CLINICAL TRIAL COMPLIANCE & OPERATIONS TECHNOLOGY INSIGHTS
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FDA's Elsa May Prompt Pharma To Rethink Regulatory Filings
AI expert Pradeepta Mishra of Beghou Consulting explains why pharmaceutical companies need to quickly evolve their regulatory strategies, authoring procedures, and governance frameworks in light of the FDA's new Elsa generative AI pilot.
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Integrating QMS And eTMF For Proactive Clinical Trial Quality
In today’s clinical trial landscape, where complexity is the new challenge, integration is not optional: QMS defines quality, and eTMF proves it.
IRT RESOURCES
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Learn how applying predictive data analytics can enable the creation of an ideal supply strategy capable of reducing the need for extra shipments, manual oversight, and supply waste.
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Explore how Interactive Response Technologies (IRTs) built around microservices models can provide faster initial builds, more rapid change management, and improved built-in test automation.
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Sites are frequently overwhelmed with the sheer number of technologies they must work with to conduct a clinical trial, and this aggregation platform can streamline trial management.
RBQM RESOURCES
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Clinical data trends are evolving rapidly to reduce trial complexity, improve patient experiences, and shorten development timelines.
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Explore how digital health technologies offer a data-driven solution to cytokine release syndrome (CRS) monitoring, reducing inpatient care requirements while ensuring patient safety.
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Consider these steps when repositioning your clinical data management team to unify cross-functional reviews and align processes and technology to meet the demands of digital trials.
RTSM RESOURCES
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Examine a COVID-19 treatment trial that utilized integrated EDC, eConsent, eCOA, RTSM, and TeleVisit solutions, all within a single platform, to address three critical challenges.
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Learn about the strategy and successful execution of a complex randomization design that helped LG Chem overcome its clinical trial challenges alongside eClinical randomization experts.
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Uncover how this global specialty pharmaceutical company was able to ensure the confidentiality of its blinded study data while receiving flexible and scalable unblinded support.
EREG RESOURCES
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Centralized eSource systems enable complex clinical trials to align with key regulatory frameworks, including ICH E6(R3), ICH E8(R1), and 21 CFR 312, to meet the highest standards of GCP.
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Explore the critical process of Study Start-Up (SSU) in clinical trials, with an emphasis on the collaborative efforts of sponsors and research sites to enhance efficiency and reduce timelines.
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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.
PAYMENT RESOURCES
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Unearth how bringing the functions of medical writing, clinical data management, and electronic data capture can positively impact the creation of a budget and payment process.
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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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Learn about the evolving U.S. clinical trial site market landscape including a detailed analysis of ownership models, market segmentation, and the role of financial investors in acquisitions.
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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In today’s ever-evolving clinical trial space, managing the expenses associated with conducting a study is more important – and fraught – than ever before.
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Learn about how this participant-friendly technology ensures efficient and secure payments, enhancing the clinical trial experience for all involved.