1. Whence a Journal…

   • Stephen P. Spielberg

   Editorial 30 December 2014 Pages: 669 - 670

2. Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials

   • Nicole Sheetz
   • Brett Wilson
   • Lawrence Florin

   Sponsored Special Section by TransCelerate BioPharma: Challenging the Value of Source Data Verification Open access 30 December 2014 Pages: 671 - 680

3. New Governmental Regulatory System for Stem Cell—Based Therapies in Japan

   • Akinori Hara
   • Daisaku Sato
   • Yasuyuki Sahara

   Global Perspective 30 December 2014 Pages: 681 - 688

4. Does the Essential Medicines Policy Succeed in China? Empirical Study on Rational Medicine Use in Primary Health Care Institutions

   • Shi Yin
   • Yan Song
   • Ying Bian

   Global Perspective 30 December 2014 Pages: 689 - 695

5. Insights Into the Decision Making of Advisory Groups to the Italian Medicines Agency

   • Michele Marangi
   • Silvia Miriam Cammarata
   • Luca Pani

   Global Perspective 30 December 2014 Pages: 696 - 701

6. Competitive Strategies for Japanese Clinical Trial Sites: A New Approach to Quality

   • Toshiyoshi Tominaga

   Global Perspective 30 December 2014 Pages: 702 - 708

7. Evaluation of the Gulf Cooperation Council Centralized Procedure: The Way Forward

   • Mohamed H. Al-Rubaie
   • Stuart R. Walker
   • Sam S. Salek

   Global Perspective 30 December 2014 Pages: 709 - 716

8. 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 Tanaka
   • Satoru Fukinbara
   • Yoichi M. Ito

   Global Perspective 30 December 2014 Pages: 717 - 723

9. Risk Evaluation and Mitigation Strategies With Elements to Assure Safe Use: Alignment of the Goals With the Tools to Manage Risk

   • Michael Cronin
   • Susan Berger
   • Paul J. Seligman

   Product Safety 30 December 2014 Pages: 724 - 733

10. 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. Bapatla
    • Philippe Close
    • Ramaswamy Valliappan

    Product Safety 30 December 2014 Pages: 734 - 740

11. Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND

    • Sundeep S. Sethi
    • Judith M. Kramer
    • José M. Vega

    Product Safety 30 December 2014 Pages: 741 - 748

12. Implementing Adjusted Imaging Metrics Within Roche With the Metrics Champion Consortium: Experiences and Outcome

    • Andrew McDonald
    • Gudrun Zahlmann

    Product Development and Innovation 30 December 2014 Pages: 749 - 761

13. The Life Cycle and Management of Protocol Deviations

    • Munish Mehra
    • Katharina Kurpanek
    • Margaret Gurian

    Clinical Trials 30 December 2014 Pages: 762 - 777

14. 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

15. Review of the Evolution of Medical Information in Light of Changes in the External Landscape

    • Suzana A. Giffin
    • Peter Baumeister
    • David Bowers

    Special Section on Medical Communications 30 December 2014 Pages: NP6 - NP14

16. Medical Information Services: How Are We Trending?

    • Poonam Bordoloi
    • Andrew Gažo
    • Conrad Verzosa

    Special Section on Medical Communications 30 December 2014 Pages: NP15 - NP21

17. Serialization: Benefits Beyond Regulatory Compliance

    • Mary Anne Greenberg

    Special Section on Medical Communications 30 December 2014 Pages: NP22 - NP27

18. The Impact of the Great East Japan Earthquake on Research Activity in a Disaster-Stricken Area

    • Hiroto Narimatsu
    • Yuya Sugawara
    • Masahiro Kami

    Letter to the Editor Open access 30 December 2014 Pages: NP28 - NP29