As part of our mission to ensure sound scientific evidence in support of safe and effective products, our team emphasizes safety. We offer our clients a flexible suite of pharmacovigilance services during product development.
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. These services are available with data management as a flexible offering, or as part of full-service clinical trials.
Our clients benefit from single-vendor data management, ensuring adverse events are consistently coded across their platform of product lines. Pooling your data allows you to gain more insight and offers opportunities for publication and potential product development.
With government agencies mandated to evaluate the risk to benefit ratio, safety profiles of health products must remain a priority during the entire product life cycle. Reporting requirements vary by jurisdiction. Our clinical regulatory affairs team navigates regulatory complexities, streamlining the process so that our clients comply 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 assist our clients with medical data review and analysis, inclusion/exclusion criteria and clinical trial design, clinical study reports, and regulatory submissions.
The medical safety team is 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 safeguard patient safety and study integrity.
Learn how we can help you meet your clinical research objectives through our pharmacovigilance services.