Scientific Medical Consulting Services

RxMD's peer-to-peer Scientific Medical Consulting Services straddle drug development, drug safety, data interpretation, and writing of documents on complex topics.

Drug Development Services

Drug Development Services focus on simple, cost effective clinical development based on good science. RxMD's Due Diligence Services (for VC, PE, biopharma partnering clients) entail exhaustive review of relevant data to ensure that there is well established preclinical proof of efficacy/differentiation. RxMD's Clinical Development Consulting Services lay emphasis on risk benefit assessment to quickly establish need for further development. RxMD designs scientifically sound studies with careful selection of end points that are approvable and marketable.

Scientific Safety Research Services

Scientific Safety Research Services include comparison of blinded adverse event rates with background rates and close scrutiny of serious adverse events for causality during the clinical trial phase. Post-marketing Safety Research Services include analysis of aggregate unlabeled adverse events for a causal association, mitigation of labeled events by evaluating causal role of underlying disease, assessing impact of microbial contamination of non-sterile oral formulations and authoring of drug safety reports.

Scientific Medical Writing Services

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.


 

Evolution and
Key Milestones

Drug Development: 2000-
  NDAs HCV, HBV, flu
  Pediatric bridging NDA - HIV
  Safety signals antibiotic, RA
  IND Genomics, HCV, cachexia
  Now Rx preterm/term infants

Document Writing: 2002-
  Study reports, RMP, ISS, ISE
  Recent Manuscripts published

Safety Assessments: 2007-   Aggregate events
  Sub-groups - infants, pregnancy
  Situations - pandemic
  Drug-drug interactions
  Product contaminations
  Recent Dx rescue, lawsuit