- Common technical document modules (nonclinical and clinical)
- Investigational medicinal product dossiers
- Regulatory 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 and abstracts
- Conference reports
- Standard operating procedures
- Training and evaluation materials
EXPERIENCE
THERAPEUTIC AREAS
Cardiology, dentistry, dermatology, endocrinology, gastroenterology, genetics, 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, immunotherapy, 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