|
 |
European Pharmaceutical Contractor
|
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.
|
Read full article >>
|
|
 |
|
| Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | | |
|
|
 |
Industry Events |
 |
Small Scale Biomanufacturing – clinical trials, cell & gene therapies
18 September 2008, Clifton Pavilion, Bristol Zoo Gardens, Bristol
This one day conference, sponsored by bioProcessUK and organised by BioApproaches South West, will cover key, important topics relating to small scale GMP biomanufacturing.
More info >> |
|
 |
News and Press Releases |
 |
New PFA SonicLine® ultrasonic flowmeters
Flow measurement with ultrasound fast, precise, free from contamination The new PFA SonicLine® ultrasonic flowmeters assure precise measurement and control of chemical consumption and management of chemical stocks with high reliability. SonicLine® is also ideally suited for accurate batch and dosing processes with high reproducibility.
More info >> |
|
 |
