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Hammersmith Medicines Research (HMR)

Company Type Services

Contact Information

Dr Malcolm Boyce
Hammersmith Medicines Research (HMR)
Cumberland Avenue
London NW10 7EW
United Kingdom
+44 (0)20 8961 4130
+44 (0)20 8961 8665 (fax)
mboyce@hmrlondon.com
www.hmrlondon.com

Contact Company

Company Overview

HMR is a Contract Research Organisation (CRO). We specialise in and can provide a full service for phase 1 and early phase 2 studies. Our premises are spacious (6000 m²) and have 145 beds, a sleep unit for polysomnography, endoscopy unit, recreational facilities for volunteers, offices, laboratories, and a pharmacy, including 2 aseptic suites and a radiopharmacy. We have 200 staff – 8 physicians, 35 nurses or nurse graduates, and 135 graduates or PhD. We have done over 630 studies since 1993. HMR is probably the largest CRO of its kind in Europe.

Services

Our services include:

  • Reviewing the client's preclinical data, plus any relevant scientific and medical literature, then advising on human studies
  • Designing the study and writing the protocol
  • Designing and producing CRFs
  • Writing the Informed Consent Form
  • Applications to Research Ethics Committees and regulatory authorities
  • Recruiting and screening volunteers or patients
  • Clinical procedures, from screening to follow-up
  • Specialised clinical methods
  • Manufacturing, assembling and importing investigational medicinal product
  • Generating the randomisation code and code breaks
  • Laboratory safety tests of blood and urine, and biomarkers
  • Data management and statistical analysis
  • Pharmacokinetic analysis
  • Clinical, statistical and pharmacokinetic reports
  • Auditing and quality assurance

Scope of Our Services

General

Most of our studies involve assessment of drug handling and effects in healthy volunteers or patients after oral, intravenous or topical administration. We offer 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 PD endpoints
  • Safety and tolerability testing - single and repeated dose
  • Pharmacokinetic studies - single and repeated dose
  • Umbrella protocols – such as single ascending dose, multiple ascending dose and food-effect
  • Metabolic studies - 'cold' and radiolabelled, including microdosing
  • Drug interactions - drug/drug; drug/food; drug/alcohol
  • Bridging studies

Biotechnology studies

We have done studies with novel proteins, peptides, monoclonal antibodies, biosimilars, 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 offer a wide range of methods of measuring actions of drugs on the human body:

  • Cardiovascular
    • 133 beds with central ECG monitoring (Spacelabs), including continuous electronic, and hard copy, ECG recording, arrhythmia detection
    • Telemetry (Spacelabs); ECG monitoring of 24 channels by radio link throughout premises
    • Microprocessor-assisted standard ECG
    • Impedance cardiography
    • Doppler aortic velography
    • Laser Doppler flowmetry
    • Forearm blood flow
    • 24-h ambulatory ECG
    • 24-h ambulatory blood pressure monitoring
    • Exercise ECG
    • Passive tilt testing
    • Catecholamine and prostanoid agonist/antagonist studies
    • Thorough QTc
  • Central nervous system
    • Psychomotor testing
    • Coordination tests
    • Cognitive function assessment
    • Scopolamine model of dementia
    • Analgesia assessment
    • Body sway
    • Saliva flow rate
    • 5-HT1A receptor mediated function tests
    • Functional MRI
    • EEG and polysomnography – 8 beds
    • PET (in collaboration with Imanova, Hammersmith 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
    • Exhaled NO assay
    • Sputum analysis
    • Leucocyte flow cytometry
    • Whole body plethysmography
  • Gastro-intestinal
    • Intragastric and oesophageal ambulatory pH monitoring (24 h)
    • Gastro-intestinal transit time
    • Entero test of intragastric pH and metabolites in bile
    • Intragastric infusion of drug
    • Intrajejunal drug administration
    • Faecal red blood cell loss (using chromium-51 labelled red cells)
    • Upper gastro-intestinal endoscopy
    • Pentagastrin- or histamine-stimulated acid secretion
    • Gastric emptying using paracetamol kinetics
  • Renal
    • Chromium-51 EDTA method for glomerular filtration rate
    • Iodine-125 Hippuran method for effective renal plasma flow
    • Urinary transferrin, microalbumin and a1-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: static & dynamic, by video infrared
  • Haematological
    • Bleeding time
    • Platelet aggregometry
    • Red blood cell deformability
    • Coagulation studies
    • Cytokine assay
    • Assay of red and white blood cell precursors
    • Flow cytometry
  • Dermatological
    • Transdermal bioavailability
    • Cutaneous irritancy and sensitisation
    • Extracellular fluid and skin drug pharmacokinetics
    • Histamine, 5-HT or substance P intradermal tests
    • Allergen tests

Analysis of drug concentrations

We collaborate with leading commercial units, including Analytical Services International’ (ASI), St George's Hospital, London, a GLP- compliant laboratory with a full range of analytical methods for assay of drug concentrations.

  • Gas chromatography
  • HPLC
  • ELISA
  • LC/MSMS
  • Radioimmunoassay

Pharmacokinetic analysis

  • Derivation of all parameters
  • Kinetic modelling

Data management, statistics, report writing and quality services

We manage, analyse and report data generated within or outside the company. We use:

  • ClinPlus, a SAS-based data management system;
  • SAS for statistical analyses; and
  • WinNonlin for pharmacokinetic analyses.

We prepare study reports in accord with ICH Guidelines or the client's standard operating procedures. Our independent quality assurance team audits trial data at each stage from source to study report. Our ISO 9001:2008 quality management system is based on GCP and GMP, and comprises a quality manual, 20 quality system procedures, and 850 standard operating procedures.

Pharmacy

Our GMP-compliant pharmacy manufactures non-sterile, sterile and radioactive IMPs. We have had MIA(IMP) since 2004, and are licensed for radiolabelled studies. We have 5 QPs named on the MIA (IMP).

Analytical laboratory

Our CAP-accredited, ultramodern pathology laboratory offers a full range of biochemistry and haematology tests, urinalysis, and an extensive range of biomarkers using methods that include platelet aggregometry and FACS.

Resuscitation facilities

We have full facilities for cardiopulmonary resuscitation including cardiac defibrillation. We have a 24-hour resuscitation team, resident medical officer, and emergency alarms throughout. Our wards are close to the Intensive Therapy and Coronary Care Units of Central Middlesex Hospital.

Markets and Customers

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.

Achievements

1998: The Queen's Award for Export Achievement

1999: ISO 9001:1994 certification (currently ISO 9001:2008)

1999: UK Fast Track 100 company (one of the 100 fastest growing UK companies)

2002: The Queen's Awards for Enterprise: International Trade

2002: College of American Pathologists accreditation

2003: Royal Pharmaceutical Society registration

2004: National Training Award

2004: Manufacturer's Authorisation for IMP

2008: MHRA Phase 1 Supplementary Accreditation

2013: CIR accreditation

Volunteers

  • Dedicated team of 25 recruiters, including 5 bilingual Japanese speakers
  • Special populations, eg elderly, post-menopausal women, Japanese volunteers for ‘bridging studies’
  • Patient volunteers for special studies, eg asthma, allergic rhinitis, COPD, IPF, Down’s syndrome, 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

Dr Malcolm Boyce
Hammersmith Medicines Research (HMR)
Cumberland Avenue
London NW10 7EW
United Kingdom
+44 (0)20 8961 4130
+44 (0)20 8961 8665 (fax)
mboyce@hmrlondon.com
www.hmrlondon.com

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