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Latest:
European Pediatric Informed Consent and AF: Current Status of Country RequirementsThe Pediatric Working Group of EUCROF launched an initiative to achieve standardization of generic Informed Consent Form and Assent Form templates within European countries. The differences are noted based on a prior survey.
Latest:
European Pediatric Informed Consent and AF: Current Status of Country RequirementsThe Pediatric Working Group of EUCROF launched an initiative to achieve standardization of generic Informed Consent Form and Assent Form templates within European countries. The differences are noted based on a prior survey.
Latest:
European Pediatric Informed Consent and AF: Current Status of Country RequirementsThe Pediatric Working Group of EUCROF launched an initiative to achieve standardization of generic Informed Consent Form and Assent Form templates within European countries. The differences are noted based on a prior survey.
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Top Three Translation Strategies for Global TrialsGlobalization has increasingly become a part of the clinical trial landscape as pharma sponsors conduct trials internationally. With language barriers being among the challenges of this process, translation management is now a must during the planning phase of a global trial.
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What Are You Wearing?While wearable devices are mainly an advantageous way to collect data from monitoring a trial participant’s progress, there are scientific and operational considerations to be aware of.
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The Growth of Direct-to-Patient TrialsQ&A explores the evolution of community-based studies-and the related sample management, regulatory, compliance, and logistics support considerations.
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Direct-to-Patient Clinical Trials: Strategies for SuccessThe exponential growth in the use of Direct-to-Patient clinical trials and the strategies pharmaceutical manufacturers should consider when implementing this model.
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Assessing Global Clinical Supply LogisticsStudy collects first comprehensive metrics on current supply management and distribution practices.
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Assessing Global Clinical Supply LogisticsStudy collects first comprehensive metrics on current supply management and distribution practices.
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Assessing Global Clinical Supply LogisticsStudy collects first comprehensive metrics on current supply management and distribution practices.
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Ensuring High-Quality Data in Complex, In-Home Clinical TrialsTo support complex in-home clinical research and investigative sites, well-designed trials must produce the same high-quality data as traditional sites.
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Risk-Based Monitoring: What Does it Mean for Clinical Study Sites?Risk-based monitoring continues to remain in the spotlight as an accepted and oft implemented approach that is likely to become an industry standard. However, concerns have mounted about the potential impact of these changes on clinical study sites.
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Interventional vs. Non-interventional Study Classification in the EU: Considerations on the Impact of Direct-to-Patient ContactsA new clinical trial regulation in Europe aims to bring about harmonization of European Union (EU) clinical trial multi-country applications. This paper poses a consensual review, fine-tuning, and validation of study classification while further clarifications on this law are sought out.
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Interventional vs. Non-interventional Study Classification in the EU: Considerations on the Impact of Direct-to-Patient ContactsA new clinical trial regulation in Europe aims to bring about harmonization of European Union (EU) clinical trial multi-country applications. This paper poses a consensual review, fine-tuning, and validation of study classification while further clarifications on this law are sought out.
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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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Centralizing Your Clinical Trials OfficeHospitals and health systems are making significant changes to their research operations in conjunction with the increasing complexities of clinical research. Adopting a centralized clinical trials office (CTO) can greatly assist in managing these changes.
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Risk-Based Quality Management: The Importance of Risk CommunicationAmid the recently released ICH E8 (R1) draft guidelines further supporting RBM strategies, practical methods for integrating critical-to-quality (CTQ) factors within the operational execution life cycle of a clinical trial are presented.
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The Changing Role of the CRO: Impact on Project ManagementAs more strategic partnerships emerge, demands on CROs have intensified-resulting in the need for next-level competencies for project managers.
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Why Pharma Should Be Looking to AerospaceThe pharma and aerospace industries share similarities whereas both are highly regulated, risk adverse and fast-paced markets. However, if there’s one thing that pharma companies can learn from the aerospace industry, it’s their approach to operations.
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Anonymization and Redaction of Clinical Trials According to the EU RegulationOutlining the techniques for anonymization of clinical study reports and the identification and redaction of commercially confidential information to comply with EMA's Policy 0070 on trial data disclosure and transparency.
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Anonymization and Redaction of Clinical Trials According to the EU RegulationOutlining the techniques for anonymization of clinical study reports and the identification and redaction of commercially confidential information to comply with EMA's Policy 0070 on trial data disclosure and transparency.
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Considerations on Layperson Trial Summaries in the EUAnalyzing the debate around writing and constructing layperson summaries of clinical trial results-and proposing a “reader-centered” approach.
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Anonymization and Redaction of Clinical Trials According to the EU RegulationOutlining the techniques for anonymization of clinical study reports and the identification and redaction of commercially confidential information to comply with EMA's Policy 0070 on trial data disclosure and transparency.
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Risk-Based Monitoring Versus Source Data VerificationPilot study compares a risk-based monitoring and remote trial management method with traditional on-site source data verification for trial oversight.
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Risk-Based Monitoring Versus Source Data VerificationPilot study compares a risk-based monitoring and remote trial management method with traditional on-site source data verification for trial oversight.
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Subject Profile Analyzing Risk Saves Time for MonitorsIn a comparison study of source data review (SDV) methods, this new process demonstrates the value of using well-planned data visualization tools to provide better quality oversight versus remote eCRF review or onsite SDV.
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Subject Profile Analyzing Risk Saves Time for MonitorsIn a comparison study of source data review (SDV) methods, this new process demonstrates the value of using well-planned data visualization tools to provide better quality oversight versus remote eCRF review or onsite SDV.
