Scientific Document Guidance

RxMD enhances scientific documents as true "physican editors". Our firm has demonstrated a breadth of expertise for several critical clinical documents.

 

Value Added Study Reports

Quality conscious Indian CRO (responsible for clinical operations, data management and statistics) partners with RxMD to write study report for a European sponsor. RxMD identifies an inadequate SAP and statistical outputs. RxMD redefines safety and efficacy analysis populations, violations and deviations and oversees the generation of new safety and efficacy outputs for appropriate populations, and delivers final study report.

 

Study Reports for Filing

RxMD requested to author study report for phase III trial in children. RxMD report forms mainstay of supplemental NDA which meets FDA approval.

 

Integrated Summaries

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

 

Marketing 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.

 

Establishing Manufacturing Standards

Sponsor's multi-million dollar drug inventory unreleased due to microbiologic contamination. RxMD authors a medical assessment evaluating the contaminant, degree of contamination, and sets manufacturing standards by developing written protocol for the evaluation of suspected microbial contamination.

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