We offer a wide range of statistical, management, and due diligence services to the biopharmaceutical and biotechnology industries.

Statistical Services

• Development and implementation of statistical design, analysis, and presentation strategies and methodologies for global clinical programs and studies.
• Integration of scientific evidence for efficacy and safety summaries.
• Review and evaluation of clinical dossiers, CMC section, pre-clinical safety sections, integrated summaries, reports, protocols, and methodologies.
• Presentation and defense of statistical methodologies and conclusions before regulatory agencies, advisory, and scientific boards.
• Assist existing project team in preparation and practice for upcoming presentations to regulatory advisory committees.
• Establish and manage a Statistics Department. When fully operational and efficient, transfer management to the team that has been put in place as part of the department's creation.

Management and Organizational Services for Drug Development Process

• Design and set up efficient, global drug development support structures.
• Design improved workflow and procedures for clinical product development.
• Develop product knowledge bases to leverage accumulated company knowledge to accelerate transitioning new product from Development Team to Marketing Team.

Project and Resource Management Services for Staging of Complex Projects

• Advise and assist project directors in planning, selecting and managing internal and external resources such as Clinical Research Organizations (CROs), Contract Research Laboratories (CRLs), Contract Manufacturing Organizations (CMOs) data management, document management, and statistical services vendors. Troubleshoot to keep project on schedule.
• Serve as project director. Provide project plan and identify, evaluate, and procure resources needed for multinational development project. Manage the project to a stage where management and control can be transferred to a team that has been put in place as project progressed.

Due Diligence Services for Licensing and Investment Decisions

• Evaluate and confirm preclinical and clinical study results and methodologies reported in prospectus portfolios.
• Assess the quality of the work submitted in the portfolio and its acceptability by regulatory agencies to establish safety and efficacy of the product.

Educational Services

• Provide customized courses and workshops in statistics, in design and analysis of clinical trials, and non-clinical experiments.
• Prepare scientific or promotional documents from approved New Drug Applications (NDAs) and clinical trial results.