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