Authors
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Redefining CRO Sourcing Model Terminology to Optimize Outsourcing StrategiesDifferentiating FSO and FSP approaches can better align definitions of models for CROs and sponsors.
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Enabling Patient Data Ownership With Self-Sovereign IdentityBuy-in from industry stakeholders pivotal to ensure bright future for the decentralized approach.
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Generative AI-Enabled/Augmented Clinical Trials: The Road AheadThe current clinical development model is shifting toward a generative AI-augmented proactive approach supported by real-world data for real time evidence.
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Pandemic Challenges and Opportunities for Gender Equity in Clinical ResearchIndustry must act now to minimize effects of COVID-19 on clinical research.
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Improving Diversity in Clinical Trial Volunteer Participation by Addressing Racial and Ethnic Representation Among the Clinical Research Workforce2020 Tufts CSDD study examines relationship between investigative site personnel diversity and study participant diversity.
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How Cloud Technologies are Enabling the Decentralization of Clinical Trials*** Wednesday, May 19, 2021 at 12pm EDT *** Join partners IQVIA Technologies and Salesforce for this webinar where we explore a new paradigm in life sciences where virtualization of clinical trials, both for patients and sites, has become a reality, and why it has become the industry’s new technological imperative. ***On demand available after final airing until May 19, 2022***
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Establishing a Basis for Secondary Use Standards for Clinical TrialsStudy seeks to understand how different forms of data meet the needs of researchers.
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Sharing Clinical Trial Results with Pediatric ParticipantsSurvey uncovers pediatric-patient perspectives on plain language summaries.
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Revolutionizing Oncology: Insights on the FDA’s Project Optimus and Dose OptimizationFinal guidance suggests sponsors select two doses for Phase II trials with additional data requirements.
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Advancing Safeguards for Innovative Clinical ResearchStakeholders are increasingly turning to data monitoring committees for better oversight.
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Population Representation: Everyone Must Play a PartThe responsibility of increasing diversity falls on every stakeholder in the clinical trial value chain.
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COVID-19 Vaccines: Tool to Predict and Manage Global Portfolio Productivity and RiskPolicymakers should break with drug and biotech norms and apply risk-based portfolio simulations to understand the global portfolio of COVID-19 vaccines.
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The ICR-CRM-IQVIA Research Network Collaboration ExperienceA discussion of the impact of a strategic alliance in to facilitate operational success at the clinical trial site level in Malaysia.
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European Commission Adopts Proposal to Delay MDR DeadlinesPandemic and supply shortage among factors in slow transition to new rules.
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Effective regulatory strategies for rare diseaseIn the rare disease issue of New Medicines, Novel Insights from Parexel, experts and former regulators share insights for developing effective regulatory strategies earlier.
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The Future of SDTM Transformation: AI and HITLUsing an AI + Human in the Loop (HITL) approach can be utilized for Study Data Tabulation Model (SDTM) transformation, potentially alleviating current challenges
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The RACE for Children Act Takes Effect This MonthAn amendment to Pediatric Research Equity Act, as part of the 2017 FDA Reauthorization Act, goes into effect soon aiming to change the landscape and promote pediatric cancer drug development.
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Unleashing Their Potential: The Evolving Landscape of DHTsKey considerations in deploying fit-for-purpose digital health technologies in drug development.
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Reprioritizing DNA Damage Response: Leveraging Lessons Learned to Develop Next-Generation InhibitorsAdvancements in this field have the potential to transform cancer care and improve quality of life for patients.
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When Should the Audit Trail Begin?A discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.
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Industry Technology Providers’ Crystal Ball: Trends to Inspire a More Connected 2022What the industry’s most inspiring technology innovators see coming in 2022.
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Breathing New Life into Respiratory Clinical Trials with Digital BiomarkersIncreased data output from the use of devices can accelerate trials for this therapeutic area in need of new therapies.
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Establishing a Basis for Secondary Use Standards for Clinical TrialsStudy seeks to understand how different forms of data meet the needs of researchers.
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Addressing the Cost Barrier to Inclusive Clinical TrialsIn an era of rising healthcare expenses, reassurance about costs for patients in diverse communities is particularly important.
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Digital Biomarkers Solution shows pathway to reduced clinical trial sample sizes, shorter durationsDigital biomarkers provide a pathway to the future where clinical trial sponsors can potentially benefit from reduced trial duration and sample size. Learn more about these benefits from a simulated study.
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Use of Televisits in Studies and Related PV ConcernsWhile televisits can address many medical concerns, one frequent reservation expressed by healthcare professionals is that patients during these televisits tend to present too narrow a picture of their clinical condition-resulting in non-comprehensive medical assessments.
