CLINICAL TRIAL COMPLIANCE & OPERATIONS TECHNOLOGY INSIGHTS
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Is Double Programming Really Required For Validation?
Double programming has been the gold standard for validation, but technological advancements and improved sponsor oversight of CRO deliverables have introduced more efficient and reliable alternatives.
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Why Is Trust Stifling Our RBM Implementations?
It’s one thing to implement RBM (risk-based monitoring) components like central monitoring or initial risk assessments, but if you’re still doing 100% SDR/SDV, you’re not maximizing the benefits of this approach. So what’s the holdup?
IRT RESOURCES
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DSG was selected as the preferred vendor for providing global support and enhanced data quality. Find out how the company was able to dramatically improve database build and study conduct.
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Sites juggle dozens of applications, which increases their workload and limits their capacity. Sites need an industry-wide single sign-on experience that brings key systems and applications under one roof.
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This one-minute video highlights the benefits of One Home for Sites. Join the movement to increase clinical trial capacity, because patients are waiting.
RBQM RESOURCES
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Get several pointers on how to facilitate a transition to an agile, multi-faceted, and continuous risk and issue management approach aligned with the Statistical Analysis Plan.
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The industry anticipates a transformative shift towards embedding RBQM as a foundational practice in modern clinical research as a means to enhance trial efficiency and safety.
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This article takes a more in-depth look at Sections 5.0.5: ‘Risk Communication’ and 5.0.6: ‘Risk Review.’ in ICH-GCP E6 R2 to show how the implementation of RBQM can reduce issues and achieve holistic trial oversight in today’s complex decentralized trials.
RTSM RESOURCES
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With so many moving parts in a clinical trial, why worry about the technology that is supposed to help manage it? In this webinar, explore five actionable and necessary strategies to leverage RTSM to simplify clinical trial operations.
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As clinical trials grow in complexity, discover how adopting adaptive, unified RTSM technology can help to reduce costs and maintain accurate, real-time study data.
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The pharmaceutical industry is full of acronyms. Gain insight into the evolution of the acronyms, the technology and the terminology, specifically for RTSM (Randomization and Trial Supply Management).
EREG RESOURCES
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Electronic clinician-reported outcomes (eClinROs) enhance the quality and consistency of clinical trial data. Discover key factors to consider when selecting an eClinRO provider.
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By following this checklist, research teams can enhance organizational efficiency, maintain compliance with regulatory standards, and confidently navigate the complexities of documentation management.
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By addressing the unique hurdles tied to regulations in European clinical trials, eBinders offer a streamlined approach to managing electronic trial documentation.
PAYMENT RESOURCES
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Advanced technology and best practices have the potential to revolutionize clinical trial site payment forecasting, leading to significant improvements in overall trial efficiency and management.
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Discover how Greenphire's innovative payment solutions can transform your clinical trial operations and ensure site sustainability.
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Discover how a specialized site payment solution can streamline your clinical trials, enhance site engagement, and deliver measurable financial benefits.
IRT SOLUTIONS
RBQM SOLUTIONS
RTSM SOLUTIONS
EREG SOLUTIONS
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Hassan Khalid of AstraZeneca and Jessica Jolly, a senior data and science executive, talk about the advantages of automation as a result of a Guidance like ICH M11, and why “automation” is not synonymous with AI in this case.
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Jessica Jolly, a senior data and science executive, is challenging CDOs (chief data officers) and CDAOs (chief data & analytics officers) to stop putting the data science community “to sleep” with the traditional monotonous SOPs, and instead, move more toward autonomous governance by design.
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Take advantage of this checklist for evaluating eRegulatory solutions for clinical trial offices.
PAYMENT SOLUTIONS
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Enhance your Clinical Trial Payments solution with IQVIA Forecasting to leverage our global expertise and navigate the complexities of payments with ease.
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Integrate data from all industry sources to confidently plan budgets for studies worldwide, across all phases and therapeutic areas.
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In today’s ever-evolving clinical trial space, managing the expenses associated with conducting a study is more important – and fraught – than ever before.