Robust advisory services to virtual companies, start-ups, biotech, pharma and medical device developers.
With over 30 years of experience and expertise, we are able to quickly understand your strategic vision and work as an extension of your internal team. We efficiently address cross-functional questions and identify and understand any gaps.
Our experts deliver a deeper understanding of development options, addressing scientific and regulatory risks with respect to cost and timelines, to meet your overall business objectives. With ICON as your trusted partner, you have access to in-depth therapeutic expertise across disciplines, for comprehensive ad hoc support.
Comprehensive services and advice
We offer support and services to prepare an integrated development plan that will address clinical development, regulatory affairs, CMC strategy and implementation. We help clients to maximise their critical path development and minimise time to market, through a comprehensive range of consulting services, including:
- Portfolio management and prioritisation
- Asset evaluation / asset due diligence for acquisition and investment decisions
- Integrated drug development planning and consultation
- Indication evaluation, selection and prioritisation
- Chemistry, manufacturing, controls (CMC)
- Preclinical development
- Clinical trial design / clinical development consulting
Asset development insights
The importance of formulation studies in drug development
Formulation studies require time, money and expertise, and the race to clinic and beyond may tempt drug companies, especially smaller ones, to take shortcuts that end up costing more later.
Regulatory agencies encourage use of adaptive designs
FDA and EMA thinking on adaptive designs has progressed significantly, and support for the approach has strengthened.
Clinical development of cell and gene therapies
ICON experts discuss the intricacies of CGT development, the solutions that will enable CGT development on a global basis, and the future of CGT clinical trials.