Clinical trial research agreement Agreed schedule 4 or 7 clause amendments
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1 Clinical trial research agreement Agreed schedule 4 or 7 clause amendments Medicines Australia and Medical Technology Association of Australia templates The sponsors in the table have agreed clauses for inclusion into Schedule 4 or 7 of the Medicines Australia Clinical Trial Research Agreements or the Medical Technology Association of Australia Clinical Investigation Research Agreements. Queensland Health Research Governance Office/rs have a copy of the agreed clauses. Sponsor Template Clinical Research Organisation () Version AbbVie Phase IV Phase IV April 2014 AbbVie Standard March 2013 AbbVie & Genentech Standard September 2013 Abivax SA Novotech Australia Pty December 2014 Acerta Pharma LLC Novotech Australia Pty December 2014 Alexion Pharmaceuticals Standard April 2014 Alexion Pharmaceuticals Phase IV April 2014 Allergan Inc Standard May 2014 Allos EMAS Pharma Pty July 2012 Amgen Australia Pty Standard April 2013 Amgen Australia Pty Standard August 2014 Amgen Australia Pty Standard December 2014 ANZ Breast Cancer Trials Group (ANZBCTG) ANZ Breast Cancer Trials Group (ANZBCTG) December 2014 ANZIC-Research Centre, Monash University CRG December 2013 (SPICE Study)
2 Aragon Pharmaceuticals Pty Pharmaceutical Research Associates (PRA) February 2015 Ardea Biosciences Novotech Australia Pty March 2013 Arena Pharmaceuticals Inc JAAD Enterprises August 2014 Clinical Network Services (CNS) February 2013 Quintiles Pty August 2011 ICON November 2011 INC Research Australia Pty February 2012 Astex Pharmaceuticals Pharmaceutical Research Associates (PRA) December 2014 Auspex Pharmaceuticals Inc INC Research Australia Pty September 2014 Australian Leukaemia & Lymphoma Group (ALLG) Australian Red Cross Blood Service CRG November 2012 CRG November 2014 (ARCBS Owned IP) Australian Red Cross Blood Service CRG November 2014 (Joint IP) Avid Radiopharmaceuticals Neuroscience Trials Australia February 2014 Bayer Australia Phase IV July 2013 Biogen Idec Phase IV November 2013 Biogen Idec Standard November 2013 BioMarin Pharmaceuticals Pacific Clinical Research Group September 2013 Biota Standard April 2013 Biotronik Australia Standard June 2012 Boehringer Ingelheim Pty Standard February 2015 Eli Lilly Parexel, Quintiles or Covance September 2014 Eli Lilly Phase IV September 2014 Eli Lilly Standard September 2014 EMR Associates Pty EMR Associates Pty October 2013 Clinical trial research agreement Agreed schedule 4 or 7 clause amendments March
3 F.Hoffman-La Roche Quintiles Pty March 2013 (GO27878) F.Hoffman-La Roche & Genentech Standard August 2014 Flexpharma Neuroscience Trials Australia November 2014 Fondazione Michelangelo Breast Cancer Clinical Trials Unit June 2013 GlaxoSmithKline Standard September 2014 (Novartis announcement only) Global Genomics Group LLC Barons Medical Consulting Pty November 2013 Idenix Pharma Inc Quintiles Pty July 2014 Incyte Corporation Medpace Australia Pty February 2013 inventive Health clinical inventive Health clinical April 2013 Ipsen Pty Phase IV January 2015 Janssen Research and Development PharmaNet Pty September 2013 Janssen-Cilag Pty Standard June 2013 Johnson & Johnson Pty Standard July 2013 Karyopharm Inc Novotech Australia Pty September 2014 Kyowa Hakko Kirin Pharma Inc Medpace Australia Pty July 2014 Leo Pharma Pty Standard December 2014 Lexicon Pharmaceuticals Inc INC Research Australia Pty May 2013 Lundbeck Standard February 2014 Marinus Pharmaceuticals Neuroscience Trials Australia November 2014 Merck Serono Australia Pty Merck Serono Australia Pty Standard December 2013 Quintiles Pty January 2014 Merck Sharp & Dohme Phase IV May 2014 Millennium Pharmaceuticals ICON December 2012 Clinical trial research agreement Agreed schedule 4 or 7 clause amendments March
4 Monash University CRG October 2013 (Balanced Study) New York University CRG April 2013 (ISCHEMIA Study) Population Health Research Institute (PHRI) CRG December 2014 Population Health Research Institute (PHRI) CRG TOTAL Study PTC Therapeutics PPD Australia Pty April 2013 Quintiles Pty Quintiles Pty April 2013 ( ABAC) Quintiles Pty Standard April 2013 (Std ABAC) Quintiles Pty Phase IV August 2014 Quintiles Pty Quintiles Pty November 2014 (Third Party) Regeneron Pharmaceuticals, Inc PPD Australia Pty January 2015 Rigel Pharmaceuticals Inc INC Research Australia Pty December 2014 Roche Products Pty February 2013 Roche Products Pty Standard February 2013 sanofi-aventis Phase IV October 2013 sanofi-aventis Standard September 2013 Servier Laboratories (Aust.) Pty Servier Laboratories (Aust.) Pty Standard April 2013 Standard January 2014 (QUALIFY Study) Shionogi Inc Medpace Australia Pty September 2013 Southern Star Research Southern Star Research January 2015 St. Jude Medical MTAA Standard July 2014 St. Jude Medical Standard July 2014 Stryker Australia Pty MTAA Standard August 2014 Sydney Local Health District CRG August 2014 (QLD version) Clinical trial research agreement Agreed schedule 4 or 7 clause amendments March
5 Takeda Development Centre Asia Pte. Quintiles Pty March 2014 TauRx Worldwide Clinical Trials September 2014 The George Clinical Pty The George Clinical Pty September 2014 The George Institute for Global Health The George Institute for Global Health The Princess Alexandra Hospital CRG October 2013 CRG November 2014 CRG July 2014 (Pomalidomide Study) UCB Australia Pty Standard July 2012 University of California CRG Neuroscience Trials Australia March 2013 University of Queensland CRG SMARRT Study Vertex September 2013 Washington University Quintiles Pty October 2013 Women's and Children's Health Network CRG July 2013 Clinical trial research agreement Agreed schedule 4 or 7 clause amendments March
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