Clinical Capability
At Synairgen we have a dedicated team of respiratory specialist doctors and nurses. This clinical team conducts the company’s clinical trials which are either:
- Drug trials (CTIMP Clinical Trials of Investigational Medicinal Products) - when the volunteer takes a drug to establish safety and/or efficacy (for example - the interferon beta programme); or
- Non-drug trials (Non-CTIMP) - which do not involve the volunteer taking a drug (for example the Biobank programme).
All clinical trials conducted by Synairgen follow The Medicines for Human Use (Clinical Trial) Regulations 2004 and also The Medicines for Human Use (Clinical Trial) Amendment Regulations 2006 which transpose the EU GCP Directive into UK law. These regulations help to ensure that the rights, safety and well being of clinical trial subjects are protected.
Prior to starting any clinical trial the studies have also been through an approval process where they are approved by a variety of regulatory authorities such as MHRA (Medicines and Healthcare products Regulatory Agency) and Ethics committees.
Who can take part in Synairgen’s Clinical Trials?
Anyone who would like to can volunteer to take part in one of Synairgen’s Clinical Trials.
Each Clinical Trial requires different types of volunteers:
- Volunteers who have Asthma
- Volunteers who have COPD
- Healthy controls (volunteers without asthma or COPD)
Some of the tests and procedures that are involved in the Clinical Trials include:
- Lung function testing
- Skin allergy testing
- Methacholine challenge
- Blood sampling
- Sputum induction
- Bronchoscopy
The safety and well being of volunteers during any of Synairgen’s Clinical Trials is of the utmost importance to us. We take our time to get to know the volunteers and are able to offer them support and guidance regarding their asthma and COPD whilst they are with us. |