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Finding Patient X: The Role of Digital Media in Rare Disease ResearchDigital media is becoming a crucial vehicle for finding “Patient X” for rare disease drug trials. Three areas in particular where digital media is helping with the detective work are explored.
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Preparing Specialty Lab Data for FDA Submission in the New Regulatory EnvironmentBiomarker and specialty lab data are increasingly being incorporated in FDA submissions given the robust insights they provide on key clinical objectives, including pharmacological effects, and drug safety and effectiveness.
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Preparing Specialty Lab Data for FDA Submission in the New Regulatory EnvironmentBiomarker and specialty lab data are increasingly being incorporated in FDA submissions given the robust insights they provide on key clinical objectives, including pharmacological effects, and drug safety and effectiveness.
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Generative AI Holds the Key to Transforming Trial DesignWhile still in its infancy, generative AI will continue to be integrated into clinical operations.
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This Clinical Trials Day, Honor Employees by Combatting TurnoverJohn Ebeid, Senior VP of Randstad Life Sciences writes that though International Clinical Trials Day is a time to celebrate the medical researchers who work to make new discoveries for the good of public health - retaining these employees remains a challenge for the entire industry, especially for today's CROs.
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BlockChain in Clinical Trials—the Ultimate Data NotaryAssessing the benefits of using blockchain technology as a notary service in the network sharing of clinical data.
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The Use of a Single Center, Multi-Location Research Structure For Participation in Large Clinical Trials: The Cleveland Clinic ModelAs funding for clinical research trials decreases and sponsors of clinical studies are under increasingly stringent timelines to obtain FDA approval and get new therapies to market, the need increases for well-managed, efficient, and effective clinical trial sites.
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Buy a Diploma, Buy a Degree, Go to JailEducation Falsification has more consequences than not having a degree.
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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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Key Considerations for the Adoption of eConsent for SitesThere are many benefits for sites adopting electronic informed consent and it is vital that site study teams are not bystanders in the move towards its use.
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Maximizing Immuno-Oncology Clinical Trial SuccessExamining the unique standards and related challenges when assessing the safety and efficacy of cancer immunotherapy candidates.
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The Transformation of Clinical Trials from Writing on Papyrus to the World of TechnologyNew requirements must be put in place to ensure data quality and integrity.
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Selecting Study-Appropriate Clinical Sites in 3 StepsThese three steps should take place in order to ensure an optimal site selection.
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Special Populations Underrepresented in Oncology Research: Challenges and Solutions to Engage the Hispanic PopulationDespite the evidence that the Hispanic population is increasing at a formidable rate, they not only face disadvantages in health care access, but are significantly underrepresented as participants in biomedical research.
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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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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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Empower Sponsor Success with Insights from SitesAre you tired of clinical trial technology that slows down processes? Are your sites looking for more intuitive solutions? At YPrime, we’ve taken a deep dive into site experiences and perspectives, sharing ways to bridge the gap between sponsors, sites, and patients, to foster a more efficient clinical trial process.
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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.
