Webinar

High Performance Data Science to Accelerate Clinical Research

The landscape of pharmaceutical data science is evolving, marked by the complexity of numerous data sources and an increased demand for high-quality data early in the drug development process. The advent of new AI and adaptive trial tools underscores the importance of accessing quality data at the outset of clinical trials. Consequently, there’s a pressing need for tools that effectively manage the diverse components of this process, including tracking data sources, analyzing programs, and managing outputs.

A modern SCE (Scientific Computing Environment) solution is crucial to address these challenges. Such a solution should offer:

  • The ability to integrate and refine data from various sources, making it readily accessible for use. MaxisIT’s Data Management platform excels in connecting with multiple data sources, providing capabilities for cleaning, aggregating, transforming, and harmonizing data.
  • A versatile platform for statistical programming with access to multiple programming languages. MaxisIT’s SCE provides flexibility by supporting various programing languages and via BYOIDE (bring your own integrated development environment), while enabling early reviews using R/Shiny apps.
  • The capacity to coordinate and oversee the multiple facets of data science projects. MaxisIT SCE enhances team collaboration, offering comprehensive audit trails and tracking for data, programs, and outputs. It provides metadata-driven automation along with auditability via “Knowledge graphs”, which makes SCE modern and future ready.

Key Takeaways:

  • Data Science Complexity: Grasping the importance of high-quality early data in drug development.
  • Quality Data’s Role: Understanding its critical use in clinical trials with AI and adaptive tools.
  • Data Management Tools: Identifying essential tools for effective pharmaceutical data science.
  • Modern SCE Benefits: Learning how MaxisIT’s SCE solution streamlines data integration and project management.

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Speakers

Jerald S. Schindler, DrPH

Principal, Strategic-Statistics, LLC

Jerald Schindler has over 30 years of experience in senior executive leadership roles developing drugs, biologics and devices for regulatory approval. During this time, he has been the global leader of Biostatistics, Programming, Data Management, and Clinical IT. He has led the teams involved in over 40 successful FDA advisory committee meetings and many successful regulatory submissions in the US and across the world.

Dr. Schindler was one of the early advocates of adaptive clinical trials and is still involved in developing novel ways to collect and analyze high quality data quickly and efficiently. He has led the design and development of innovative IT platforms to acquire, manage, analyze and report data which has greatly accelerated the approval of new drugs. He currently consults with various pharmaceutical companies on FDA interactions, protocol design and analysis, advisory committee preparations and IT technology. Previously, he was the Global Head of Late Development Statistics at Merck Research Laboratories, The Chief Biostatistician and Global Head of Biostatistics and Clinical Technology at Wyeth Research, and the Global Head of Enterprise Biostatistics at Medtronic.

Sarika Karnik

Clinical Solutions Owner, MaxisIT

Sarika Karnik brings over 20 years of industry expertise, with a decade-long dedication to leveraging technology for empowering clients and propelling their success, particularly within the clinical data industry. As a seasoned professional, she adeptly combines strategic expertise with innovative solutions, reshaping industries and championing client achievements through forward-thinking technological advancements. Sarika has notably contributed her talents and vision to MaxisIT, driving transformative initiatives and fostering groundbreaking approaches within the realm of clinical data technology.

Jerald S. Schindler, DrPH

Principal, Strategic-Statistics, LLC

Jerald Schindler has over 30 years of experience in senior executive leadership roles developing drugs, biologics and devices for regulatory approval. During this time, he has been the global leader of Biostatistics, Programming, Data Management, and Clinical IT. He has led the teams involved in over 40 successful FDA advisory committee meetings and many successful regulatory submissions in the US and across the world.

Dr. Schindler was one of the early advocates of adaptive clinical trials and is still involved in developing novel ways to collect and analyze high quality data quickly and efficiently. He has led the design and development of innovative IT platforms to acquire, manage, analyze and report data which has greatly accelerated the approval of new drugs. He currently consults with various pharmaceutical companies on FDA interactions, protocol design and analysis, advisory committee preparations and IT technology. Previously, he was the Global Head of Late Development Statistics at Merck Research Laboratories, The Chief Biostatistician and Global Head of Biostatistics and Clinical Technology at Wyeth Research, and the Global Head of Enterprise Biostatistics at Medtronic.

Sarika Karnik

Clinical Solutions Owner, MaxisIT

Sarika Karnik brings over 20 years of industry expertise, with a decade-long dedication to leveraging technology for empowering clients and propelling their success, particularly within the clinical data industry. As a seasoned professional, she adeptly combines strategic expertise with innovative solutions, reshaping industries and championing client achievements through forward-thinking technological advancements. Sarika has notably contributed her talents and vision to MaxisIT, driving transformative initiatives and fostering groundbreaking approaches within the realm of clinical data technology.

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