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 (5800 m²) and have 100 beds, a sleep unit for polysomnography, facilities for volunteers, laboratories, a pharmacy, including an aseptic unit and radiopharmacy, and offices. We have 150 staff – 8 physicians, 35 nurses or nurse graduates, and 95 graduates or PhD. We have done over 550 studies since 1993. HMR is the largest CRO of its kind in Europe.
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 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 offer a wide range of methods of measuring actions of drugs on the human body:
Cardiovascular
- 41 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
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
- EEG and polysomnography
- PET (in collaboration with the Cyclotron Unit, 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
- Acoustic rhinometry
- Leucocyte flow cytometry
Gastro-intestinal
- Intragastric and oesophageal ambulatory pH monitoring (24 h)
- Gastro-intestinal transit time
- 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 α1-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
- FACS
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
- Gas chromatography
- HPLC
- ELISA
- LC/MSMS
- 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 best commercial units, or 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.
Data management, statistics, report writing and quality services
We manage, analyse and report data generated within or outside the company. We use ClinPlus, a commercial SAS-based data management system. 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. Our ISO 9001 quality management system is based on GCP, & comprises a quality manual, 17 quality system procedures, and 700 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 3 QPs.
Analytical laboratory
OurCAP-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 defibrillationWe have a 24-hour resuscitation team, resident MO, and emergency alarms throughout. Our wards are close to the Intensive Therapy and Coronary Care Units of Central Middlesex Hospital.
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.
1998: The Queen's Award for Export Achievement
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
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
2010: CIR accreditation
