Expertise

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

• Dedicated team of 15 bilingual Japanese nurses, graduates and recruiters
• Bilingual liaison manager for Japanese sponsors, with 15 years' experience of coordinating bridging studies
• Excellent track record in recruitment and retention of Japanese volunteers
• Dedicated website for recruiting Japanese volunteers
• Database of 4,500+ first generation Japanese volunteers
• Over 25 Japanese bridging studies
• PET and genotyping studies in Japanese volunteers
• Experience of bridging studies in Korean and Chinese subjects

Find out more about bridging studies.
ブリッジング試験に関する詳細はこちらから（日本語）.

• 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

• 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 Imanova). Click here to find out more about PET studies.
• CNS efficacy biomarkers in anxiety, depression, schizophrenia, cognitive disorders and obesity (in collaboration with P1vital). Click here to find out more about CNS studies.

• 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

• Digoxin, theophylline, warfarin
• Oral contraceptives
• Anticonvulsants
• Cytochrome P450 probes

• On-site endoscopy suite.
• Upper (esophagogastroduodenoscopy) and lower GI endoscopy (flexible sigmoidoscopy and colonoscopy) by in-house Medical Director (Kai Chan MD FRCS), who endoscopes regularly at Stoke Mandeville and Wycombe Hospitals, UK.
• Bronchoscopy – two recent studies, including aspiration of tissue and fluid samples.

• Over 150 first-in-man trials successfully completed – currently, about one-third of our trials are the very first administration of an IMP to humans
• Highly experienced principal investigator and chief medical adviser
• Robust procedures for risk assessment and dose escalation
• MHRA accreditation for first-in-man trials at all levels of risk
• Flexibility by design, to avoid unnecessary bureaucracy and delays

• 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)

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

For microdose studies, we work with Xceleron UK, who provide the accelerator mass spectrometry service: http://www.xceleron.com

Click here to find out more about microdosing.

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

Working with Imanova, Hammersmith Hospital, on PET studies. Click here to find out more about PET.

Thorough QT studies

Some people are born with prolonged QT interval, but others have prolonged QT interval thrust upon them - by medicines that affect cardiac repolarisation. QT prolongation predisposes to a disorganised heart rhythm called torsade de pointes, which can degenerate into ventricular fibrillation and death. In the last decade or so, several valuable drugs have been withdrawn from the market, or have had their use greatly restricted, because they can prolong QT interval and are associated with a risk of sudden death. Examples include prenylamine, terfenadine, astemizole, cisapride and sertindole.

Regulatory authorities now expect to see a thorough QT study of a new medicine - a rigorous assessment of its potential to prolong QT interval - even if preclinical work shows no sign of any problem. At HMR, we have successfully completed many definitive studies of the potential of new medicines to cause QT prolongation. We use industry-standard ECG machines to record high quality digital 12-lead ECGs, which can be coded and analysed ‘blind’ by the sponsor’s choice of specialist contractor, anywhere in the world. We capture the 24h ambulatory ECG (Holter) using the ELA SyneFlash system, which records continuous 12-lead ECG. SyneFlash allows continuous beat-to-beat automated measurement of QT interval and hourly estimation of mean QT, with immediate online analysis of relationships between QT and RR intervals. In our definitive QT studies, we use repeat-dose regimens to achieve steady state. Sometimes we include a CYP3A4 inhibitor, such as ketoconazole. We maximise safety by keeping the subjects resident in our wards: our 16-channel Spacelabs ECG telemetry system allows us to monitor them continuously throughout the research facility. We have done many QT studies of new and existing medicines.

Our track record shows that we can give sponsors the thorough QT study data that the regulators demand - safely, securely, and to strict timelines.

Click here to find out more about QT.

We offer a full service for phase 1 studies of radiolabelled products. We have long experience of studies with radiolabelled investigational medicinal products (IMPs) and non-IMPs: we've done more than 80 of them.

• ADME: ¹⁴C, ¹²⁵I and ³H (40 studies)
• PET: ¹¹C and ¹⁸F (30 studies)
• radionuclide probe: ⁵¹Cr, ^99mTc and ¹²⁵I (10 studies)
• microdose: ¹⁴C ‘light label’ (5 studies)

Resources:

• separate clinical and laboratory areas for studies of 'light label' and conventional doses of radionuclide
• dedicated radiopharmacy, including aseptic suite and validated sterilisation by filtration
• QC of radiolabelled IMP formulation by LSC
• stomacher, oxidiser and LSC for analysis of samples
• experienced staff: clinical, pharmacy, laboratory, QA, and Radiation Protection Adviser

Certification:

• ARSAC licence
• Environment Agency licence
• MHRA Accreditation
• MHRA Manufacturer’s Authorisation
• College of American Pathologists
• ISO 9001:2008 Quality System

• 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

• Peak expiratory flow rate
• Standard spirometry - Vitalograph Gold Standard
• Computer-assisted spirometry
• Nasal cannula 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

We have 2 sleep units, each with 4 bedrooms – some with an en-suite toilet and shower; others (see right) with facilities close by. Other features include:

• high-level sound-proofing, with acoustic boards, acoustic tiles and 10 cm thick fibre insulation
• no windows
• an entrance lobby, to maintain sound- and light-proofing when entering the room
• remote-controlled air-conditioning, and ventilation
• electrical trunking with separate channels for mains and low-voltage cables
• shielding of all mains cables, and wooden beds, to prevent electromagnetic interference
• infra-red light, and video camera
• controlled light for <5 lux waking environment
• microphone
• external port for remote intravenous blood sampling
• Embla N7000 polysomnography system (PSG) with:
  • EEG, EOG, ECG and EMG electrodes and leads
  • oximeter
  • respiratory effort
  • body position
  • nasal cannula
  • thermistor
  • snoring sensors

Each acquisition PC is protected by an Uninterruptable Power Supply (UPS), and stores data on mirrored RAID hard drives. We copy the data across the network to our file server, which we back up every night. Then we copy it again to a review PC where we process it before copying the final version to external media (eg CD/DVD) or sending it to a sponsor across the internet (eg WWW/FTP).

PSG equipment is validated in accordance with 21 CFR part 11. We have trained staff, including a PSG expert who has worked with 3 central sleep-scoring providers, and we have links with academic units experienced in sleep research.
We work according to AASM-recommended technical standards, to produce data acceptable for peer-reviewed publication and regulatory approval.

Click here to find out more about sleep studies