Pharmacovigilance and Medical Information Overview

Our Pharmacovigilance and Medical Information staff has provided our clients with pre- and post-marketing drug safety services for nearly a decade. Our services include:

• Pre-Marketing Pharmacovigilance
• Post-Marketing Pharmacovigilance
• Medical Information

Our personnel are experienced in a variety of therapeutic areas, including: oncology, immunology, rare diseases (such as lysosomal storage diseases), allergy, asthma, endocrinology, device, ophthalmology, orthopedics, hematology/thrombosis, CNS disease, dermatology, oral contraceptives, cardiac disease, infectious disease, and bone marrow transplant. Our team of well-trained professionals includes diverse and complementary technical backgrounds in medicine, nursing, and public health.

We are committed to ensuring drug safety and dedicated to continual education of the individuals involved in collecting, processing and analyzing this data. To that end, we have developed an extensive training program for our in-house and client-embedded Pharmacovigilance personnel.

Our client profiles range from start-up to large pharmaceutical companies with multiple development programs and marketed products. Our team has worked in a variety of capacities on behalf of client organizations to:

• Integrate trained personnel into client PV teams to provide additional resources, training, support and expertise for the management and processing of AEs and SAEs. Our personnel have experience in the areas of drugs, biologics and medical devices for both clinical trials and post-marketing projects. We are capable of supporting long-term contracts for which our personnel have dedicated space at the client organization and work on client systems, programs and databases.
• Provide PV and MI hosting services for clients with their own database system but who require additional personnel for case entry and processing. We can provide a dedicated, secure space for case entry and processing to occur via dedicated T1 line and can set up levels of security per client specification.
• Provide pharmacovigilance services to clients in a stand-alone capacity or as part of a total clinical trial management package.
• Provide Chief Medical Officer (CMO) services for clients without medical personnel, including representation services to scientific advisory boards and for investment presentations.