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Trials in the Middle East and North Africa 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. We complement your capabilities with • PHASe I–IV cLINICAl sERVICEs fOr yOUr iNDICATION, our strategic insight, deep scientific knowledge, and compound, and patient population tactical expertise—providing you support and guidance • TECHNOLOGy aLIGNEd to aCCELERATe dEVELOPMENt to secure strategic advantage. ANd mAXIMIZe ROI • MARKEt aCCESs sTRATEGy aNd cOMMUNICATIONs to rEACh With nearly 30 years of experience and 10,000 your markets and achieve peak revenue quickly professionals in more than 50 countries, we provide the precise fit of expertise when, where and how you need it. Look for PAREXEL at: DIA Annual Meeting CHICAGo, IL JUNe 19 – 23, 2010 APPLIED CLINICAL TRIALS Editorial Offices 485 Route 1 South, Building F, First Floor, Iselin, NJ 08830 USA www.emedcareers.com +1 (732) 346-3080 fax: +1 (732) 596-0003, www.appliedclinicaltrialsonline.com EDITOR-IN-CHIEF Lisa Henderson, [email protected] MANAGING EDITOR Timothy Denman, [email protected] ASSISTANT EDITOR Kayda Norman, [email protected] CORPORATE ART DIRECTOR Jerry Lehman, [email protected] ART DIRECTOR Dan Ward, [email protected] EUROPEAN EDITOR Philip Ward, [email protected] PO Box 114, Deeside CH5 3ZA, UK +44 1244 538 583 WASHINGTON EDITOR Jill Wechsler +1 (301) 656-4634 fax: +1 (301) 718-4377 Sales Offices VP & GENERAL MANAGER PHARMA/SCIENCE GROUP David C. Esola PUBLISHER AND EUROPEAN SALES Wayne K. 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All color separations, proofs, and Are you a clinical research specialist film produced by Advanstar’s Scanning and Digital Prepress Departments. looking for a new challenge? Then look no further than emedcareers.com. President, Chief Executive Officer Joe Loggia Executive Vice President, Finance & As a member of the pioneering Jobsite Chief Financial Officer Ted Alpert Executive Vice President, Corporate Development Eric I. Lisman Chief Administrative Officer Tom Ehardt Vice President, Chief network, we have thousands of constantly Technology Officer J. Vaughn Vice President, Electronic Media Group Mike Alic updated job opportunities available Vice President, Media Operations Francis Heid Vice President, Human Resources Nancy Nugent Vice President, General Counsel Ward D. Hewins, Executive Vice online - and one of those could be President, Pharma/Science Group Ron Wall Applied Clinical Trials does not verify any claims or other information appearing in any of just right for you. the advertisements contained in the publication, and cannot take any responsibility for any losses or other damages incurred by readers in reliance on such content. ACT wel- comes unsolicited articles, manuscripts, photographs, illustrations and other materials but cannot be held responsible for their safekeeping or return. Advanstar Communications provides certain customer contact data (such as customers’ names, addresses, phone numbers and email addresses) to third parties who wish to pro- mote relevant products, services, and other opportunities which may be of interest to you. If you do not want Advanstar Communications to make your contact information available to third parties for marketing purposes, simply call toll-free 866-529- 2922 between the hours of 7:30 am and 5 pm CT and a customer service representative will assist you in removing your name from Advanstar’s lists. Outside the U.S., please phone 218-740-6395. 4 APPLIED CLINICAL TRIALS appliedclinicaltrialsonline.com April 2011 PRESENTS TWO MUST ATTEND EVENTS: THE ONLY EVENT THAT FOCUSES ON BUSINESS DEVELOPMENT’S ROLE IN THE OUTSOURCING PROCESS, FROM INITIAL PROSPECTING TO LONG-TERM 3rd Annual RELATIONSHIP MANAGEMENT EFFECTIVE BUSINESS NEW! 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.
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