Consultant
Current• Program/Project Management services include budget design and negotiations, CMC oversight, clinical protocol development, CRF design, CRA and vendor management, site selection, recruitment/enrollment support, conducting team meetings, training, acting as liaison between site, CRAs, and sponsor, troubleshooting and resolution of site/sponsor issues, and proactive monitoring of study progress to ensure both regulatory and sponsor expectations are met. • In-House CRA services include printing and distribution of CRFs and associated study materials to sites, inventory shipping, management, and tracking, and maintaining custom on-line study management portal, collection, review, tracking, and storage of Site Master File and Trial Master File documents (ICH and DIA models), with secure hardcopy and electronic storage • Auditing services include vendor and clinical site qualification and GMP/GLP/GCP audits• Medical Writing services include IND/IMPD amendments, annual reports, Investigator’s Brochures, protocols, study-related materials, and final reports.• Regulatory services include creation, editing, updating, and filing support for IND, IMPD, and Orphan Drug programs with US and foreign regulatory agencies.• Data Management services include design and programming of VB/VBA-based software systems for data consolidation/transformation and generating reports.