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Experis

Statistical Programming

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A Trusted Partner for Your Statistical Programming Efforts

Clinical Solutions provides high-quality, cost-effective Statistical Programming support to some of the world’s largest Life Sciences companies through a variety of models including Functional Service Provider (FSP), study-specific or rescue study support, as well as various resourcing solutions across the clinical trial spectrum. Our Clinical Development Centers in the U.S. and Eastern Europe are home to some of the top clinical talent in the industry. Our study team leads and engagement managers have decades of industry experience in leading programming teams of all sizes. We offer a variety of services meant to augment and complement your internal teams efforts, including:

  • Analysis Dataset Creation
  • Tables/Listings/Graphs Programming
  • Validation/QC/Verification Programming
  • PK/PD Support
  • Post-Marketing Clinical Data Analysis
  • CDISC/Data Mapping
  • eSubmission Support

You’ll benefit from:

  • Over 30 years of statistical programming experience
  • Experis’ established Clinical Development Centers in the U.S. and Eastern Europe
  • Our refined and established programming processes that can be customized to meet your SOPs or our SOPs
  • A fast program launch due to our extensive network of qualified clinical professionals
  • Our proven Engagement Management process that ensures the appropriate level of communication, quality and timeliness

Start-to-finish statistical programming support

Analysis Dataset Creation

Experis programmers are efficient in the creation of value added datasets, either in a company proprietary standard, or an industry standard, such as ADaM. Our programmers understand the nuances of clinical data and how to implement complex statistical algorithms. Our Lead Programmers and/or Statisticians can also draft detailed specifications for use by the programming team.

Tables/Listings/Graphs Programming

Output displays are the backbone of any regulatory submission. Let our experienced team help create all the in-text and post-text TLGs needed for your clinical study report, annual report or ISS/ISE.

Validation/QC/Verification Programming

Increasing importance is being placed on the accuracy of the work performed by statistical programmers. Our team is well versed in all approaches to validation/verification, from total independent programming (2nd programmer QC) to a more risk-based approach.

PK/PD Support

Experis has highly-specialized and experienced professionals in place who can be up and running much quicker than a nonexperienced PK/PD programmer. This strong internal network allows them to share knowledge and problem solve quickly so that your analysts and clinicians are presented with solutions rather than questions. Our programmers are experienced in both NONMEM and NCA data set creation, as well as TLG outputs.

Post-Marketing Clinical Data Analysis

Our team has a wealth of experience analyzing data from Phase IV clinical trials, as well as publication support. We understand the ad hoc nature of this type of work, and our collaborative, flexible approach is well-suited to this environment.

CDISC/Data Mapping

Our experienced team has been working within the different CDISC models for several years, both SDTM and ADaM. Our Team Leads keep up with all of the changes in the implementation guides produced by CDISC.org, and they develop an understanding of each client’s approach to CDISC compliance. In addition, we have mapped legacy data for hundreds of clinical studies to either the SDTM standard or a different proprietary standard.

eSubmission Support

We understand regulatory filings and where statistical programming fits into the process. We also know that a well-designed electronic portion of a submission can help to facilitate a timely review of the submission by the regulatory agency. Let our experience in this area help get your compound from submission to market more efficiently.

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Medical Device Clinical Trials: What We Should Know

The medical device industry comprises a major sector of the overall healthcare industry, representing a more than $100 billion industry in the U.S. in 2008, roughly 42 percent of the world’s total. While device companies are relatively small compared to pharmaceutical companies, research in this area is growing on its own and is increasingly essential in pharmaceutical research, as well. In this paper, differences between the medical device industry and the pharmaceutical industry will be outlined, and ways of handling clinical trials and the corresponding statistical analysis of medical device data will be discussed.

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