Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials Nicole SheetzBrett WilsonLawrence Florin Sponsored Special Section by TransCelerate BioPharma: Challenging the Value of Source Data Verification Open access 30 December 2014 Pages: 671 - 680
New Governmental Regulatory System for Stem Cell—Based Therapies in Japan Akinori HaraDaisaku SatoYasuyuki Sahara Global Perspective 30 December 2014 Pages: 681 - 688
Does the Essential Medicines Policy Succeed in China? Empirical Study on Rational Medicine Use in Primary Health Care Institutions Shi YinYan SongYing Bian Global Perspective 30 December 2014 Pages: 689 - 695
Insights Into the Decision Making of Advisory Groups to the Italian Medicines Agency Michele MarangiSilvia Miriam CammarataLuca Pani Global Perspective 30 December 2014 Pages: 696 - 701
Competitive Strategies for Japanese Clinical Trial Sites: A New Approach to Quality Toshiyoshi Tominaga Global Perspective 30 December 2014 Pages: 702 - 708
Evaluation of the Gulf Cooperation Council Centralized Procedure: The Way Forward Mohamed H. Al-RubaieStuart R. WalkerSam S. Salek Global Perspective 30 December 2014 Pages: 709 - 716
Current Practice in Japan for the Prevention and Treatment of Missing Data in Confirmatory Clinical Trials: A Survey of Japanese and Foreign Pharmaceutical Manufacturers Shiro TanakaSatoru FukinbaraYoichi M. Ito Global Perspective 30 December 2014 Pages: 717 - 723
Risk Evaluation and Mitigation Strategies With Elements to Assure Safe Use: Alignment of the Goals With the Tools to Manage Risk Michael CroninSusan BergerPaul J. Seligman Product Safety 30 December 2014 Pages: 724 - 733
Timeliness of a Signal Detection Process as a Component of Effectiveness Assessment in a Drug Safety Department of a Large Pharmaceutical Company: Review Over a 5-Year Period Kiran B. BapatlaPhilippe CloseRamaswamy Valliappan Product Safety 30 December 2014 Pages: 734 - 740
Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND Sundeep S. SethiJudith M. KramerJosé M. Vega Product Safety 30 December 2014 Pages: 741 - 748
Implementing Adjusted Imaging Metrics Within Roche With the Metrics Champion Consortium: Experiences and Outcome Andrew McDonaldGudrun Zahlmann Product Development and Innovation 30 December 2014 Pages: 749 - 761
The Life Cycle and Management of Protocol Deviations Munish MehraKatharina KurpanekMargaret Gurian Clinical Trials 30 December 2014 Pages: 762 - 777
Introduction to the Special Section on Medical Communications: Medical Communications Transformation Within the Emerging Health Care Landscape Lesley Fierro Special Section on Medical Communications 30 December 2014 Pages: NP5 - NP5
Review of the Evolution of Medical Information in Light of Changes in the External Landscape Suzana A. GiffinPeter BaumeisterDavid Bowers Special Section on Medical Communications 30 December 2014 Pages: NP6 - NP14
Medical Information Services: How Are We Trending? Poonam BordoloiAndrew GažoConrad Verzosa Special Section on Medical Communications 30 December 2014 Pages: NP15 - NP21
Serialization: Benefits Beyond Regulatory Compliance Mary Anne Greenberg Special Section on Medical Communications 30 December 2014 Pages: NP22 - NP27
The Impact of the Great East Japan Earthquake on Research Activity in a Disaster-Stricken Area Hiroto NarimatsuYuya SugawaraMasahiro Kami Letter to the Editor Open access 30 December 2014 Pages: NP28 - NP29