Areas of Expertise

 

Medical Affairs

  • Publications planning

  • Primary research manuscripts

  • Review articles

  • Abstracts, posters, presentations

  • Systematic literature search and evaluation

Clinical Affairs

  • Evidence portfolio management

  • Clinical study design and protocol development

  • Clinical study reports (CSR)

  • Post-market clinical follow-up planning (PMCF)

  • Structured literature reviews

Regulatory Affairs

  • Regulatory filings, including for FDA and EU MDR

  • Clinical evaluation reports (CERs)

  • Health hazard evaluation (HHE) reviews

  • Medical monitoring of adverse events (AEs)

  • MDR summaries, reviews of predicate technology

 

Quality Affairs and R&D

  • Preclinical and basic research manuscripts

  • Internal QMS documents

  • Complaint review medical support

  • Complaint evaluation and trend analyses

  • Competitive product outcomes landscaping

  • Systematic literature search and evaluation

Marketing Communications

  • White papers & case studies

  • Sales training

  • Placed/bylined articles and opinions (trade, business and consumer)

  • Press releases, web, blog, and social media content

  • Video scriptwriting and voice over, speeches

  • Sales collateral

Ancillary Services

  • Biostatistics, including statistical analysis plans (SAP)

  • Health Economics Outcomes Research (HEOR) planning, execution, and reporting

  • Graphic design

  • Medical illustration