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About CCRA

Medicines Evaluation Unit Limited
The Langley Building
Southmoor Road
Wythenshawe
M23 9QZ

Tel: +44 (0)161 946 4050
Fax: +44 (0)161 946 1459

Web: www.meu.org.uk


The Medicines Evaluation Unit is based in Manchester, United Kingdom and specialises in performing clinical trials from Phase I through to IV, our core skill area being in Respiratory Medicine. Our facilities are located within the Wythenshawe Hospital NHS site. This allows us the advantage of access to the hospital’s specialist support services, therefore we are ideally situated to perform early phase exploratory studies.

The staff at the MEU are fully trained and experienced in the conduct of single-site and multi-site studies, and have knowledge of a wide range of therapeutic areas. With our purpose built 18 - bed in-patient facility, our high level of technical expertise and fast recruitment rates we are able to offer trial completion often well ahead of schedule.

The MEU has an outstanding reputation for performing high quality clinical research complying with ICH GCP. The Unit has also undergone favourable inspection by the MHRA (UK regulatory authority) and holds an MHRA Manufacturing Assembly Licence.

Group Sector

  • Phase I-IV Capability
  • Clinical trials phase I – IV
  • Core skill area respiratory medicine
  • Based on the Wythenshawe Hospital site (an NHS teaching hospital based in Manchester, UK) with full 24-hour emergency cover and access to ITU
  • Extensive experience of studies defining pharmacodynamic/pharmacokinetic relationships in healthy volunteers and patients
  • 18 beds, Laboratories and Pharmacy (MHRA Manufacturing Assembly Licence)
  • Experienced Medical and Clinical teams
  • Large database of Healthy, Asthma and COPD volunteers
  • All routes of administration, including intravenous, subcutaneous, inhalation and novel drug delivery systems
  • Experienced Principal Investigator’s in all phases of clinical trials from First-into-Man/ Patient and Phases I-IV

Quality

  • Work to full UK Statutory Instrument 2004 No. 1031 (which includes ICH GCP)
  • MHRA and Independent QA inspected
  • Internal SOP system
  • Dedicated Quality team

Full Package Clinical Trials (together with our partner ICON)

  • Regulatory Affairs (including CTA applications)
  • Ethics approvals
  • Quality Assurance, Quality Control and monitoring
  • Investigational medicinal product preparation and secondary manufacturing
  • CRF production
  • Data management
  • Statistics
  • Medical writing
  • Bioanalytical (GLP-compliant) and Clinical pathology (UKAS accredited laboratories)

Respiratory Capability

  • Whole body plethysmography and impulse oscillometry
  • Transfer factor
  • Bronchoscopy and bronchial biopsy
  • Induced sputum
  • Exhaled breath condensate
  • Exhaled nitric oxide
  • Various Exercise Challenge protocols
  • A range of drug delivery capabilities
  • Access to an extensive patient database of Asthma, COPD and Healthy Volunteers
  • Inhalational bronchial challenges of allergens or other mediators (methacholine, histamine, AMP, leukotriene D4)

Pharmacodynamic Capabilities

  • Induced sputum – cell counts, supernatant protein analysis, PCR
  • Exhaled breath measurements (nitric oxide and condensates)
  • Whole blood cell culture and flow cytometry
  • Lung cell molecular biology using clinical samples to assess changes in immune function
  • Blood pressure and ECG recording and evaluation
  • QT interval and dispersion measurement
  • 24-hour out-patient blood pressure monitoring
  • 24-hour high-dependency monitoring of in-patient studies
  • Holter monitoring
  • Telemetry

Subject Recruitment

  • Dedicated subject recruitment department
  • Bespoke database holding screening data, study feasibility and recruitment information
  • GP Development Nurse recruiting specific disease populations for individual studies
  • Dedicated ‘recruiter’ allocated to each study

Subject Database

  • Over 3000 asthmatic volunteers of varied severity (from steroid naïve to high dose inhaled steroid patients)
  • Information on lung function tests (including reversibility), medical and therapeutic history held for each patient to enable database searches to be made on specific patient groups for individual studies
  • Over 500 COPD/Emphysema volunteers
  • Ongoing recruitment of rhinitis patients for inclusion in studies of seasonal rhinitis
  • Over 1000 healthy volunteers (including ‘healthy’ ex and current smokers) available for Phase 1 studies or comparator groups for later phase studies

Geographical Area

  • UK

Contact

David Rogers, Director of Operations
Liz Batty, Clinical Research Manager


CCRA is a not-for-profit organisation originally founded to represent independent clinical research contractors and allied industries.