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Agile in Life Sciences R&DAgile Product Development Methodology holds great promise for use in Adaptive Clinical Study Development.
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Contract Research Organizations: Leveraging Technology for SuccessThe handling of payments is frequently an aspect of contract research organizations work that goes underappreciated and undervalued, despite its critical importance.
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Common Technical Document DevelopmentPartnership formation is the new trend in common technical document development.
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Privacy and ProvenanceProvenance is at the heart of the discussion when it comes to the equation of privacy and provenance.
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The Changing Landscape of Clinical Research Sites With Frenova Renal ResearchKurt Mussina, MBA, president of Frenova Renal Research, explains how the site landscape is changing for clinical research. He has years of experience leading a global network of investigators, patients and data scientists involved in clinical studies. He brings a unique perspective to what the major problems in clinical research sites are, including private equity and industry consolidation. Refreshingly, he provides solutions Frenova is implementing that will promote better clinical research sites.
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Data Trends That Will Transform Clinical Trials in 2025 - What You Need to KnowWebinar Date/Time: Wed, Jan 22, 2025 11:00 AM EST
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Clinical Trials Don't Have to Cost Too Much or Take Too LongAnalyzing data to reveal site performance patterns for better trial planning and execution.
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Clinical Trials Don't Have to Cost Too Much or Take Too LongAnalyzing data to reveal site performance patterns for better trial planning and execution.
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Clinical Trials Don't Have to Cost Too Much or Take Too LongAnalyzing data to reveal site performance patterns for better trial planning and execution.
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A Digital Twin on CAR-T Cytokine Release Syndrome (CRS) Patients with Standard of Care Measured by CRS Distribution by GradeUsing existing clinical trial data to proactively model patient safety and efficacy outcomes could aid in accelerating development for areas in need of new therapies.
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New EU (536/2014) Clinical Trial Regulation Set to Attract More Studies and InnovationThe way clinical trials are conducted in the European Union will undergo a major change when (EU) No 536/2014 comes into effect in January 2022. But just being compliant with the regulation should not be considered enough – forward-looking organizations are rethinking how technology can play an important part in bringing efficiencies to clinical trials, by reducing failures and driving operational changes beyond compliance.
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EMA’s Demands for Plain-Language Summaries for Clinical Trial Results that can be Understood by Anyone Could Create new Challenges for SponsorsFrom 2019, to comply with requirements for greater transparency around clinical research as part of the EU Clinical Trials Regulation 536/2014, life sciences firms will be expected to prepare plain-language summaries for all Phase I through IV interventional trials, which can be understood by patients, the general public, and experts.
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International Patient Recruitment: The Grass is Not Always Greener AbroadThere are several important factors which should be considered prior to resorting to international patient recruitment.
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Final Guidance on IRB Written Procedures IssuedThe Office for Human Research Protections at the US Department of Health and Human Services and the US Food and Drug Administration issued a final guidance on May 17 on Institutional Review Board written procedures, which are required under both OHRP and FDA regulations.
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Final Guidance on IRB Written Procedures IssuedThe Office for Human Research Protections at the US Department of Health and Human Services and the US Food and Drug Administration issued a final guidance on May 17 on Institutional Review Board written procedures, which are required under both OHRP and FDA regulations.
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Five Steps to Making Your Clinical Trials Patient-CentricCompanies can utilize the following five tools to set themselves up for a successful trial.
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As Clinical Trials Go International, Operations Go DigitalAs international outsourcing continues to drive the parties contributing to clinical trials farther apart, technology will increasingly serve as a means of bringing them closer together.
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When is it Time to Kill Your Drug? Maybe Sooner Than You ThinkPatients stand to lose the most when sponsors hold too tightly to drugs doomed to fail. This wastes precious time that patients don’t have and squanders valuable resources.
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Does PI Certification Make a Difference?Certified principal investigator certification as a predictor of major and critical protocol deviations in clinical trials.
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Does PI Certification Make a Difference?Certified principal investigator certification as a predictor of major and critical protocol deviations in clinical trials.
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AACR, ASCO Bring New Insights to Liquid BiopsyLiquid biopsy, typically non-invasive blood-based tests for circulating tumor DNA and circulating tumor cells, has been long-hyped as a potential game-changer for cancer treatment.
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Are Clinical Trial Data Shared by the EMA Under Policy 0070 Really Public Data?The general assumption that the Policy 0070 data releases were public data releases can be challenged since there is a mechanism to enforce the ToU, and this mechanism will continue to exist after the Agency moves to the Netherlands.
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Direct-to-Patient Trials: Address Your AudienceCBI Conference Producer, Trevor Sosvielle, recently sat down with Matthew Amsden, CEO of ProofPilot to discuss his early work in HIV prevention trials. Amsden shares how these experiences helped shape ProofPilot and its patient-centric clinical trial approach.
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Can Sponsors Answer 6 Questions Regulators Ask During Audits?Switching from paper records to an electronic drug accountability IRT system can benefit sites during FDA trial site audits.
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Patient Value Creation & Pharmaceutical R&D PrioritizationJames Man considers the practical measures firms can take to embed the patient perspective more directly into their R&D planning.
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What ICH E6 (R2) Means for Investigative Sites, Risk Assessment and Clinical Trial MonitoringThe last time the ICH GCP Guideline was updated, the process of conducting a clinical trial, including risk assessment and monitoring, was a largely paper-based affair. Since then clinical trials have evolved substantially as they’ve become more complex, costly, and global in scope.
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What ICH E6 (R2) Means for Investigative Sites, Risk Assessment and Clinical Trial MonitoringThe last time the ICH GCP Guideline was updated, the process of conducting a clinical trial, including risk assessment and monitoring, was a largely paper-based affair. Since then clinical trials have evolved substantially as they’ve become more complex, costly, and global in scope.
