Phase II – 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 ICH GCP. With a 18 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 5,000 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 we 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

• 18 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 Supplementary and Standard Accreditation
• MHRA Manufacturing Assembly 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 and impulse Oscillometry
• Transfer factor
• Bronchoscopy and bronchial biopsy
• Induced sputum
• Inhalational bronchial challenges of allergens or other mediators (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 and Healthy volunteers

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

MEU Database of volunteers

Asthma

 

The subject database includes over 3,000 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 1000 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 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.