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Boston, MA – November 1st, 2022  – SDC is proud to announce SDC Insights™, the first of multiple new technology solutions that will provide clients with better access to their data during and after clinical trials. The data visualization tools, which help clients quickly see visual breakdowns of their projects, launched last month.

Here are a few key components of the new products:

Data Warehousing Services: Allows clients to securely store data and leverage other SDC offerings with the company’s data warehouse. Additionally, clients can access their data directly and build their own cross study reports, such as cross study site reporting, that our underlying data model will accelerate development time while streamlining the submission process.

Data Visualization Tools:

• Clients with complex reporting needs can leverage SDC’s data visualization to access universal dashboards from different data sources all in one place.
• The platform creates a single integrated source for data review, allowing clients to monitor risks and address performance trends across all platforms in a centralized location.
• Clients have the capability to upload data from other sources being utilized.

“In our 16th year as a biometrics-based CRO, SDC is excited to be expanding its global footprint working across all sizes of pharmaceutical, biotech and medical device studies,” says [Faith Kolb, Chief Operating Officer]. “SDC’s data visualization tool creates a single source of truth across studies, saving time and optimizing next steps. The launch of this technology offering will soon be followed by other industry leading advancements developed by our dedicated team and will continue to ensure we are assisting our clients in treating patients around the world.”

Contact us today to schedule an overview on how SDC Insights™ will help you streamline your clinical trials.

About SDC:
Statistics & Data Corporation (SDC) is a specialized data service and strategic scientific contract research organization (CRO) that has been providing solutions for pharmaceutical, biotech, and medical device/diagnostic research trials since 2005.

SDC delivers top-tier clinical trial services and technologies to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. We are committed to providing experienced teams who will take ownership of your needs and are positively engaged in your projects. With strategic consulting, biometric services (biostatistics, data management) and technology solutions (EDC, IRT/RTSM, eSource, data analytics/warehousing) expertise at our core, our services are scalable to provide seamless full service clinical trial solutions. SDC Insights trademark pending.

Dale Usner to Present at Duke-Industry Statistics Symposium

ICH E9 (R1) at DISS 2020

Dale W. Usner, PhD, Chief Scientific Officer & Sr. Vice President, Strategic Scientific Consulting at SDC, will present “Considerations and Impact of Various Hypothetical Strategies for Handling Intercurrent Events” at the Duke-Industry Statistics Symposium on Thursday, April 2, 2020. He is scheduled to present in the session on ICH E9 (R1)-Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.

Read more in our online news release.

Tempe, AZ, January 23, 2020 – Dale W. Usner, PhD, Chief Scientific Officer & Sr. Vice President, Strategic Scientific Consulting at SDC, will present “Considerations and Impact of Various Hypothetical Strategies for Handling Intercurrent Events” at the Duke-Industry Statistics Symposium (DISS) on Thursday, April 2, 2020.

Hosted by the Department of Biostatistics and Bioinformatics at Duke University School of Medicine, the annual symposium promotes research and collaboration among statisticians from industry, academia and regulatory agencies. Concluding with a job fair on Friday afternoon, the three-day event will focus on “Emerging Clinical Initiatives in Pharmaceutical Development: Methodology and Regulatory Perspectives.”

Usner’s presentation will be held during the Thursday afternoon session on ICH E9 (R1)-Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials. Co-organized by Roann Seay, Senior Biostatistician at SDC, this session features five presenters to explain the ICH E9 (R1) addendum and provide important guidance for understanding and implementing estimands in clinical trials.

“Estimands and intercurrent events have been an interest of mine since the ICH E9 (R1) draft was first released a couple years ago,” said Usner. “I am particularly interested in the impact of differential handling of intercurrent events on the outcomes of primary and sensitivity/robustness analyses. I look forward to discussing these in detail at the symposium.”

“On behalf of the organizing committee, we are very grateful for Dale to share his expertise in the area of estimands and sensitivity analyses at the symposium,” said Seay. “With statistical leaders from CROs, sponsors, regulatory bodies and academia addressing key topics like ICH E9 (R1), data monitoring committees, adaptive trial designs and artificial intelligence, DISS is shaping up to be a must-attend event this year.”

For more information or to register for DISS 2020, please visit https://sites.duke.edu/diss.

Update 5-Mar-2020: The Duke-Industry Statistics Symposium has been rescheduled. This event will take place on August 26-28, 2020.

 

Tempe, AZ, January 14, 2020 – SDC is excited to announce that Kalyani Kothapalli, MS, Director, Biostatistics at SDC, will present a poster at the ARVO Annual Meeting in Baltimore, MD, on May 3-7, 2020.

Kothapalli is first author on the abstract entitled “Simulations to estimate power in correlated binary data,” which was accepted on January 8, 2020 by the ARVO Annual Meeting Program Committee. Dale W. Usner, PhD (Chief Scientific Officer & Sr. Vice President, Strategic Scientific Consulting at SDC) and Erin H. Leone, PhD (Biostatistician at Applied Genetic Technology Corporation [AGTC]) are co-authors on the poster.

“We are excited to present outcomes from our research into design-based power maximization accounting for both eyes in ophthalmic rare diseases,” said Usner.

The date and time of this poster presentation have yet to be announced. To view posters presented by SDC at previous ARVO conferences, please see Publications and Posters.

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