Scrutinizing Non-Core Protocol Procedures

Getz, Kenneth A.
March 2013
Applied Clinical Trials;Mar2013, Vol. 22 Issue 3, p22
Academic Journal
The article informs that pharmaceutical company Medidata Solutions Inc. has sponsored a research study in which several biotechnology companies participated and provided data on 10 Phase II and III protocols targeting diseases throughout multiple therapeutic areas. It informs that the companies classified each protocol procedure during the study according to the objective it supported as defined by the clinical study report (CSR) and the study's specific statistical analysis plan (SAP).


Related Articles

  • Medidata Solutions Worldwide.  // Applied Clinical Trials;Dec2005, Vol. 14 Issue 12, p136 

    The article presents information about a pharmaceutical company, Medidata Solutions Worldwide. Medidata Solutions Worldwide offers electronic clinical data management solutions in data capture and reporting. In more than seventy countries Medidata Solutions works with global pharmaceutical,...

  • CTNeT Selects Medidata Solutions as Strategic IT Partner.  // Biomedical Market Newsletter;4/7/2012, Vol. 21, p1 

    The article focuses on signing contract between Medidata Solutions Inc., clinical development solutions and the Statewide Clinical Trials Network of Texas (CTNeT), clinical oncology research collaboration, to establish and support clinical and operational processes. It mentions some cloud-based...

  • Medidata Solutions Broadens Capabilities of Its Cloud-based Randomization and Trial Supply Management Solution.  // Biomedical Market Newsletter;4/14/2012, Vol. 21, p1 

    The article informs that Medidata Solutions Inc. has released Medidata Balance, a cloud-based randomization and trial supply management (RTSM) application. Balance will provide the popular block randomization methodology in addition to the powerful and flexible dynamic allocation methodology....

  • Medidata Solutions.  // Medical Device Daily;4/12/2012, Vol. 16 Issue 71, p6 

    The article focuses on a major new release of randomization and trial supply management application Medidata Balance announced by Medidata Solutions.

  • Medidata Solutions Worldwide.  // Applied Clinical Trials;Dec2010, Vol. 19 Issue 12, p110 

    The article presents the corporate profile of Medidata Solutions Worldwide, a provider of clinical development solutions to boost clinical trials based in New York City. The advanced solutions of the company address main functions in the clinical development process including trial planning and...

  • Study Conduct.  // CenterWatch Weekly;10/17/2016, Vol. 20 Issue 41, p2 

    The article focuses on introduction of the Site Advisory Group (SAG) by collaboration of the Society for Clinical Research Sites (SCRS) with data analytics provider Medidata for management of clinical trials and views of Medidata's managing director April Mulroney over reimbursement technology.

  • A Clinical Sea Change. Mucke, Hermann A. M.; Goodman, Michael S. // Pharmaceutical Executive;Jun2006Supplement, Vol. 26, p20 

    The article focuses on the attitude of the U.S. pharmaceutical industry towards change, and assesses the viability of their response to the changing clinical environment. Problems encountered in the performance of clinical processes such as securing of contracts and approvals and the development...

  • INDUSTRY SPONSORED TRIALS. Julious, Steven A.; Pyke, Stephen; Hughes, Sara // BMJ: British Medical Journal (Overseas & Retired Doctors Edition;3/19/2011, Vol. 342 Issue 7798, p613 

    A letter to the editor is presented in response to the article "CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials" which appeared in the "British Medical Journal."

  • Paperless Progress.  // Applied Clinical Trials;Oct2005, Vol. 14 Issue 10, p66 

    Focuses on the popularity of eSourcing or capturing clinical data electronically at the source to encourage completely paperless submissions of clinical trial results in the United States. Partnership between Janssen Pharmaceutica NV and Medidata Solutions on the development of Medidata Rave...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics