Medical Affairs and Pharmacovigilance
As part of our mission of ensuring sound scientific evidence in support of safe and effective products, our team places emphasis on product safety. We offer our clients a flexible suite of pharmacovigilance services during product development.
As part of data management as a flexible service offering, or as part of full-service clinical trials, Nutrasource provides MedDRA coding for all adverse events, individual case safety report (ICSR) processing for serious adverse events prepared by MDs, safety update reports, and regulatory compliance and consulting. Our clients can benefit from single-vendor data management, ensuring that adverse events are consistently coded across their platform of product lines. Pooling your data allows you to gain more insight to your products and offers opportunities for publication and potential product development.
With regulatory agencies mandated to evaluate the risk-to-benefit ratio, safety profiles of health products must remain a priority during the entire product lifecycle. Regulatory reporting requirements vary by jurisdiction. Our team navigates regulatory complexities, streamlining the process to ensure our clients are compliant with local and global regulations.
Our medical staff promote patient safety to internal and external project teams, providing site education and training for study teams on medical/disease states, laboratory procedures, protocol compliance and potential study issues. We also assist our clients with medical data review and analysis, clinical study inclusion/exclusion criteria and design, clinical study reports and regulatory submissions.
The medical safety team are pivotal to monitoring protocol deviations and violations. Granting protocol waivers is extremely rare, but where appropriate are secured through written approval of the Sponsor after review by our medical team to ensure patient safety and study integrity.
Looking for more information on medical affairs or pharmacovigilance? Contact a member of our team today or email us directly at email@example.com. You may also request a customized quote and we will contact you with details within two business days.