ProtoMed BioSciences, Inc. provides comprehensive medical writing and clinical trial support for the biomedical and healthcare industries.
ProtoMed produces regulatory documentation (phase 1 through 4), including medical writing of INDs/NDAs, investigator brochures, clinical protocols, clinical study reports, as well as electronic common technical documents (eCTD).
ProtoMed's team of physicians, scientists, and medical writers combine critical-thinking and project-management skills with the ability to clearly communicate complex medical and scientific topics. With a passion for excellence, our medical writers consistently produce the finest medical writing available.
ProtoMed has extensive experience with medical writing of clinical trial protocols and study reports 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 has extensive experience preparing thorough QT/QTc studies (TQT studies), submissions compliant with CIOMS I-VII, including periodic safety update reports (PSURs), integrated summaries of safety and efficacy (ISS/ISE), case report summaries, periodic adverse drug experience reports (PADERs), adverse event (AE), and serious adverse event (SAE) narratives. See CIOMS for details.
ProtoMed prepares primary manuscripts and review articles for journal publication. All medical writing of manuscripts for journal submission is in accordance with ICMJE (International Committee of Medical Journal Editors), and adheres to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement for medical writing of observational studies.