RECENT PROJECTS

Course Developer & Trainer
Workshops for the European Medical Writers Association:

• Medical Writing for Healthy Volunteer Studies
• An Overview of Healthy Volunteer Studies

Manuscripts for high-impact journals

• New England Journal of Medicine
• Lancet Infectious Diseases
• Lancet Oncology
• Annals of Internal Medicine

Nonclinical & Clinical CTD Modules
Vaccines, hepatitis C, cancer (haematologic & solid tumours), orphan diseases, stem cell therapy, cystic fibrosis, idiopathic pulmonary fibrosis

Investigational Medicinal Product Dossiers & Investigator Brochures
Vaccines, hepatitis C, hepatitis B, cancer (haematologic & solid tumours), orphan diseases, tuberculosis

Clinical Study Reports (including Abbreviated CSRs)
Vaccines, cancer (solid tumours), immunotherapy, macular disease, monoamine oxidase inhibitor, ulcerative colitis, HIV, hepatitis B, tuberculosis

Protocols
Vaccines, solid tumors, malignant pleural mesothelioma, monamine oxidase inhibitor, peanut allergy

Development Safety Update Reports
Vaccines, hepatitis B

Regulatory Briefing Packages
Vaccines, acute opioid withdrawal, hepatitis B, tuberculosis, oral lichen planus, diabetes mellitus

Clinical Evaluation Reports
Skeletal fixation devices

Lay Summaries
Healthy volunteer bridging study, haematologic cancers

Results Postings (ClinicalTrials.gov & EudraCT)
Healthy volunteer bridging study, vaccines, haematologic cancers

Conference Report/Consensus Statement

• Controlling the HIV Epidemic with Antiretrovirals: Treatment as Prevention and Pre-Exposure Prophylaxis

Training Modules
Maternal and child health care curriculum in Cameroon

Standard Operating Procedures
Clinical and medical writing SOPs for a full-service CRO