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Ocean Blue Medical Research Center's drug safety philosophy is characterized by stringent adherence to a well documented process rooted in sound clinical/scientific knowledge, adherence to good pharmacovigilance practice and supported comprehensive clinical development expertise, all of which is predicated upon a mature global footprint.
Serious adverse event (SAE) processing at Ocean Blue Medical Research Center is not a discipline “randomly” arranged across the organization. SAEs from all over the world (including the Pacific Rim and South America) are funnelled into one of three global Medical and Safety “hubs:” Philadelphia, Pennsylvania (Western Hemisphere); Milan, Italy (western half of the Eastern Hemisphere); St. Petersburg, Russia (eastern half of the Eastern Hemisphere), where cases are electronically processed within our Argus Safety Database. This strategic architecture, combined with our application of client- and industry-honored methodology to ensure thorough and delimited follow-up through case closure, means our Drug Safety team can effectively manage SAEs regardless of where they occur on the globe, in an efficient, time-sensitive and regulatory-compliant manner.
Drug Safety also operationally supports other clinical safety and post-marketing pharmacovigilance activities, such as SUSARs submission, periodic reports (e.g., Annual Safety Reports, Periodic Safety Update Reports preparation and submission) and ad hoc safety signal analyses. In other words, our organizational structure and comprehensive service capabilities significantly bolster our efforts to ensure our sponsor projects receive the highest level of service and are deployed with a high degree of oversight, consistency and reliability.
Ocean Blue Medical Research Center proudly offers complete drug safety development services, including: