A Strategic Approach To Clinical Trials.
We can assist you with any size study including large-scale trials involving sophisticated designs and long-term follow-up across clinical settings and geographies. Lincé Consulting takes a strategic approach to clinical planning and integrates regulatory, quality, and marketing concerns into the clinical plan up front. Lincé Consulting offers comprehensive clinical trial design and management services including protocol development, monitoring, data management and reporting.
Lincé Consulting will work with you to ensure that the clinical trial design will help you achieve your business objectives - whether those are short- or long-term in nature. We can manage your entire clinical program or any part of it. You decide what best fits your product, team, and company.
Global Clinical Services:
- Study initiation and development in accordance with strategic objectives.
- US and international trials including developing protocols, obtaining FDA/Health Ministry and IRB/Ethical Committee approvals, physician selection, monitoring sites, data management and reporting.
- Clinical investigation and market approvals, including IDE/IND, IRB/EC and international applications and participation in PMA/NDA and Panel Meeting process.
- Government audit support.
- Development of protocols, CRF's, Investigator Brochure and other required study documentation.
- Monitoring of results to ensure compliance with IDE/IND, GCP, ICH, ISO and other international regulations.
- Data Acquisition/Analysis and presentation for submissions and publications for FDA and international regulatory agencies.