SOURCE: Xtalks

Xtalks Webinars

February 09, 2017 07:30 ET

Integrated Summaries - Tips for Meeting the Challenges Faced by Sponsors, New Webinar Hosted by Xtalks and Presented by CROS NT

TORONTO, ON--(Marketwired - February 09, 2017) - A panel of speakers from CROS NT, including Mark Paul, Senior Vice President, North America, Caroline Terrill, Director of Statistical Programming, and Gail Head, Senior Medical Writer, will focus on helpful tips for Sponsors who are planning Integrated Summaries. Advice will cover Sponsor preparation, regulatory requirements and guidelines, project management challenges and the necessary collaboration between the statisticians, programmers and medical writers. The live event will take place on Tuesday, February 28, 2017 at 11am EST (4pm GMT).

Integrated Summaries of Safety and Efficacy can present challenging timelines, data harmonization challenges and astounding additional costs. How can Sponsors successfully face these challenges?

This webinar is designed to help Sponsors prepare successful and cost-effective projects while collaborating with vendors. At the end of the session, participants should know more about regulatory requirements, understand the steps in preparing a successful Integrated Summaries project and have a better idea of the deliverables they should expect from their CRO.


I. Introduction

  • FDA and EMA requirements and guidelines for Integrated Summaries
  • Challenges Sponsors face in preparing Integrated Summaries

II. Project Management Considerations and Effective Planning

III. Biostatistics and Programming Considerations

  • Statistical Analysis Plan
  • Statistical Methodology
  • Programming Processes and Timelines
  • Implementing CDISC standards

IV. Collaborating with Medical Writing

V. Qualifying a CRO for your Integrated Summaries Project & Conclusion

  • Checklist of what to ask your CRO for an ISS/SIE project

VI. Audience Q&A

To register, please visit: Integrated Summaries - Tips for Meeting the Challenges Faced by Sponsors


Founded in 1992, CROS NT is a data driven Contract Research Organization (CRO) providing services from feasibility to clinical study reporting for Phases I-IV and medical device trials.

CROS NT's services include regulatory, project management, monitoring, data management, biostatistics programming & analysis, pharmacovigilance and medical writing -- and accompanying eClinical applications (data visualization, EDC, IWRS, ePRO etc.). All services are underpinned by strong clinical and biometrics project management.

To learn more about CROS NT visit

About Xtalks

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