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UK Phase I/IIa CROs - The Challenges Ahead

The EU Clinical Trials Directive

The implementation of the EU Clinical Trials Directive across member states will undoubtedly bring about a 'levelling of the playing field' as Phase I/IIa contract research organisations (CROs) compete for early phase clinical trials from pharmaceutical and biotechnology companies. With the additional burden of the strength of the pound at present, Phase I/IIa CROs in the UK face increasing commercial competition from their European counterparts and those based in the US and Canada.

UK Phase I/IIa CROs are currently able to offer pharma and biotechnology companies - particularly those in North America - faster clinical trial 'start-up' times in the early development of their compounds, as these trials do not require notification or approval by the national regulatory agency.

The cost and time benefits (particularly for smaller start-up companies) has meant that the UK has had a distinct commercial edge in attracting such trials. Implementation of the EU Clinical Trials Directive will not only provide greater harmonisation across European member states in terms of ethical and regulatory processes and clinical trial supply manufacture, but will create a more level playing field between UK CROs and their European and North American competitors. As early phase trials in the UK will now require regulatory approval, a key commercial advantage has been removed.


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By Wayne Griffin, Managing Director of Acumen Pharmaceutical Services Ltd

Wayne Griffin is Managing Director of Acumen Pharmaceutical Services Ltd, an early phase product development CRO based in Manchester, UK. He has more than 20 years' experience of working in the pharmaceutical industry, gaining scientific and managerial experience spanning all aspects of clinical development within several companies.
After graduating from the University of Surrey in 1980 he undertook a PhD at the University of London's cardiothoracic unit at Brompton Hospital in London, where he conducted various clinical research projects in cardiology and respiratory medicine. Wayne was previously Director of Clinical Research at an international CRO, and co-founded Acumen Pharmaceutical Services Ltd in 1998.

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Wayne Griffin
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