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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.
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Central Monitoring is Uncovering Emerging Quality Risks in Clinical TrialsThe long-held practice is effective in pinpointing the emergence of known and unknown risks to clinical development, study shows.
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We Must Do More to Ensure Women Achieve Their Professional GoalsWith poor retention of women in the biomedical workforce amid the pandemic, industry leaders in clinical research must step up to provide solutions.
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The Regulatory Requirements and Key Points of Drug Clinical Trials Registration in ChinaFollowing the implement of new Drug Registration Regulation in July 2020, the clinical trial registration system will have some major changes in China.
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Are You a Victim of Clinical Trial Fraud? If So, What Are Your Rights and Obligations?Aggressive focus by DOJ has put increased burden on stakeholders to understand their obligations and exposure.
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Clinical Trial Technology: New Kids on the Block are Changing Industry DynamicCOVID has accelerated to the scene upstart digital efforts to transform patient engagement and data management/integration—but progress remains measured.
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Establishing Metrics and Standardization for Non-CRF Data in EDCWhile Case Report Forms are a main contributor to collected data, non-CRF data such as core laboratory data and central imaging can be critical to any clinical study.
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How Sponsors Can Use Health Decision Science to Improve Clinical Trial Recruitment and RetentionExamining the behaviors of clinical trial stakeholders to better understand challenges in patient participation.
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Empowering Sites and Patients: The Impact of Personalized Support in Clinical TrialsTo meet the growing demands of clinical research, sponsors must prioritize comprehensive support models, such as clinical site ambassadors and patient journey coordinators, who can address operational challenges and improve site relationships, patient satisfaction, and overall trial efficiency.
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Self-collection of Blood Specimens in Clinical TrialsOperational and patient burden considerations for self-collection of blood specimens in clinical trials
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Oncolytic Virus Immunotherapy: A Brief Overview and Considerations for Clinical Trial PlanningSuccessful oncolytic virus immunotherapy clinical development requires unique features that focus on viral biology and host immune response.
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Outsourcing Model Usage and its Relationship to Clinical Trial PerformancePilot study seeks to validate new and more granular outsourcing model classifications in differentiating performance across custom contract-service approaches.
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The Future of Personalized Medicine Hinges on Revolutionizing Business ModelsThe era of big pharma as product-first companies must end, as services become the larger priority.
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Trials During the Pandemic: A CRO's PerspectiveFindings from an OCT Clinical survey of researchers from 61 sites in Russia to gain the perspective of an investigator regarding clinical trials during the COVID-19 pandemic.
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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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ROI of ePRO Use in Clinical TrialsThe cost and benefits for patients and sponsors in using ePRO versus paper
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How Remote Patient Monitoring Technology Can Impact Decentralized Clinical TrialsWhat is next for DCTs after acceleration from COVID-19?
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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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The Time Is Now: Taxation Reform for Expanded Clinical Trial AccessExpanding clinical trial access to include historically underrepresented ethnic and racial minorities means addressing root-cause barriers, including taxation.
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Insight into the New ICH E6(R3) Draft Guidance on Clinical TrialsDecentralized clinical trials have the potential to expand the number of people who can benefit from clinical trials while accelerating therapies to more patients in need.
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Is There Progress Amidst the Swinging Diversity Pendulum?Recent research from the Tufts CSDD gauged progress in the context of the “Chief Diversity Officer” role at top pharmaceutical companies.
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Filling the Void for Clinical Research Leadership Amidst Political HeadwindsIn this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), highlights how research communities have self-organized in light of recent changes.
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Connection to Communities is Key to Boosting Clinical Trial EngagementTony Clapsis, SVP and General Manager, CVS Clinical Trial Services, reflects on industry’s progress.
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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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Our Top 5 Social Media Posts of the Year 2024Check out our top five most engaged social media posts from the year 2024.
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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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5 Ways DCTs Can Positively Impact Trial DiversityCOVID-19 forces life sciences industry to make long overdue changes.
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Understanding the Complexities of Diversifying Clinical TrialsTufts Center for the Study of Drug Development and Biogen recently conducted a study to inform growing interest in improving diversity of clinical trial participation. The results of this research provide insights into increasing the community of minority investigators and study staff and presenting greater access to clinical trials among minority study volunteers.
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Employing the Power of Bayesian Methods to Expedite LearningBayesian methods bring flexibility and speed to clinical trial design and analysis, and with increased access to the necessary computational power, are transforming today’s clinical research.
