Selected Projects

Selected Consultancy Projects:

  • Collaborate with a US regulatory consultant for developing biotech companies strategic clinical development plans
  • Collaborate with a European regulatory consultant for developing pharmaceutical company strategic clinical development plan for a respiratory product
  • Assist in developing study specific procedures and forms as well as CRF design for a medical device company

Selected Medical Writing projects:

  • Clinical Study Protocols for phases I-IV for IMPs (investigational medicinal products), marketed products, medical devices, diagnostics and comibination products in different therapeutic indications (dermatology, comsmetic application, endocrinology, oncology, metabolic disorders, respiratory diseases, GI, central nervous system and infectious diseases) for different clients (including large pharmaceutical, medical device, diagnostic and biotech companies)
  • Clinical Study Reports for phase II-III studies for different products/therappeutic indications (cosmetic application, metabolic disorder, endocrinology, diabetes, anti-infective, vaccines) for different clients
  • Investigator brochures for biologics, gene therapy, medical device, diagnostics and combination products (therapeutic indications: osteoporosis, endocrinology, obesity, graft vs. host disease, anemia, connective tissue disorders, anti-infective, imaging, GI) for different clients
  • Annual Safety Reports for phases I-II studies in oncology for a mid-size pharmaceutical company
  • Risk/Benefit assessment as part of Clinical Trial Application for a combination product (therapeutic field: endocrinology) for a large pharmaceutical company
  • Risk Management Plans (RMP) for EU submission for biotech companies
  • Literature review for metabolic disorders
  • Preclinical study protocol for a cardiovascular indication
  • Preclinical study report for an imaging technique /li>
  • Integrated Summary of Safety for a multinational pharmaceutical client (indication: Alzheimer's disease).
  • Annotated report outlines for 11 final study reports for a global pharmaceutical company (indications: dysthymia, chronic depression, major depression).
  • End of Study report for a Phase I study for a mid-size pharma company (indication: Alzheimer's disease).
  • Safety narratives for US and European studies for a global pharmaceutical company (indication: Alzheimer's disease).
  • Academic manuscripts and abstracts on learning and memory topics.
  • Study specific SOPs and protocol review for a French pharmaceutical company (indication: acute otitis media)