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medical writing

Clinical Protocols

ProtoMedical BioSciences, Inc. writes clinical protocols, including study design, investigational methodology, and statistical analysis planning. We provide complete regulatory documentation (phase 1 through 4), including INDs/NDAs, investigator brochures, and clinical study reports.

ProtoMed has extensive experience preparing clinical trial protocols and study reports according to FDA, ICH (International Conference on Harmonization), and GCP standards and guidelines.

ProtoMed has expertise preparing common technical documents (CTD) safety and efficacy sections according to ICH standards, for new market authorizations, prescription to OTC-switches, line extensions, orphan indications and applications for drugs with well-established use.

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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).

ProtoMed produces regulatory 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. See CIOMS for details.

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