Melanie McBride's Contact Details

Melanie McBride's Company Details

We are a development team comprised of subject matter experts with substantial hands on experience in translational oncology medicine including pre-IND through Phase III/NDA/BLA international oncology development programs. Core Services/Expertise:Structuring of strategic transactions and for due diligence for investmentHow to structure productive university/industry collaborations and partnershipsGAP analyses and strategy for your drug development program from bench to bedside with the aim to cost-effectively achieve the maximum commercial potential for your therapeutic programPreparation for pre-IND meetingsDesign, contracting, and oversight of GLP pharmacology and toxicology studiesDomestic and international Phase I to Phase III trial design, protocol development, feasibility, site selection, and trial management and executionVendor evaluation, selection, negotiation, oversight and management to assure quality, performance and budget compliance - we will save you moneyStrategic planning for commercial development to maximize your investmentEfficient logistics for trial design, implementation, execution, analysis and reportingDrug safety oversight, medical monitoring/assessment, and reporting in compliance with FDA and ICH regulations and guidancesMedical writing for all phases of development, NDA/BLA submissionsInternational regulatory expert services including strategy, communications, meetings, and discussionsStandard operating procedures, policies, and process implementation to enable your company to build an efficient, and compliant operational infrastructure for clinical developmentWe have an extensive international network of key opinion leaders in various disease areas of oncology that we can provide for any development programWe can provide interim management oversight for medical, clinical operations and project management - and help you build your own internal clinical development team