Authors
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New Approach to System ValidationConsiderations in implementing a risk-based framework for computer systems validation.
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Aligning Data Entry and Site Payment Incentives For Clinical Trials and PatientsWith recent reports indicating that organizations do not have a way of tracking and managing the timeliness of data entry or of site payments, The Metrics Champion Consortium wanted to see if there were opportunities to align incentives in the industry so that both sites and sponsors can achieve their goals with positive impact on clinical trials and patients.
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M&A in the Pharma IndustryOrganizations are seeking growth and competitive advantage through mergers and acquistions.
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IDMP: An International Standard for Lifecycle Data ManagementThe implementation of the International Organization for Standardization identification of medicinal products (IDMP) is a key step to ensuring that information on new innovations are identified and captured accurately within the regulatory framework and beyond.
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Collaboration On EU’s New Clinical Trials Rule Brings Opportunity, ChallengesApplication review will require closer cooperation between ethics committees and competent authorities in several areas.
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Academic Research Under the Clinical Trial Regulation – Partial Relief?This article describes the experiences of the Medical University of Vienna with the Directive 2001/20/EC (CTD) regarding academic clinical research and reflects on the changes introduced by the Regulation (EU) 536/2014 (CTR).
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The Regulatory Debate Around Pre-approval Product AccessOutlining current regulatory issues and views surrounding expanded access to investigational products in the U.S.
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Why Real-World Studies Need a Lighter TouchWhy taking a right-sized approach to real-world studies will help keep sites and patients around for the duration.
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Why Real-World Studies Need a Lighter TouchWhy taking a right-sized approach to real-world studies will help keep sites and patients around for the duration.
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Study Insights: Patient Engagement in Drug DevelopmentInitial findings from a DIA study of patient-centric initiatives in drug development reveal pharma’s desire to move toward true patient-centricity, but approaches to implementation are varied.
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Mobile Research Nursing - Bringing the Trial to the PatientThe ability to carry out clinical trial visits in a patient’s home, workplace or location of choice is still an uncommon concept. However, mobile trained research nurses can expand on this idea by conducting ‘off-site’ study visits.
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New Clinical Trials Law in France: Advantages for Medical Device StudiesThe new law on research in France introduces changes for the medical device industry by facilitating the conduct of postmarketing studies. Devices will no longer have to be provided free of charge for low-risk interventional studies making France a possible location for such trials in the future.
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Mobile Research Nursing - Bringing the Trial to the PatientThe ability to carry out clinical trial visits in a patient’s home, workplace or location of choice is still an uncommon concept. However, mobile trained research nurses can expand on this idea by conducting ‘off-site’ study visits.
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Creating Medicines ‘Appropriate for All’Bristol-Myers Squibb’s cardiovascular development leader discusses the importance of diversifying clinical trials for better patient outcomes.
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Point of View: Traceability and Transparency Should be Mandatory for All Human BiospecimensTransparency regarding the source of biospecimens would improve research quality, reproducibility, and translational use of acquired knowledge. Scientific robust publications, dissemination and communication are central to this-as are the regulatory reporting guidelines in play.
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Point of View: Traceability and Transparency Should be Mandatory for All Human BiospecimensTransparency regarding the source of biospecimens would improve research quality, reproducibility, and translational use of acquired knowledge. Scientific robust publications, dissemination and communication are central to this-as are the regulatory reporting guidelines in play.
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Point of View: Traceability and Transparency Should be Mandatory for All Human BiospecimensTransparency regarding the source of biospecimens would improve research quality, reproducibility, and translational use of acquired knowledge. Scientific robust publications, dissemination and communication are central to this-as are the regulatory reporting guidelines in play.
Latest:
Point of View: Traceability and Transparency Should be Mandatory for All Human BiospecimensTransparency regarding the source of biospecimens would improve research quality, reproducibility, and translational use of acquired knowledge. Scientific robust publications, dissemination and communication are central to this-as are the regulatory reporting guidelines in play.
Latest:
Point of View: Traceability and Transparency Should be Mandatory for All Human BiospecimensTransparency regarding the source of biospecimens would improve research quality, reproducibility, and translational use of acquired knowledge. Scientific robust publications, dissemination and communication are central to this-as are the regulatory reporting guidelines in play.
Latest:
Point of View: Traceability and Transparency Should be Mandatory for All Human BiospecimensTransparency regarding the source of biospecimens would improve research quality, reproducibility, and translational use of acquired knowledge. Scientific robust publications, dissemination and communication are central to this-as are the regulatory reporting guidelines in play.
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A Successful Study: The Principal Investigator’s PerspectiveDr. George Atiee shares his perspectives, from that of the principal investigator, on how stakeholders can execute a successful study.
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Mitigating Supply Chain Risk in Clinical TrialsOutlining a decision-making framework that integrates real-world signals with supply planning techniques to reduce risk and avoid potential interruptions.
