When managing your drug’s risks, compliantly answering questions about your product, and reporting adverse events to the FDA, our trusted, well-trained team of pharmacovigilance, REMS support and medical information specialists can serve as your first line of contact with patients, caregivers and providers.
Pharmacovigilance services that drive compliant reporting
Pharma companies are required to report all adverse events they become aware of to the FDA. Because adverse events can be disclosed in any patient interaction, our patient-facing team is trained to understand how to compliantly record and report such disclosures in our validated safety database. We deliver pharmacovigilance data back to you, formatted according to your standard operating procedures, for FDA reporting purposes.
REMS program support
We can support your risk evaluation and mitigation strategy (REMS) programs, providing the services needed to collect and maintain all data elements for your mandated reporting to the FDA. We can help you meet requirements to educate and raise awareness of risks that may be associated with taking your drug by disseminating drug safety information to healthcare providers and patients. We can also implement medication guides
to inform patients of your drug’s specific risks.
Providing medical information to drive adherence
Our trained team can compliantly provide patients, caregivers and providers with current, accurate medical information to answer questions about your product – using FAQs and other data, tailored to your specific requirements.
If your biopharma company has REMS requirements to coordinate, we can help
Our team can help you meet REMS requirements to understand and improve drug safety. Contact us today.