Insights On Clinical Technologies
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Leveraging Multiple Data Sources For Comprehensive Insights
5/22/2024
Discover how integrating internal and external data can enhance decision-making and efficiency, how to manage diverse data sources, and the benefits of a single source of truth for your organization.
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How Important Is Biostatistics?
5/28/2024
Uncover how ProPharma's biostatisticians transform raw data into actionable insights, driving advancements in medical research and healthcare delivery.
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What Do Biostatisticians Think Of The ICH E9(R1) Addendum?
7/23/2024
Gain insights from Kristina Bondareva, Head of Biostatistics at OCT Clinical, on the significance of the Addendum and the importance of adopting the estimand framework in clinical trials.
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Eliminating The Guesswork From Critical Decision Making
6/19/2023
By leveraging a unified platform, see how this sponsor was able to overcome the logistical complexities of patient randomization, streamlining, and condensing processes.
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Digital Endpoint Resource Guide: Dermatology
11/20/2023
Dive into recommendations released by the FDA regarding the use of DHTs in clinical development and the opportunities wearable-based digital endpoints present to the life sciences industry.
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EU's New Clinical Trial Regulation: What Does It Hold For Sponsors And Sites?
7/23/2024
The Clinical Trials Information System (CTIS) is a centralized platform for Clinical Trial Application (CTA) and marketing authorization submissions, and supervision of clinical trials across the European Union/European Economic Area (EU/EEA). The regulation, which came into effect on January 31, 2022, aims to simplify and streamline routine clinical processes.
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Technology Overload: Addressing Site Challenges Of Digital Trials
5/23/2024
Watch as speakers explore the experiences of sites conducting digital and hybrid trials, discussing the critical benefits of a change management strategy and a unified digital trial platform.
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Adopting Vault CDMS Accomplishments And Lessons Learned
8/31/2022
GSK leveraged an agile approach and modern ways of working to help shorten their EDC build times. Learn how they reduced EDC build and UAT times by 50% and had all new studies built within Vault CDMS in 18 months.
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Why Adaptive Trial Designs Require Adaptable Technology
4/19/2023
Growing more widespread in clinical research, adaptive trial designs allow for prospectively planned modifications but tend to require versatile technology to support these studies' complex and ever-changing nature.
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The EU (536/2014) CTIS Database Has Been Approved – What Happens Now?
8/10/2022
In January 2022, EU (536/2014) – a binding regulation across all members of the EU – came into effect. The new regulation will streamline procedures and remove duplication of single submission via a single EU portal. It also focuses on an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, a greater level of harmonization, and transparency requirements.