Hammersmith Medicines Research (HMR)

HMR is a Contract Research Organisation (CRO). We specialise in phase 1 and early phase 2 studies. Our premises are 2300 square metres in size and contain 70 beds, laboratories, a pharmacy, offices and facilities for volunteers. We have 150 staff - 8 physicians, 35 nurses or nurse graduates, and 95 graduates or PhD. We have done over 400 studies since 1993. HMR is one of the largest CRO of its kind in Europe.

Our services include:

• Reviewing the client's pre-clinical research data, together with any relevant scientific and medical literature, and then advising on a study or programme of studies in humans
• Writing the study protocol
• Developing methods of assessing the efficacy of the new medicine
• Designing and producing the case report forms
• Writing the Informed Consent Form
• Application to the local or multi-centre Ethics Committee
• Recruiting and screening volunteers or patients
• Carrying out the study
• Repackaging and reconstituting investigational medicinal product
• Laboratory safety tests of blood and urine
• Data management and statistical analysis
• Pharmacokinetic analysis
• Integrated clinical, statistical and pharmacokinetic report

General
Most of our studies involve assessment of drug handling and effects in healthy volunteers or patients after oral, intravenous or topical administration. We have facilities for a wide range of types of study:

• First administration to man - single and repeated dose
• Pharmacodynamic studies - single and repeated dose, using established or new methods
• Safety and tolerability testing - single and repeated dose
• Pharmacokinetic studies - single and repeated dose
• Metabolic studies - 'cold' and radiolabelled
• Drug interactions - drug/drug; drug/food; drug/alcohol

Biotechnology studies
We have done studies with novel proteins, peptides, cytokines or vaccines, mainly produced by recombinant techniques, or genetically modified micro-organisms. Our premises are approved by the UK Health & Safety Executive for studies with genetically modified micro-organisms, types 1 and 2.

Pharmacodynamic studies
We have extensive experience of numerous methods of measuring actions of drugs on the human body, as follows:

Cardiovascular
• 41 beds with central ECG monitoring (SpaceLabs), including continuous electronic and hard copy ECG recording, arrhythmia detection, and facility to download BP, heart rate and temperature data.
• Telemetry (SpaceLabs); ECG monitoring of 16 channels by radio link throughout premises
• Microprocessor-assisted standard electrocardiography
• High-speed high-gain surface electrocardiography
• Manual measurement of QTc interval by digitiser
• Systolic time intervals
• Impedance cardiography
• Doppler aortic velography
• Laser Doppler flowmetry
• Forearm blood flow
• Hand venous reflex measurement
• Fingertip photo-plethysmography
• 24-h ambulatory ECG and blood pressure monitoring
• Bias-free measurement of blood pressure
• Exercise ECG
• Passive tilt testing
• Catecholamine and prostanoid agonist/antagonist studies

Central nervous system

• Psychomotor testing
• Co-ordination tests
• Cognitive function assessment
• Scopolamine model of dementia
• Analgesia assessment
• Body sway
• Saliva flow rate
• 5-HT1A receptor mediated function tests
• EEG
• PET (in collaboration with the Cyclotron Unit, Hammersmith Hospital)
• SPET (in collaboration with the Institute of Nuclear Medicine, Middlesex Hospital)

Respiratory

• Peak expiratory flow rate
• Minute volume
• Standard spirometry
• Computer-assisted spirometry
• Pulse oximetry (12 beds)
• End tidal pCO2
• Transcutaneous pO2
• Bronchoscopy and broncho-alveolar lavage
• Histamine, methacholine and AMP challenge
• Allergen challenge
• Nitric oxide
• Sputum analysis
• Acoustic rhinometry
• Leucocyte flow cytometry

Gastro-intestinal

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

Renal

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

Ocular

• Intraocular pressure by non-contact or applanation tonometry
• Slit lamp examination
• Pupillometry: video infra-red, photographic or twin hole methods

Haematological

• Bleeding time
• Platelet aggregometry
• Red blood cell deformability
• Coagulation studies
• 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
• Radioimmunoassay
• Drug screening (eg alcohol, benzodiazepines, cocaine, opiates, amphetamines, cannabis)

Pharmacokinetic analysis

• Derivation of all parameters
• Kinetic modelling

Analysis of drug concentrations
We collaborate with the Analytical Unit, St George's Hospital, London, a GLP-registered laboratory with a full range of analytical methods for assay of drug concentrations. Alternatively, we liaise with other companies that have or can develop validated assays using specialised techniques, such as LCMS-MS.

Data management, statistics, report writing and quality services
We manage, analyse and report data generated within or outside the company. We use SWAN, a commercial SAS-based data management system developed by Searle/Monsanto. SAS is our main software for statistical analyses. We prepare study reports in accord with ICH Guidelines or the client's standard operating procedures. We provide an independent quality service; we audit from source data to statistical output and from statistical output to the study report. We have an ISO 9001 quality management system based on GCP, comprising a quality manual, 17 quality system procedures, and 500 standard operating procedures.

Pharmacy
We have a GMP-compliant pharmacy to prepare and/or repackage investigational medicinal products for our phase 1 or 2 studies. We have experience of administration of drug substances via many routes: intravenous, intramuscular, subcutaneous, intradermal, transdermal, oral, buccal, intra-duodenal, intra-jejunal, rectal, intranasal, ocular, and by inhalation.

Analytical laboratory
We have a CAP-accredited and well-equipped pathology laboratory. We offer a full range of biochemistry and haematology safety tests, and urinalysis and other microbiology tests. Our range of specialised tests includes platelet aggregometry and FACS.

Resuscitation facilities
We have full facilities for cardiopulmonary resuscitation including cardiac defibrillation and endotracheal intubation. A physician fully trained in the use of these techniques is in constant attendance after the administration of new or potentially hazardous compounds. In addition, the Central Middlesex Hospital maintains a permanent, 24h/day Resuscitation Team which we can call at any time. Our wards are close to the Intensive Therapy and Coronary Care Units.

Our markets are worldwide. To date we have worked for companies in Austria, Belgium, Canada, Denmark, France, Germany, Holland, Hungary, Israel, Italy, Japan, Korea, Spain, Sweden, Switzerland, UK and USA. Our customers are large national or international pharmaceutical companies and smaller biotechnology or biopharmaceutical companies. Over 60% of our work is from companies outside the UK.

1994: RSA grant from the UK Department of Trade and Industry
1995: Rubicon Award for New Business of the Year
1998: The Queen's Award for Export Achievement
1998: Affiliate member of the Association of the British Pharmaceutical Industry (ABPI)
1999: Rubicon Award for Growing Business of the Year
1999: ISO 9001 accreditation
1999: UK Fast Track 100 company (one of the 100 fastest growing UK companies)
2002: The Queen's Awards for Enterprise: International Trade

• Dedicated team of 10 recruiters
• Special populations, eg elderly or post-menopausal women
• Patient volunteers for special studies, eg asthma, allergic rhinitis, herpes virus infection, benign prostatic hypertrophy, diabetes, male erectile dysfunction and migraine
• Internet-based system (TOPS) to prevent subjects from taking part in studies too frequently

Contact Information

Hammersmith Medicines Research (HMR)
Dr Malcolm Boyce
Central Middlesex Hospital
Acton Lane, London NW10 7NS United Kingdom
Phone: +44 (0)20 8961 4130
Fax: +44 (0)20 8961 8665
E-mail:

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