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Clinical Study Reports
ProtoMedical BioSciences, Inc. produces clinical study reports, including pharmacokinetic, bioavailability, bioequivalence, and later phase trials. We provide complete regulatory documentation (phase 1 through 4), including INDs/NDAs, investigator brochures, and clinical study reports.
ProtoMed has expertise 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.
ProtoMed has medical writing expertise producing and clinical study reports (CSRs) and clinical protocols, according to FDA,ICH,
and GCP regulations and standards. All medical writing of clinical study reports is in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines.
ProtoMed can write whole 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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