Two Draft White Papers on Standard Analyses open for review

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Silver Spring (MD), February 2014


Two draft white papers were developed by the CSS working group whcih creates white papers providing recommended display and analysis including Table, Listing and Figure shells are open for review.

The first draft White Paper about PK describe analyses and displays Associated to Non-Compartmental Pharmacokinetics – with a focus on clinical trials.

The second draft White Paper about Analyses and Displays Associated with Outliers or Shifts from Normal to Abnormal with a Focus on Vital Sign, Electrocardiogram, and Laboratory Analyte Measurements in Phase 2-4 Clinical Trials and Integrated Submission Documents is available for review by 28 February 2014.

Check [[1]] for more details.

About the CSS

The Annual Computational Science Symposium (CSS) brings together Academia, Regulators, Industry and technology providers to address computational science needs in support of regulatory review and ultimately bring safe and effective products to those who need them.

The focus of the CSS is to continue the work initiated at the previous annual meetings by bringing FDA, industry and academia together to provide an update on current initiatives ongoing within the FDA, explore emerging technologies and establish collaborative working groups to address current challenges related to the access and review of data to support product development. Previous work has included the creation of a Study Data Reviewer's Guide Template for submission, development of a non-clinical road map and the application of semantics technology to standards.

For more details on the CSS see here

Phuse css2014 banner.jpg

About PhUSE

PhUSE, Share – Contribute – Advance, provides the industry with the premier platform for creating and sharing ideas, tools and standards around data, statistical and reporting technologies; PhUSE is a non-profit, volunteer-supported, community of professionals who are passionate about advancement of clinical information. Since its inception, PhUSE has expanded from its roots as a conference for European Statistical Programmers, to a global platform for the discussion of topics encompassing the work of Data Managers, Biostatisticians, Statistical Programmers and eClinical IT professionals.