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

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

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

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