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Fast Track Implementation of eConsent: COVID-19 Paves the Way for Virtual TrialsAs many countries slowly progress with the “New Normal,” researchers and healthcare providers are assessing digital/virtual approaches that could reinstate clinical trials.
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Prioritizing People: Why ‘I-Frame’ Interventions are Key to Trial SuccessBy embracing this leadership approach, clinical research stakeholders can prioritize more effective staff training and readiness.
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Gender Bias in the Clinical Evaluation of DrugsPast decades have shown gender-based differences in clinical trial results are often overlooked when considering safety and effectiveness.
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Accelerating Clinical Trials in the EUThe ACT EU initiative aims to develop the European Union further as a competitive center for innovative clinical research.
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Innovating Beyond the Lab: The Critical Role of Contracting in ResearchBiotechs can successfully overcome bottlenecks in time-to-market for new drugs by embracing contracting innovations with the same passion applied to research breakthroughs.
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The Problem with Decentralized Clinical Trials and How to Solve for SuccessWed, Sep 7, 2022 11:00am EST | 8:00am PST | 4pm BST | 5:00pm CEST Decentralized Clinical Trials (DCT) is one of the hottest buzzwords in Life Sciences and Connected Health organizations today. Like any new approach, challenges and roadblocks are common and knowing how to solve for them will empower your organization to accelerate your trial deployment, speeding return of results and time to market.
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Pitfalls to Avoid with Clinical AdjudicationInvolvement of clinical endpoint committees in the adjudication process can improve reliability and robustness of data.
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Characterizing Clinical Data Management Challenges and Their Impact2020 Tufts CSDD – IBM Watson Health benchmarking study highlights need for new functionality from EDC solutions and providers.
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Optimizing Drug Development for Solid Tumors: Leveraging Innovative Trial Designs and Advanced Imaging TechniquesHow innovative trial designs and advanced imaging modalities can address the challenges of early drug development to optimize outcomes for patients with solid tumors.
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‘Upskilling’ Your Workforce to Keep Pace with ChangeThe DCT-driven evolution requires new levels of understanding and expertise.
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Considering Patient Burden in OncologyImplementing new strategies with the use of patient-reported outcomes.
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An Examination of the Role of the Clinical Research Associate and Factors Impacting Performance and ExperienceStudy by Tufts CSDD uncovers potential reasons behind CRA shortages, turnover, experience requirements, and more.
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Four Key Trends for Identifying Regulator and Payer Evidence Needs in Oncology Drug DevelopmentHow to leverage novel trial designs and real-world data to support a cancer drug submission with an evidence strategy that is both approvable and reimbursable.
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Clinical Study Audits: The Quality Management ApproachAdvancing risk-based auditing one step further by identifying the underlying process deficiencies to enable improved corrective and preventive actions.
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Sharing Anonymized and Functionally Effective (SAFE) Data Standard for Safely Sharing Rich Clinical Trial DataPresenting how data transformation is measured as part of the SAFE Data Standard, which data variables influence the rating and, how the appropriate level of data transformation is calculated.
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DMCs: Maintaining Data Integrity in COVID-19 ClimateRegulators are urging the use of data monitoring committees to support clinical trial management and decision-making during pandemic.
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Q&A With Daniel Lofaso, CEO of Digital ElevatorIn this Q&A with Applied Clinical Trials' sister brand, Pharmaceutical Executive, Lofaso discusses marketing strategies for early-stage biotech companies, including how they can effectively recruit patients for their clinical trials.
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At-home Self-collection of Blood Specimens for Safety Lab Testing in Clinical Trials via the Tasso+ DeviceLaboratory services organization focuses on easing patient and site burden with improved collection device.
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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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Blending Models for Better Sourcing SolutionsCRO-sponsor relationships are key as industry moves towards new age of outsourcing.
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Optimal COA Measurement Strategy in Modern Oncology TrialsExamining the two areas of weakness cited in FDA draft guidance.
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Introducing PALADINFirst-of-its-kind consortium dedicated to accelerating new medicines development through optimizing patient advocacy group—industry collaboration.
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Managing Clinical Trial AgreementsHow Clinical Research Malaysia sped up CTA turnaround using a web-based system.
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Getting to Clinical Trial DiversityDiffering levels of trust in clinical trials information channels across diverse populations is examined in this research.
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Creating Future-Ready Teams for Digital Clinical TrialsThe need for specific capabilities to suit DCT business models is creating new challenges in team building, training, and development.
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Where Innovation and Patients Meet to Improve Cancer CarePromising scientific advances are pacing oncology drug development.
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Revamping Site Feasibility as Trials Become DecentralizedHow asking better questions and leveraging site databases can expand access to more patients.
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How to Operationalize Infectious Disease Trials with a Virtual SiteIn this playbook, learn how a virtual site solution expands access to infectious disease clinical trials by allowing patients to enroll and participate from anywhere.
