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 1 to 4, local and global studies with invesgational and marketed drugs, immunotherapies, biologics, gene therapy, medical devices, diagnostics and comibination products in different therapeutic indications (including but not limited to CNS, oncology, anti-infective diseases eg, COVID-19, dermatology, endocrinology, metabolic disorders, respiratory diseases, gastrointestial and nephrology) for different clients (including large pharmaceutical, medical device, diagnostic and biotech companies)
- Clinical Study Reports (ICH E3 and abbreviated formats) for Phase 1 to 3 studies with different products (pharmaceuticals, biologics, immunotherapies, devices, vaccines and combination products) in various therapeutic areas (oncology, CNS, women's health, endocrinology/metabolic/GI disorders, pulmonary/respiratory, dermatology, anti-infective - vaccine, BA/DDI/food-effect studies in healthy subjects)
- Investigator brochures for drugs/biologics/immunotherapies (CNS, oncology, hematology, autoimmune, food allergy, various orphan designations, endocrinology/metabolic/GI disorders), combination products (osteoporosis, osteoarthritis, endocrinology), medical devices (CVS, obesity, fecal incontinence, imaging, GI) and in vitro diagnostic kits (anti-infective) and IMPD for EU CTA (women's health)
- Briefing packages (FDA/EMA; dermatology, wound management, GI/metabolic disorders, oncology and CNS orphan indications) and FastTrack applications & Breakthrough Designation applications (oncology)
- Clinical modules 1.20, 2.2, 2.5, 2.7.2, 2.7.3, 2.7.4, 2.7.6 for US IND/NDA and EU MAA and US IND Annual report (Modules 1.13.2 to 1.13.9) using CTD format (wound management, oncology, endocrinology/metabolic/GI disorders, autoimmune, food allergy, nephrology and dermatology) /li>
- Orphan drug designation application for US and EU (CNS, oncology, dermatology, hematology, auto-immune diseases)
- Development Safety Update Reports - initial and annual update (oncology, GI/metabolic disorders and CNS) & annual safety reports (oncology)
- Annual Safety Reports for phases I-II studies in oncology for a mid-size pharmaceutical company
- Risk Management Plans (RMP) for EU, Canada and Australia submissions (oncology, CNS, insomnia/sleep disorders, pain management, dermatology, GI/metabolic disorders and respiratory) for new & approved products
- Literature review for metabolic disorders and blood disorders
- Integrated Summary of Safety for a multinational pharmaceutical client (indication: Alzheimer's disease).