Most statistical consultants and statistical experts in contract research organizations can plan and perform statistical analyses, but few are experienced in the strategic and regulatory considerations that are integral components of the full development process. It is this strategic perspective in which Strategic Statistical Consulting, LLC can add significant value to your clinical research program.
SSC provides their clients with more than 35 years of global experience in the statistical aspects of clinical development and regulatory submissions. We work with you to design clinical development plans, clinical protocols, and regulatory strategies. From an operational perspective, we can design statistical analysis plans, review clinical study reports and regulatory summaries, and provide guidance in the statistical aspects of regulatory submissions. We can also act as your statistical representative with regulatory agencies and CROs, if that expertise does not exist internally.
Our experience base includes directing the statistical aspects of global submission for more than 30 new molecular entities in 11 therapeutic areas and numerous submissions for expanded claims and combination products. We have presented at FDA advisory committee meetings, participated in more than 150 meetings with FDA personnel, and made personal presentations to the regulatory agencies of 10 countries. We also have experience in medical development strategy, medical writing, outsourcing, and clinical operations. We can bring this breadth of experience to your project and provide a complete and integrated statistical perspective that will add significant value to your projects.
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