Services > Clinical Trials

Micro Medical Products in Clinical Trials

Micro Medical is a leading supplier of respiratory products to many of the world's largest pharmaceutical companies for regulatory and post-marketing clinical research trials.

The stability of the Micro Medical digital volume spirometer and the subsequent feature that regular calibration is not required prior to use, means that the instruments are particularly easy to use and provide reproducible results anywhere in the world. This is further supported by the ongoing use of MicroLoop turbine spirometers in the 5 year AstraZeneca START study in 32 countries (see www.starstudy.com), and the 1999 British Government Department of Trade and Industry mass COPD spirometry screening programme of former coal miners. To help ensure validation critical to your research, we are pleased to provide the following services:

  • Quality Assurance certification
  • Full bronchial challenge test protocol
  • Customised protocol- specific software
  • Investigator training
  • High quality technical support service

Quality Assurance

In support of your audit requirements for regulatory trials all Micro Medical spirometers hold certification to:

  • Independent test data to exceed ATS/ERS 2005 Standard recommendations
  • CE and FDA approval
  • ISO9001/EN46001 Quality System
  • ATS Waveform mechanical calibration checks and certificates pre and post trial

Bronchial Challenge Tests

SuperSpiro now features the most comprehensive Challenge Test programme available on a desktop unit, with protocols for Standard PC (methacholine), Standard PD (histamine), hypertonic saline, exercise and Mannitol challenge tests. The unit is easily customised to your own trial specific requirements and clearly takes the user through each stage of the testing procedure. Programme selection options include:

  • Alarm settings
  • Drug dosage
  • Dosage intervals
  • Different dosage calculation methods

Protocol Specific Software

Software customisations to match your exact protocol spirometry measurement and printout requirements can be done by Micro Medical on request. In addition, many of our products, including Micro DiaryCard, SuperSpiro, MicroLab 3500 and MicroLoop 3535 allow user flexibility with programming options available.

Investigator Training

We offer comprehensive training programmes by trained personnel for investigators and trial monitors, either at group investigator meetings or on a local level as required.

Technical Support Service

Micro Medical provides an in-house technical support team to co-ordinate international trials using our spirometers and supports trial monitors and investigators with up to date advice and help throughout a clinical trial. In addition, local service support is available through our network of dedicated distributors around the world.