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European Pharmaceutical Contractor
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Cardiac safety has become the number one reason for drug withdrawals and labelling changes during the past several years. This has resulted in greater regulatory scrutiny for all new compounds and greater concern among pharmaceutical companies in regard to the potential effect of their compounds on cardiac safety. One of the outcomes of this focus was the ICH E14 document, which provided guidance on the conduct of a dedicated ECG study which many term the ‘thorough QT (TQT) trial’ (1). These trials are generally conducted after proof of concept has been completed and employ digital and centralised ECGs as described in E14. However, although almost all TQT trials are centralised, only approximately 20 to 25 per cent of all other clinical research (Phases I-IV) trials use centralised ECG analyses. |
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Industry Events |
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Clinical Trials in Latin America
9-10 September 2010, Lima, Peru
CBI’s Conference on Clinical Trials in Latin America, being held 9–10th September 2010 in Lima, Peru brings together key stakeholders involved with clinical trials in Latin America. Latin America is an increasingly desirable location for running clinical trials, and it is important for those involved to collaborate with colleagues and industry counterparts regarding the challenges of developing, executing and completing clinical trials in Latin America. This is a unique opportunity for pharmaceutical executives in Latin America to hear from key regulatory officials, pharmaceutical leaders, CROs and sites on how all stakeholders in the clinical process can ultimately achieve desired results.
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News and Press Releases |
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ClinTec International
ClinTec International, a global Clinical Research Organisation (“CRO”) announces a financial and strategic partnership with Elephant Capital Plc., an AIM market listed private equity firm. With an investment of £8 Million GBP, Elephant has acquired a significant minority stake in ClinTec. Through this investment, Elephant has entered the attractive clinical research base, where ClinTec operates as a global provider of outsourcing solutions addressing the drug development lifecycle. Managing Partner of Elephant Capital LLP, Gaurav Burman, and Non-Executive Director of Elephant Capital Plc, James Hauslein, have also made personal co-investments in this transaction.
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