ProActive Consulting


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

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

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) 

 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