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The UK's Medicines for
Human Use (Clinical Trials) Regulations came into force on May 1st,
2004, to implement the provisions of the EU's Clinical Trials Directive
(2001/20/EC).
All clinical trials in man (patients and healthy volunteers) will
be subject to regulatory review and approval. The previous clinical
trial exemption (CTX) scheme will be replaced by Clinical Trial Authorisation
(CTA). The application for a CTA must be submitted to the Medicines
and Healthcare Products Regulatory Agency (MHRA) and may be made in
parallel with ethical review.
Applications for ethical review of clinical trials of medicinal products
must be made by first contacting the Central Allocation System. Then
the completed application form has to be sent to the appropriate Research
Ethics Committee, together with the protocol and all supporting documents.
If the application is valid, the ethical opinion of the Research Ethics
Committee will be delivered within 60 days. If clarification or further
information is required by the Research Ethics Committee, the decision
may be delayed. In a multicentre study, additional site-specific assessments
must be made at each site.
Under the new UK Regulations there will be a new UK Ethics Committee
Authority (UKECA) responsible for establishing, recognising and monitoring
Research Ethics Committees.
 Health
Care System |
The National Health
Service (NHS), which was created in 1948, provides healthcare
for all citizens and is funded from central taxes.
In 2000 the NHS Plan was published; it describes reforms and increases in funding which are planned for the next ten years in order to improve and modernise the NHS. |
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Facilities and services provided by ECRON in the UK |
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Clinical Trials Management
National Health Our credo "Be ahead of
guidelines" guarantees you the most advanced service
for your team! Continuous training of our staff - both office-based
and home-based employees - avoids the tendency to diverge in the
interpretation of our voluminous SOPs. We have to keep control,
because many people make up a team, and only one unified procedure
makes a good trial!
Monitoring to ICH Standard
In the UK we cooperate both with individual experienced investigational
sites and with site management organizations to ensure high standard
procedures. One of our cooperating SMOs comprises alone more than
600 GPs with approximately 1.5 million patients to choose from.
Computerized access is standard.
Office location
Our office is ideally located in the Docklands, London's most vivid
and creative new business area. Ten minutes by taxi from London
City Airport, which serves most European business centres, the most
important of them several times a day. We are walking distance from
the European Medicines Evaluation Agency (EMEA), to provide you
with conference facilities and direct personal access to the key
staff. In addition you can join the London Underground to travel
all over London. The next station of Dockland Light Rail is just
down the road.
Further Services Needed?
For further services such as Medical Writing, Statistics, truly
independent Quality Assurance etc, please refer to the relevant
pages of ECRON.
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| Local
Office/staff |
ECRON LTD
10-16 Tiller Road, Docklands, London E14 8PX, UK
Phone: +44 (845) 225 60 12 Fax: +44 (845) 225 60 13
Email: bd@ecronacunova.com
or contact QED Partnership
for further specialized service |
Authorities |
Medicines
and Healthcare Products Regulatory Agency
Central Office for Research Ethics Committees
Department of Health
National Health Service
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UNITED
KINGDOM 
