Extensive experience in successfully managing early clinical stage products in multiple therapeutic areas ensures a thorough understanding of the overall process. The key to success is through design and implementation of the most efficient, integrated plan to achieve the strategic goal, clinical timelines and corporate objective. A coordinated, multidisciplinary approach, contingency planning and effective problem solving, combined with careful, informed selection and management of vendors is one of the signature services provided by WinPharm. Clinical trial management and monitoring Clinical project management Investigator identification, qualification and registration Clinical site training and management Site monitoring Adverse Event review and documentation Study procedure manuals Enhanced vendor selection and management in the following areas Data management Biostatistics Contract clinical research organization selection and oversight Chemistry and formulation development Analytical development Clinical trial drug manufacturing, packaging and distribution Central laboratory Contract and budget negotiation and administration Data management planning and tracking CRF development and completion instructions Oversight of database design, validation, quality control, clean-up and lock Data Management Guidelines and edit specifications Randomization planning and implementation Study Master File and SOP creation and maintenance Investigator meetings

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