Professional pharmaceutical services

Having worked in NHS acute medicine for 12 years, over 14 years early phase drug development and in MHRA Medical Assessor assessing all phases of clinical trials have given me extensive experience in my medical knowledge and in the field of Clinical Trials. With over 300 Early Phase studies as Principal Investigator/Sub Investigator I have covered virtually the whole therapeutic spectrum.

  • CNS
  • Anxiety/depression/psychosis
  • Parkinson’s
  • Dementia
  • Migraine
  • Epilepsy
  • Pain
  • Endocrine
  • Diabetes
  • Obesity
  • Growth hormone/sex hormones
  • Leptin
  • Cushing’s syndrome
  • Thyroid disorders
  • Parathyroid disorders
  • Hyperlipidaemia
  • Dermatology
  • Sensitisation/irritation
  • Skin blisters
  • Skin thickness
  • Transdermal absorption
  • Vasoconstriction
  • Immunology
  • Allergy
  • Immunosuppression
  • Monoclonal antibodies
  • Interferons
  • Cytokines
  • Specialist cell techniques
  • Cardiovascular
  • IHD
  • CCF
  • Platelet aggregation
  • Bleeding time
  • Endothelial assessment
  • Vasodilators
  • Infectious diseases
  • Antibiotics
  • Antimalarials
  • Antivirals
  • Respiratory
  • Asthma
  • COPD
  • Cystic fibrosis
  • Aspergillosis
  • Gastrointestinal
  • GERD
  • IBS
  • IBD
  • Hepatitis
  • Endoscopy studies
  • Urology
  • Benign Prostatic Hypertrophy
  • Ophthalmology
  • Eye as a marker for systemic drugs
  • Accommodation
  • Pupillometry
  • Saccadic movements
  • Pupillary oscillation
  • Primary Ophthalmology
  • Tear collection/PK
  • Local tolerance
  • Slit lamp

CLINICAL PHARMACOLOGY

  • Glucose clamp
  • Appetite control test meal lab model for obesity patients
  • Rating scales
  • Biomarkers
  • Cognitive function
  • Gamma scintigraphy
  • Pain Models including dental pain model
  • Wheals/flares/blisters
  • Histamine challenge test
  • Flow cytometry
  • Nausea
  • Opiates and antagonists

STUDIES
IN PATIENTS

  • Diabetes
  • Eczema
  • Psoriasis
  • Inflammatory bowel disease
  • COPD
  • Asthma
  • Benign prostatic hypertrophy
  • Obesity

Regulatory

  • Clinical/Therapy Area Overview
  • Expert Reports
  • MHRA Clinical Trial Application & Assessment Processes
  • Representation at meetings with Competent Authority (CA) including MHRA Scientific Advice meeting
  • Handling questions from CA

Training

  • GCP
  • General Medicine
  • Diabetes & Endocrinology
  • Pharmaceutical Medicine
  • Phase 1 Research Physicians
  • Faculty of Pharmaceutical Medicine PMST training & DPM Examination

Clinical Pharmacology & Other Studies

  • Feasibility
  • Clinical Development Plan
  • Advice regarding MHRA inspections
  • Advice regarding to any Early Phase CRO activities and clinic facilities
  • Advice on First in Human (FIH) studies
  • Advice on EAG (High risk) molecules
  • Biologicals
  • Vaccines
  • Pharmacodynamics and surrogate markers
  • Selection of CRO and Phase I unit and placing of studies
  • Ethics Committee submissions
  • CTA submissions
  • Protocol design and writing
  • Investigator brochure writing
  • DSMBs
  • Medical Monitoring
  • Bioavailability and bioequivalence
  • Interaction studies
  • ADME studies
  • Inhaled Device studies
  • Absolute Bioavailability/IV microtracer studies
  • Microdose studies
  • Scintigraphy studies
  • Regional Bioavailability (Enterion studies)
  • Toxicology review
  • 24 hour medical cover
  • Report & Document review
  • Access to
    • Clinical Writing
    • CRAs
    • Research Nurses
    • Data Management and statistics
    • Pharmacokinetics