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Phase I – IV capability

 

The staff of the MEU are fully trained and experienced in the conduct of single-site and multi-site patient studies, and have knowledge of a wide range of therapeutic areas and are fully trained in EU and UK clinical trials legislation and ICH GCP. With a 36 bed inpatient facility and a large out-patient facility within a major teaching hospital site, the MEU is able to offer high quality studies, with recruitment rates and trial completion often well ahead of schedule.
 

The MEU has a bespoke clinical database known as I.C.A.R.U.S. This database holds both demographic and clinical information on over 6,000 volunteers. We can access protocol inclusion exclusion criteria through its query tool within minutes and produce realistic feedback to sponsors on the feasibility of a trial. The result of this dedicated function means that the MEU is frequently the top recruiter in the UK in both single centre and multi-centre studies. I.C.A.R.U.S. also tracks subjects as they progress through a trial and gives real time feedback on volunteer recruitment and progression.
 

MEU possesses a number of positive elements and services that go a significant way in providing clients with "added value". In addition, with MEU's partners, MEU Solutions can offer a full CRO service, encompassing: regulatory affairs, ethics applications, data management/monitoring, CRF production, statistics and medical writing, bio analytical services, and clinical pathology services.
 

Phase I-IV capability

  • 36 bed purpose built clinical trial unit based at Wythenshawe Hospital, Manchester, UK
  • Extensive experience of studies defining pharmacodynamic/pharmacokinetic relationships in healthy volunteers and patients
  • All routes of administration, including intravenous, subcutaneous, inhalation and novel drug delivery systems
  • MHRA Phase 1 Accreditation
  • MHRA Manufacturing Assembly Licence
  • Gene Therapy Import Licence
  • Full 24-hour emergency cover with access to ITU

Full package clinical trials

  • Regulatory affairs (including CTA applications)
  • Quality assurance, quality control and monitoring
  • Investigational medicinal product preparation and secondary manufacturing
  • CRF production
  • Data management
  • Statistics
  • Medical writing

Quality

  • Work to full ICH GCP
  • MHRA and Independent QA Inspected
  • Internal SOP system

Respiratory capability

  • Whole body plethysmography / DLCO
  • Impulse Oscillometry / Spirometry
  • Transfer factor
  • Bronchoscopy and bronchial biopsy
  • Induced sputum
  • Nasal challenge
  • Inhalational bronchial challenges of allergens or other mediators (ATP, methacholine, histamine, AMP, leukotriene D4, LPS)
  • 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, Cystic Fibrosis, Healthy volunteers and other therapeutic areas when required.

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

Cardiovascular capability

  • 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

 

MEU Database of volunteers

 

Asthma

 

The subject database includes over 4,500 asthmatic subjects of varied severity (from steroid naïve to high dose inhaled steroid patients). Lung function tests (including reversibility) have been performed on all these subjects in addition to a medical and therapeutic history. This enables searches to be made on specific patient groups for individual studies. The asthma database also has a large sub-group of subjects who smoke, enabling studies of the effect of smoking in asthma treatments.

 

COPD

 

Over 1,000 characterised patients with COPD/emphysema have been recruited to the database.

 

Rhinitis

 

The MEU has a cohort of rhinitis patients for inclusion in studies of seasonal rhinitis.

 

Cystic Fibrosis

 

We have a cohort of over 300 Cystic fibrosis volunteers

 

Healthy volunteers

 

A database of 6,000 healthy volunteers is available for Phase I studies or comparator groups for later phase studies. The database also includes a cohort of "healthy smokers" with small airway disease.

31 Jan 2017

Visit us at DIA Euromeeting

29th - 31st March at SECC, Glasgow

 

and BIO International Convention

19th - 22nd June in San Diego

 

11 Nov 2015

Sir Alex Ferguson opens new Bronchoscopy unit at MEU

 

2 Oct 2015

MEU-Partnership project (KTP008776) nominated for KTP Awards 2015

 

1 Oct 2015

Watch Professor Singh speaking about COPD Patients and the importance of reducing the risk of exacerbations at ERS 2015 in Amsterdam.

 

1 Oct 2015

Verona Pharma’s respiratory drug proves positive in study

 

25 Sept 2015

The new bronchoscopy unit at UHSM, funded by the MEU is now in operation allowing the MEU to increase its bronchoscopy capacity. The unit will be officially opened by Sir Alex Ferguson on Mon 9th November 2015

 

 

22 October 2014

The MEU and Knowledge Transfer Partnership work has been chosen as an example of excellence in the

"North West Innovation case book" - see page 19

 

24 June 2014

2014 World Asthma day

Listen to John Goddard, Volunteer Services Advisor, interview on Wythenshawe FM for World Asthma day

 

11 February 2014

MEU Clinical Physiology Manager receives John Coates award at ARTP conference gala dinner.

More....

 

11 May 2012

“The MEU are pleased to announce the completion of our new extension, expanding the total bed capacity from 18 to 36, increasing our out-patient facilities, doubling the size of the volunteer lounge and extending first floor offices.”

 

5 August 2011

The MEU is pleased to announce that we are now accredited with the ISO9001:2008 Quality Management Systems award.

 

7 November 2010

Wythenshawe Hospital COPD Day

Listen to Maggie Adu, Volunteer Services Advisor, talking about the COPD Day.

 

 

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