Phase IV Services & Products

11. Strategic Outsourcing Often Means Combining CROs 3/4/2013

    Functional CROs have expertise in a specific area, but offer a limited range of products. Full-service CROs offer a complete range of services but may not be fully integrated. Strategic outsourcing may now require you to combine them.

12. How Registries Can Close Peri-Approval Info Gaps Left By Clinical Trials 11/29/2012

    Marketing managers are increasingly recognizing registries as a marketing strategy to close info gaps left by clinical trials.

13. Comment On Biopharmaceutical Classification System And Formulation Development 10/26/2012

    This is the first installment in a series of articles that will provide an overview of an area of potential interest to the readers of Pharmaceutical Online and Outsourced Pharma. By Mark Mitchnick, MD, and Robert W. Lee, PhD

14. A Chief Medical Officer's Perspective On Selecting A CRO 5/14/2012

    Santosh Vetticaden, Ph.D., M.D. is a drug development professional with over 20 years of experience spanning large pharma and biotech across multiple therapeutic areas. He has been involved in trials from Phase I-Phase IV and has been extensively involved in the design, planning, and implementation of global trials. By Rob Wright, Chief Editor, Life Science Leader magazine

15. Industry Insights From PAREXEL Chief Operating Officer Dr. Goldberg 4/10/2012
    Over the past several years, the biopharmaceutical industry has been preparing for many blockbusters to come off patent. Facing the difficulty of replacing that revenue stream the industry’s focus in the emerging niche-buster era has centered on how to make R&D more efficient, including in the management of R&D dollars. By Rob Wright, Chief Editor, Life Science Leader magazine
16. Industry Trends From A Twenty Year CRO Veteran 4/5/2012
    Steve Powell is the EVP for PRA, a global clinical research organization (CRO) providing service through all phases of clinical development, which has supported 3,100 clinical trials in more than 80 countries. By Rob Wright, Chief Editor, Life Science Leader magazine
17. Insights And A Peek Into The Future For PRO & ePRO 12/12/2011
    PHT Corporation’s U.S. PRO & ePRO Congress, held in Boston Nov. 9-10, shared electronic patient reported outcome (ePRO) adoption growth numbers, discussions of new regulatory guidance, actionable information that can ease site and study subject burden from ePRO, PRO and ePRO in post-approval, and lingering reasons for sponsor reluctance to adopt ePRO. By Sara Gambrill
18. C-Path And The Predictive Safety Testing Consortium: Working To Qualify Safety Biomarkers For Preclinical Use 9/29/2011

    Safety liabilities are a major cause of attrition during drug development. Adverse drug reactions resulting in post-approval withdrawal of a medicine cost the pharmaceutical industry millions of dollars and affect thousands of people every year. By Mark Camercon