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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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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.
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Driving Clinical Speed and Agility Post-COVIDImprovements in data management and collaboration forge path to greater efficiency.
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Africa is Biosimulation’s Next FrontierThe answers to meeting biosimulation's growing demand for talent may lie in Africa.
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Unraveling DCT MisconceptionsDCTs can be a great tool for small-to-midsize pharma and biotech companies despite misconceptions of them being advantageous for only Big Pharma.
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Lessons Learned in 2022 and the Impact on Drug Development in the Year AheadDCTs and RWD among topics for industry to focus on moving into 2023.
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What Stands in the Way of an Efficient CRO-Pharma Collaboration?Survey taken by CROs and pharma/biotech companies seeks answers in maximizing partnership.
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Clinical Trials Are Changing—What Does This Mean For IRT?Expectations for trial design will continue to change, and it’s critical that IRT vendors continue to listen to their customers and evolve their offerings accordingly.
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FDA Launches Pilot Program Using Cancer Biomarkers to Mitigate RiskFDA’s new voluntary pilot program is designed to help clinicians select appropriate cancer treatments for patients.
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Rare Disease Patients Overlooked During COVIDSurvey data shows individuals are not informed on how COVID-19 could affect their conditions.
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Vaccines Approved and Under Development Against COVID-19Today's reality and the hopes of tomorrow of the COVID-19 pandemic—an updated mapping of vaccines authorized by regulatory bodies and those close to it.
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Referral Partner Integration: Maximize the Efficiency of Patient ReferralsA win-win-win for sites, sponsors, and referral partners.
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Rare Disease Clinical Trials: Strategies Learned from Duchenne Muscular DystrophyApproaches sponsors, CROs, and investigators can take from the DMD experience.
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Achieving Successful Decentralized Trials by Leveraging RBQM and Centralized Monitoring OversightAs market factors drive the rapid growth of decentralized clinical trials, organizations should embrace risk-based quality management to evaluate the new dimensions of risk and ensure effective oversight of disparate data sources, writes John Hall.
Latest:
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.
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Adapting Site Selection for Clinical Trial Decentralization and the Future LandscapeSites not expected to fade away even as DCTs continue to grow past COVID-19.
