ICON offers global, robust clinical development consulting to virtual companies, start-ups, biotechs, pharmaceutical, and medical device sponsors
Why work with us
We understand your strategic vision, working as an extension of your internal team, serving as your trusted partner. We address cross functional questions and understand the impact of gaps.
Working with us will give you a deeper understanding of development options, with respect to scientific and regulatory risks, costs and timelines, to meet overall business objectives. It also means you gain access to in-depth scientific expertise across disciplines for ad hoc support.
We offer you full lifecycle support, helping clients to develop target product profiles, synopses, protocols, clinical development plans and regulatory advice documents. Our innovative solutions, such as the use of adaptive design and operational adaptations in enrolment, data quality and enrichment designs, can optimize development efficiency. The strategies we use to maximize critical path development and minimize time-to-market include:
- Recruitment strategies
- Feasibility assessments
- Use of imaging, biomarkers
Other services include:
- Preparation of product development plans
- Protocol development assistance: consultation on study designs, endpoints, objectives, measurements and statistical analyses
- Scientific and medical oversight of on-going trials
- Patient recruitment and retention strategies
- Liaison with KOLs and collaborative groups
- Investigator/sponsor relationships
- Development of academic advisory boards
- Due diligence for individual disciplines and/or across disciplines for asset assessment to support acquisitions, etc.
- Ad-hoc consulting
- Short to mid-term dedicated client support
- Provision of an integrated package of clinical expertise
- Therapeutic area and protocol training
- Project strategy oversight
- Assistance with scientific publishing
Out team can help you to plan and prepare development teams for interaction and negotiation with regulatory agencies. This encompasses regulatory, CMC, clinical and toxicology matters, and development of pre-meeting packages.