Experience

Business Process Simplification 
 Reduction and simplification of standard operating procedures
 Simplification of Clinical Study Report production process
 Simplification and increased world-wide accessibility to a global system

Training 
 Clinical research (GCP)
 Process implementation and orientation
 Team motivation and enlightenment
 Preparation for audit/inspection

Medical Writing
 Clinical Study Reports
 Patient Information Leaflets 
 Process Documentation
 Copy and website content

Clinical Research Management
 Managing clinical research department, including the set up and implementation of GCP
 Design and implementation of a clinical project management system
 Forecasting and managing clinical project budgets
 Training of CRAs in GCP and all aspects of clinical research
 Resource management within Clinical Operations and Biostatistics and Data Management 

Clinical Research
 International projects in Pharmaceutical companies and a Contract Research Organisation
 Identification of key investigators and liaison with clinical opinion leaders in many different therapeutic areas
 Design of product development plans and clinical research programmes
 Conduct of studies in all Phases I-IV and in Rx to OTC switch programmes
 Conduct of pharmacokinetic and pharmacodynamic studies with techniques including gastric pH measurement, induced cough and cold and gamma scintigraphy
 Assessment and use of CROs and development of preferred supplier relationships
 Writing of protocols, clinical reports, clinical expert reports, reviews and assessments

Therapeutic
 Oncology (colorectal, breast, prostate and lung)
 Infertility (in-vitro fertilisation)
 Analgesics (NSAIDs, paracetamol and cancer pain relief)
 Dermatology (acne, psoriasis, eczema)
 Gastro-intestinal (IBD, IBS, crohn’s disease, heartburn/reflux and indigestion)
 Respiratory Tract (asthma, cough, cold and sore throat)
 Cardiovascular (hypertension)
 Oral Care
 Nutritional Healthcare
 Anti-infectives (coldsores) 

Planning
 Wide ranging experience in drug development within the Pharmaceutical and Healthcare Industry
 Resource management and capacity planning for global Medical and Regulatory department of 100+ headcount
 Contingency planning and trade-off analysis
 Expert user of MS Project, Excel, TM1 and data-base reporting tools