DOCUMENTS

  • Common technical document modules (nonclinical and clinical)
  • Investigational medicinal product dossiers
  • Briefing packages
  • Clinical evaluation reports
  • Development safety update reports
  • Investigator’s brochures
  • Orphan designation applications
  • Protocols
  • Clinical study reports
  • Safety narratives
  • Lay summaries
  • Results postings
  • Informed consent forms
  • Risk management plans
  • Manuscripts
  • Conference reports
  • Standard operating procedures
  • Training and evaluation materials

EXPERIENCE

THERAPEUTIC AREAS

Cardiology, dermatology, endocrinology, genitourinary medicine, haematology, HIV/AIDS, immunology, infectious disease, metabolic disease, musculoskeletal, neonatology, neurology, nutrition, obstetrics/gynaecology, oncology (haematological and solid tumours), ophthalmology, orphan diseases, paediatrics, pain management, psychiatry, pulmonology/respiratory medicine, radiology, urology, virology

TYPES OF RESEARCH

Clinical trials (Phases 1 to 4), observational research, systematic review and meta-analysis, clinical guidelines, surveillance, literature review

MEDICAL PRODUCTS

Biologicals, diagnostics, gene therapy, medical devices, orphan drugs, pharmaceuticals, photodynamic therapy, stem-cell transplant, vaccines

CLINICAL RESEARCH ROLES

Writing, training, clinical science, clinical trial operations, compliance

EXPERTISE

  • Harmonization of your clinical trial design, operations, documentation, submission, and publications to achieve your goals
  • A structured plan for your project to ensure quality and timeliness of delivery
  • Smooth integration and cooperation with your team—wherever they’re located
  • Understanding of your objectives and your data from the start
  • Documents produced to the highest standard of clarity, accuracy, scientific rigor, and compliance
  • A problem-solving approach gained from extensive and diverse experience
  • Work conducted in accordance with your SOPs or with my established comprehensive set of SOPs, as you choose
  • Expert and up-to-date knowledge of clinical research guidelines, applicable regulation and guidances, and publication ethics
  • Reliable achievement of timelines
  • Cost-efficiency