Authors
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Biomarker BoomA look at the different testing methods and how the results impact drug development.
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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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Adaptive Designs: A Fad or the Future of Clinical Research?Making adaptations to clinical trials in the early stages of research with the use of interim data.
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Critical Appraisal of Clinical Quality Assurance Based on Benchmarking Results: Past - Present - FutureA follow-up survey on clinical quality assurance (CQA) assesses current industry best practices compared to a decade ago, and provides recommendations on this key component of quality management for the future.
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East vs WestHow cultural and training differences affect molecular-based clinical research in China.
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Three Generations of RTSM (Randomization and Trial Supply Management)With all the focus on various data capture solutions in the clinical trials world over the past decade(s), few people seem to have noticed the exponential advances made in the real workhorse systems of the trials: RTSM. Also known as IVR, IWR and IRT, these systems actually execute randomization, blinded supply and resupply management to depots and sites, and most importantly of all, drug dispensing. Is there anything more important to get right?
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Adaptive Designs: A Fad or the Future of Clinical Research?Making adaptations to clinical trials in the early stages of research with the use of interim data.
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Approaching AfricaThe Declaration of Helsinki requires that control groups receive the “best” current treatment, not the “local” one. This shift in wording has profound implications.
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Pharma Casts Out Financial FunctionsOutsourcing finance and accounting can provide cost savings and improve operations.
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Pediatric Research in GermanySurveys among pharma, clinics, and investigators shed light on trials in children.
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Risk Based BudgetingAdoption of the concept of Risk-Based Budgeting could help maintain the trial budget or even save the whole clinical trial.
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Peer Exchange Teaser: eCOA and eConsent within Clinical TrialsGet ready for ACT's upcoming Peer Exchange about the electronic elements of a clinical trial.
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How NLP Surfaces Adverse Events and Safety Insights to Improve Drug Safety ProcessesUse cases show benefits of unlocking data to improve signal and adverse event detection.
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Integrated Multi-Omic Data: Powering Precision MedicineGenomics has long been a primary focus in precision medicine, but other areas of research are increasingly being used to help attain a more complete picture of how an individual’s complex biology impacts their health profile.
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Harnessing the Power of Scientific SurveillanceStatistical methods used via this technique in centralized monitoring.
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Considering Patient Burden in OncologyImplementing new strategies with the use of patient-reported outcomes.
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Virtual Medical Affairs Audits: A Viable AlternativeVirtual audits proving to be beneficial post-COVID despite continuing challenges.
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Facilitating Adoptive Cell Therapy Clinical TrialsEvolving technologies include modification of receptors on T cells to better target tumor microenvironments and minimize off-tumor cross-reactivity.
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Data Collection in Clinical Trials with Multiple CaregiversThe conundrum of missing data vs. inter-rater variability.
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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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Real-World Use of an Artificial Intelligence-Supported Solution for Coding of Adverse Events in Clinical TrialsStudy evaluates the use of AI-supported medical coding module.
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Bringing AI Out of the Shadows and into the Physical World of Drug DevelopmentWhile many groups rely on manual chemistry processes, innovative platforms have emerged that allow these protocols to be executed on custom automation systems.
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Gilead’s Trodelvy Plus Keytruda Significantly Improves Progression-Free Survival in PD-L1-Positive Metastatic Triple-Negative Breast CancerFull results from the Phase III ASCENT-04/KEYNOTE-D19 study demonstrated statistically significant and clinically meaningful survival benefits in patients with previously untreated, PD-L1-positive metastatic triple-negative breast cancer.
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Facilitating Adoptive Cell Therapy Clinical TrialsEvolving technologies include modification of receptors on T cells to better target tumor microenvironments and minimize off-tumor cross-reactivity.
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The Current Status of European Research Related to COVID-19: The EUCROF PerspectiveSuccessful collaborations between Pharma/Biotech/Device industries and CROs will play a key role in an effective fight against the global COVID-19 pandemic.
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Preparing for Pivotal: Solving Challenges in Scale for Cell and Gene Therapy Clinical TrialsTuesday, June 22, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST
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Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE SummitIn this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
