Services
Tulip Medical Consulting, LLC. can provide you with the following services specifically tailored to meet your company's needs:
- Clinical expertise in Pediatrics, Vaccinology, Immunology, Infectious Disease and Nephrology
- Scientific advice on identification of appropriate clinical endpoints, surrogate markers and patient population for your product
- Preparation and Review of IND and CTA submissions (non-clinical and clinical sections)
- Strategic input in Clinical Development decision-making
- Design of and advice on Clinical Development Plans
- Writing and review of clinical protocols, Investigator Brochures, Clinical Study Reports and other study-related documents
- Participation in and preparation of ad-hoc and scheduled meetings with FDA and other global regulatory authorities
- Selection, management and oversight of investigational clinical sites, Contract Research Organizations and other vendors
- Leadership of clinical trials including Medical Monitoring and line-management oversight
- Organization and participation in Data Monitoring Committee (DMC) and SEAC (Safety Evaulation and Adjudication) activities
- Interpretation & analysis of clinical trial results
- Preparation and review of BLA sumbissions
- Development and successful maintenance of critical relationships with key opinion leaders, advocacy groups and scientific organizations
- Competitive analysis
- Commercial support throughout the product life cycle
-
© Copyright 2010-2017 Tulip Medical Consulting, LLC.