About our list of Services

Use the column to the left to read important details and topics regarding each service in particular

We ecourage you to contact Ocean Blue Medical Research Center for more questions and/or information about our services.

Product Safety and Pharmacovigilance

Ocean Blue Medical Research Center' pharmacovigilance philosophy is characterized by stringent adherence to a well documented process rooted in adherence to good pharmacovigilance practice and supported by expertise in marketed product management.

Innovative Operational Approach

Our pharmacovigilance department operationally supports our complete late-phase/peri-approval services by offering preparation of quarterly and periodic aggregate reports, Trending analysis and ad hoc safety signal analyses, in addition to the all-important review of solicited and spontaneously reported adverse drug reaction/experience case data. We offer expert consulting on the design and implementation of REMS and RMPs with a niche skill set in global execution of integrated solutions, given the distinct differences between the major regulators in this area.

We serve as the safety department for companies lacking their own in-house resources and confidently manage the transition of IND compounds to marketed products, added to which, we can interface seamlessly with your drug information services groups or provide you with an integrated solution of our own. These are just some of the services and means by which Ocean Blue Medical Research Center can serve your marketed product support needs, providing the highest level of service along with the highest degree of oversight, consistency and reliability.

Ocean Blue Medical Research Center' pharmacovigilance proudly offers complete marketed product support services, including:

  • Post-Marketing Surveillance
  • SADR, spontaneous ADR processing and reporting
  • Late Phase Support
  • Registries, Phase IV trials
  • SAE processing and reporting
  • Lab and diagnostic test review
  • PSUR, Annual and Quarterly Report Preparation
  • Signal Detection Services
  • Trending analyses for labeling changes
  • Argus Safety Database
  • REMS/RMP Design and Advisory Consultation
Last update: 07/7/2015 11:24
Content updated on Monday, 10-2-2017 04:35:40 am