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Pharmacovigilance and Drug Safety
ProtoMed offers proactive drug safety surveillance programs that include comprehensive risk management plans and signal detection/analysis throughout a product's lifecycle.
Pharmacovigilance, the continuous safety monitoring of marketed medicines, is essential to the long-term success of every drug. As healthcare providers and regulators demand a demonstrated commitment to safety that goes beyond mere compliance, pharmacovigilance pushes new boundaries and it is no longer sufficient to simply report adverse events.
ProtoMed offers post-marketing pharmacovigilance assessments, data audits, safety system implementation, hosting and maintenance utilizing ARISg, ARGUS and Oracle AERS. We have extensive experience preparing submissions compliant with CIOMS I-VII, including periodic safety update reports (PSURs), integrated summaries of safety (ISS) case report summaries, periodic adverse drug experience reports (PADERs), adverse event (AE), and serious adverse event (SAE) narratives. All documentation is in accordance with FDA, CIOMS, ICH (International Conference on Harmonization), and GCP standards and guidelines.
ProtoMed can write whole sections or parts of sections, and depending on our clients’ needs, add to existing files, edit, update, and prepare dossiers in paper form or as fully hyperlinked
electronic common technical documents (eCTD).
We also deliver investigator brochures, clinical trial protocols, and clinical study reports, NDAs, and eCTDs in accordance with ICH guidelines.
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