V INSIDE o l u CROs m in Asia e 2 0 N u m b Volume 20, Number 4 April 2011 e r 4 YOUR PEER-REVIEWED GUIDE TO GLOBAL CLINICAL T RIALS M ANAGEMENT appliedclinicaltrialsonline.com 1992–2011 ➤ GLOBAL TRIALS ACT Trials in the Middle East 2020 e Year c of Servi and North Africa G l o b al T Historical Overview: r i al s United Kingdom Trials A PPL I KKS Network Increases E D C Output in Germany L I N IC A L T R IAL Also in this issue S ■ Presidential Panel Considers Tighter Rules ■ European Union Provides Guidance ■ Natural Language Processing ■ Reducing Costs Through Technology Complete contents on pages 6 Ap ri l 2 0 1 1 PAREXEL International +1 781 487 9900 www.PAREXEL.com Right where you need us • REGULATORy eXPERTISe aCROSs iNTERNATIONAl bOUNDARIES PAREXEL knows scientific drug development from end to end. 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DEVELOPMENT FOR 2011: OUTSOURCING 9 Full day seminar for new BD professionals 9 New half-day workshops on managing prospects through the buying cycle and RELATIONSHIPS transparency among partners OPTIMIZING COLLABORATION BETWEEN EXTERNAL SERVICE 9 Unique panel of providers who are not PROVIDER BD AND PHARMA/BIOTECH SPONSORS CROs, focused on their concerns and challenges JULY 19-21, 2011 | HYATT AT THE BELLEVUE | PHILADELPHIA, PA 9 How to implement metrics to manage KEYNOTE: JOHN HUBBARD, PhD, FCP, Senior Vice President & Worldwide Head, risk and drive quality in clinical trials Development Operations, PFIZER, INC. 9 Partners revealing the inner structures WALL STREET FORECAST: ERIC COLDWELL, Managing Director – Healthcare Equity of their strategic partnerships Research, Distributors, Technology & CROs, ROBERT W. BAIRD & CO., INC. 9 Moving the BD focus to EU/ROW to CONSULTANTS’ VIEW OF PARTNERSHIP TRENDS: jump start development projects MIKE DEAGLE, Partner, and JOHN M. EBEID, Principal, PRTM 9 Rising to the challenge of global EXCLUSIVE TOWN HALL MEETING: feasibility through medical informatics Your opportunity to learn from the outsourcing 9 How Sponsors and Providers should strategies of 8 different sponsors! prepare for bid-defenses CONFERENCE SPONSOR: WITH SUPPORT FROM: 9 Negotiating a contract with fair and effective payment terms Register Today and save 15% of the Conference Registration Rate! Simply enter EXLACT when registering for either event! SAVE THE DATE! 7th Latin America Rave Reviews from Previous Latin America Clinical Trials Events Clinical Trials Conference I loved this event! Complete agenda with sponsor, CRO, legal representative and Site perspective. Addressed the critical issues Conducting Fast, Effi cient, and I cannot say how much I liked this! -Clinical Program Manager, P zer High Quality Trials in Latin America August 18-19, 2011 ~ Buenos Aires, Argentina It was a great day. It was really good to see how companies are working with methodologies and the results they are Why you can’t afford to miss this event; achieving. 1. A continued focus on regional regulatory timelines, protocol approvals -Senior Manager, Clinical Operations, Eli Lilly and special requirements 2. Driving good clinical quality standards in clinical trial activities CONFERENCE SPONSORS: 3. The legal / compliance aspects and managing risk of each department involved in the clinical trial 4. Due to a growing competitive landscape the sharp increase in clinical trial activity and patient recruitment For more information on sponsorships and exhibiting please contact: Jayson Mercado at 212-400-6236 or [email protected] 5. Controversial ethical issues when conducting trials in the region For more information on these events and to Register please visit: www.exlpharma.com or call 866-207-6528 APPLIED CLINICAL TRIALS VOLUME 20, NUMBER 4 COVER STORY GLOBAL TRIALS 44 Clinical Research 36 MENA: The Dawn of a New Era in the UK Rani Abraham Kerry Dyson and Due to a variety of factors, the amount of trials conducted in the Middle East Davide Garrisi and North Africa has increased. A brief history of clinical trials in the region, as well as a look at the current landscape. COMMENTARY CLINICAL TRIALS COMMUNITY 10 From the Editor 20 Years Partnering 14 News in Clinical Trials 56 Business and People Update Lisa Henderson 58 20 Calendar of Events View from Washington 50 Academic Strength Clinical Research Ethics, in Germany Oversight Draw Scrutiny MARKETPLACE Herbert Maier-Lenz Jill Wechsler 59 Advertiser Index 26 View from Brussels 60 Showcase The launch of the KKS Network has EU Regulation: Help 61 helped Germany increase its clinical From a Guiding Hand Marketplace trial output. Peter O’Donnell The KKS Network 30 Technology Viewpoint Kiel Mining for Words: Lübeck Hannover Berlin Münster The Case for NLP Witten-Herdecke Essen Halle Düsseldorf Wayne R.