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, cystic fibrosis, renal cancer, acute lymphoblastic leukaemia, idiopathic pulmonary fibrosis, orphan diseases, stem cell therapy

Investigational Medicinal Product Dossiers & Investigator Brochures
Vaccines, acute lymphoblastic leukaemia, hepatitis C, orphan diseases, solid tumors

Clinical Study Reports
Vaccines (pre- and post-exposure prophylaxis, treatment), prostate cancer, macular disease, monoamine oxidase inhibitor, ulcerative colitis, chronic hepatitis B

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

Development Safety Update Report
Vaccines

Regulatory Briefing Packages
Vaccines, acute opioid withdrawal,

Clinical Evaluation Reports
Skeletal fixation devices

Lay Summaries
Healthy volunteer bridging study

Results Posting
Healthy volunteer bridging study, vaccines

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