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Clinical Trials
ProtoMed BioSciences, Inc. provides full-service and comprehensive services for
conducting phase 1-4 clinical research studies, including study design, patient recruitment, accelerated enrollment, and study continuity. ProtoMed provides complete project management from first in human, regulatory phase I, and exploratory early phase trials, to phase II-IV trial implementation and medical monitoring.
ProtoMed produces regulatory documentation (phase 1 through 4), including INDs/NDAs, clinical protocols, investigator brochures, and clinical study reports.
ProtoMed develops protocols and clinical study reports according to
FDA, ICH (International Conference on Harmonization), and GCP standards and guidelines.
ProtoMed
prepares 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 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.
ProtoMed provides medical writing of clinical study reports and clinical trial protocols (CSRs), 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.
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