Scientific Medical Writing

Scientific Medical Writing Services comprise authoring of simple documents for complex topics such as clinical sections of a US filing, clinical expert report for EU, summarizing safety data for class action lawsuits, RMP based on diagnostic (biomarker) rescue for a therapeutic agent, and sensitive scientific manuscripts for publication.

RxMD enhances scientific documents as true "physician-scientist editors". RxMD adds value by determining what outputs need to be generated, interpreting them and telling a cogent, compelling, defensible, yet medically simple and lucid story.

Integrated Summaries

RxMD contracted to write Integrated Summary of Safety. RxMD detects high incidence of accidental injuries and requests Sponsor to gather additional information to categorize accidents for analysis. RxMD concludes accidents are unrelated to drug, which subsequently meets FDA approval.

Class Action Lawsuit

Pending class action lawsuit for an adverse effect, and regulatory assessment report, Sponsor requests RxMD to extensively evaluate causality. RxMD defines a reproducible methodology for identification and systematic manual medical review of cases from Sponsor's drug safety database, develops strategy for review of claims databases, liaises with Sponsor's external subject-matter experts and finalizes report to be submitted to regulators and the defense team.

Dx Rescue for Rx

Sponsor's drug withdrawn from major markets because of unanticipated toxicity. Sponsor identifies pharmacogenomic marker for adverse event and submits RMP to EU authorities who request extensive revision of RMP. RxMD reviews several hundred listings, figures and tables from pharmacogenomic study, previous study reports and rewrites RMP to tell convincing story in a free standing, independent document well received by the Sponsor, who submits revised RMP and returns to RxMD for other projects.

Scientific Manuscripts

Sponsor uncertain about preferred medical writing company being able to interpret sensitive maternal exposure data for birth defects and author manuscript. RxMD creates mock tables for Sponsor's programmers to generate correct listings and outputs for analysis of pregnancy and fetal outcomes. RxMD then authors a report which forms the basis for manuscript to be written by medical writing company.