After 5.5 years as a US FDA Investigator in the bioresearch monitoring (BIMO) and biologics area for domestic and international inspections, I decided to alter my direction to assist industry in assuring they were inspection ready. With 16 years of clinical research experience, I am committed to efficiently meeting clients' needs, with patient safety and data integrity at the utmost importance. Talk to us today about how we can support your program.
Our service includes a comprehensive consult to help identify compliance gaps and opportunities for improvement, a comprehensive report that includes a project plan with realistic objectives, timelines, milestones, and a schedule.
Adequate training is essential to the performance of personnel. CRSC can tailor a training program appropriate for your personnel, based upon their level of education, experience, and assigned duties. That’s how we ensure your success.
Experienced quality assurance professionals are key—Clinical trials are an important step to prove the safety and efficacy of new drugs and devices in order to obtain regulatory authority approval for marketing. At CRSC, we take pride in delivering exceptional auditing, monitoring, and training consultant services for Phase I, II, III, and IV clinical trials, globally.
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