation of clinical trials (Phases I to IV)
- an appreciation of the need to incorporate regulatory and commercial imperatives when designing trials and planning development programmes.
- a first-hand understanding of the unique challenges that face emerging biotech companies
Mitchell Clinical Consulting is lead by Dr Sue Mitchell who has experience across the pharmaceutical, biotechnology and academic sectors, and has held senior management positions with AMRAD Corporation (Director of Clinical Development) and CSL Ltd (Head of Clinical Operations). In these roles she was responsible for the global strategic vision, planning and execution of more than 25 clinical development programmes of biological and new chemical entities, spanning Phases I (first in man) to IV, as well as bioequivalence/bioavailability studies. These development programmes represent a broad range of therapeutic indications. She was also responsible for the establishment/re-engineering of the clinical research departments, including the introduction of quality systems and procedures to ensure compliance of all clinical development activities with the highest international regulatory standards and industry best practice.