DOCUMENTS

  • common technical document modules (nonclinical and clinical)
  • investigational medicinal product dossiers
  • clinical evaluation reports
  • development safety update reports
  • investigator’s brochures
  • orphan designation applications
  • protocols
  • clinical study reports
  • safety narratives
  • subject information sheets
  • informed consent forms
  • risk management plans
  • manuscripts
  • conference reports
  • standard operating procedures
  • training and evaluation materials

EXPERIENCE

MEDICAL PRODUCTS

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

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

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