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Council for International Organizations of Medical Sciences (CIOMS)
CIOMS is an organization set up under the auspices of the World Health Organization and UNESCO. It has produced a series of guidelines including the international reporting form (CIOMS I); periodic safety update reports (CIOMS II); core data sheets (CIOMS III); benefit-risk assessments (CIOMS IV); practical issues in pharmacovigilance (CIOMS V); clinical trial safety data (CIOMS VI); and development safety update reports (CIOMS VII). The CIOMS Guidelines are formally known as the International Ethical Guidelines for Biomedical Research Involving Human Subjects. These were developed and are updated by a committee of volunteers from industry, governmental and regulatory authorities, the WHO and others.
ProtoMed has 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).
Our medical writers deliver investigator brochures, clinical trial protocols, clinical study reports, NDAs, and eCTDs in accordance with ICH guidelines.
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