Phase 1

• First time in humans
• Pharmacokinetics
• Pharmacodynamics
• Radiolabelled compounds
• Positron emission tomography
• Microdosing
• Drug interactions
• Biotechnology
• Special groups:
  • elderly
  • post-menopausal
  • genetic polymorphisms

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Phase 2

Proof-of-principle

• Asthma
• Allergic rhinitis
• Diabetes
• Migraine
• Angina
• Prostatic hypertrophy
• Male erectile dysfunction
• Herpes infection
• Pre-menstrual syndrome

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Expertise

Products studied

• Conventional pharmaceuticals
• Biotechnology
• Proteins, peptides, cytokines
• Vaccines
• Genetically modified micro-organisms
• Anti-sense compounds

Pharmacodynamics

Cardiovascular

• Central ECG monitoring (SpaceLabs) on all beds
• Telemetry (SpaceLabs) throughout premises
• 12-lead ECG with electronic transfer capability
• High-speed high-gain surface ECG
• 24-h ambulatory 12-lead ECG and blood pressure monitoring
• Exercise ECG
• Passive tilt testing
• Systolic time intervals
• Impedance cardiography
• Doppler aortic velography
• Laser Doppler flowmetry
• Forearm blood flow
• Hand venous reflex measurement
• Fingertip photo-plethysmography
• Catecholamine and prostanoid agonist/antagonist trials
• Thorough QT

Find out more about thorough QT trials.

Central nervous system

• Psychomotor tests
• Coordination tests
• Cognitive function assessment
• Scopolamine model of dementia
• Analgesic assessment
• Body sway
• Saliva flow rate
• 5-HT1A receptor mediated function tests
• EEG
• Positron emission tomography (in collaboration with Hammersmith Imanet)

Find out more about PET trials.

Respiratory

• Peak expiratory flow rate
• Standard spirometry - Vitalograph Gold Standard
• Computer-assisted spirometry
• Lung volumes by helium dilution
• CO transfer factor
• Minute volume
• Pulse oximetry on all beds
• End tidal pCO₂
• Transcutaneous pO₂
• Bronchoscopy and broncho-alveolar lavage
• Histamine, methacholine and AMP challenge
• Allergen challenge
• Nitric oxide
• Sputum analysis
• Acoustic rhinometry

Gastrointestinal

• Intra-gastric and oesophageal ambulatory pH monitoring (24-h)
• Pentagastrin- or histamine-stimulated acid secretion
• Gastro-intestinal transit time
• Intra-gastric drug infusion
• Intra-jejunal drug administration
• Faecal red blood cell loss (using ⁵¹Cr-labelled red cells)
• Upper gastro-intestinal endoscopy
• Ambulatory gastric emptying using caesium iodide detector, ^99mTc radiolabelled meal and gamma camera
• Gastric emptying using paracetamol kinetics
• Gall bladder scintigraphy using ^99mTc radiolabelled HIDA (in collaboration with Radiological Sciences Unit, Hammersmith Hospital)

Renal

• ⁵¹Cr - EDTA method for glomerular filtration rate
• ¹²⁵I - Hippuran method for effective renal plasma flow
• Urinary transferrin, microalbumin and alpha-1-microglobulin to assess potential nephrotoxicity
• Urinary enzyme assay - NAG
• Renin and angiotensin assessments

Ocular

• Non-contact tonometry
• Goldmann applanation tonometry
• Slit lamp examination
• Photographic or twin-hole static pupillometry
• Infrared static and dynamic pupillometry

Haematological

• Bleeding time
• Platelet aggregometry
• FACS analysis
• Red blood cell deformability
• Coagulation trials
• Cytokine assay
• Assay of red and white blood cell precursors

Dermatological

• Transdermal bioavailability
• Cutaneous irritancy and sensitisation
• Extracellular fluid and skin drug pharmacokinetics
• Penile sensitivity
• Histamine, 5-HT or substance P intradermal tests
• UV erythema challenge tests
• Allergen tests

Analysis of drug concentrations

• Gas chromatography
• HPLC
• EMIT
• LC/MS/MS
• Radioimmunoassay
• Drugs of abuse

Radiolabelled

• Licence for radiolabelled trials
• Radiation Protection Supervisor
• ADME trials
• Microdosing trials

Drug-drug interaction

• Digoxin, theophylline, warfarin
• Oral contraceptives
• Anticonvulsants
• CYP3A4 inhibitors

Find out more about drug-drug interaction.

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Finding Volunteers

• Dedicated team of 10 recruiters
• Databases of
  1. young
  2. elderly
  3. post-menopausal
  4. patients, eg asthma, migraine, diabetes

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Analytical laboratory

• College of American Pathologists (CAP) accredited
• National External Quality Assurance Scheme (NEQAS) & CAP proficiency testing
• Experienced staff
• Full range of automated equipment
• Validated laboratory computer system (TLIMS)
• Electronic data transfer as required by sponsor
• Coagulation
• Immunochemistry
• Point-of-care tests

View a plan of the HMR lab.

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Quality Services

ISO 9001 accredited since 1999

• Internationally recognised standard
• Quality manual
• Quality system procedures
• Over 400 SOPs
• Regular internal and supplier audits

QC, QA and auditing pre- and post-trial:

• Protocol, information and consent form, CRF, report
• Master file
• Databases
• Statistical tables
• Facilities audit every 6 months
• Subcontractor audits every 2 years
• Audit of validation of computerised systems
• Regular calibration and maintenance of equipment

For more information, download our Quality Services brochure for viewing with Adobe Acrobat.

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Data Management

• SAS-based system, SWAN 2
  1. licensed from Searle Monsanto
  2. rapid design of each database
• Data management plan
• Review of CRF before data entry
• Double data entry by 2 people
• Manual and computerised validation checks
• QC at each stage
• QC report available to sponsor
• Coding by MedDRA or specified dictionary
• Export database in SAS or other format
• Laboratory data to specification of sponsor
• Validated systems ensure security of all electronic data

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Statistics

• Statistical input to trial protocol
• Power and sample size calculation
• Randomisation code generation
• Statistical analysis plan
• Experienced SAS users
• Statistical analysis, listings and tables using fully validated SAS programs
• Pharmacokinetic analysis: WinNonLin

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Medical Writing

• Protocol
• Investigator's brochure
• Ethics committee application
• CTA application
• CRF
• Interim report
• Pharmacokinetic report
• Statistical report
• Integrated clinical report (ICH compliant)
• Abstract or manuscript for publication

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