RECENT PROJECTS

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

Manuscripts for high-impact journals

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

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

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, squamous cell carcinoma of the head and neck

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

Training Modules
Maternal and child health care curriculum in Cameroon

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