Alpha Omega Oncology Development Services Information

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 investment How to structure productive university/industry collaborations and partnerships GAP 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 program Preparation for pre-IND meetings Design, contracting, and oversight of GLP pharmacology and toxicology studies Domestic and international Phase I to Phase III trial design, protocol development, feasibility, site selection, and trial management and execution Vendor evaluation, selection, negotiation, oversight and management to assure quality, performance and budget compliance - we will save you money Strategic planning for commercial development to maximize your investment Efficient logistics for trial design, implementation, execution, analysis and reporting Drug safety oversight, medical monitoring/assessment, and reporting in compliance with FDA and ICH regulations and guidances Medical writing for all phases of development, NDA/BLA submissions International regulatory expert services including strategy, communications, meetings, and discussions Standard operating procedures, policies, and process implementation to enable your company to build an efficient, and compliant operational infrastructure for clinical development We have an extensive international network of key opinion leaders in various disease areas of oncology that we can provide for any development program We can provide interim management oversight for medical, clinical operations and project management - and help you build your own internal clinical development team