Authors
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On your Mark…Get Set…Go?...or Go!Understanding how your strategy will be re-shaped post-COVID.
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Advancing Human Healthcare Through Accessible Trial Data and AnalyticsThe Clinical Study Data Request consortium is actively pursuing platform interoperability to allow data to be merged and analyzed as an important step for advancing human healthcare.
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Technology’s Role in Managing a Compassionate Use ProgramViiV Healthcare outlines techniques and tips for implementing a technology-based process for handling compassionate use requests.
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The ICR-CRM-IQVIA Research Network Collaboration ExperienceA discussion of the impact of a strategic alliance in to facilitate operational success at the clinical trial site level in Malaysia.
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Is Retraining on Good Clinical Practice Guidelines Effective?Survey results from Clinical Research Malaysia’s GCP refresher workshop.
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Clinical Trials in the Baltic StatesThe region has an appropriate population size, solid infrastructure, experienced nvestigators, and short timelines.
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The Importance of Site SelectionCase study focused on quest for potential Parkinson’s biomarker highlights opportunities and challenges in site selection.
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The Importance of Site SelectionCase study focused on quest for potential Parkinson’s biomarker highlights opportunities and challenges in site selection.
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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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Beyond Hard Outcomes: The Next Era in Heart Failure R&DWhy and how FDA is funding a digital biomarkers study that centers on quality of life for patients with heart failure.
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Virtual Clinical Studies: Finding a Path to ExecutionThe regulatory path for virtual studies is nebulous and potentially difficult to navigate-finding a way forward requires a thorough understanding of the terrain and how to apply existing legal frameworks.
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Updates on Drug and Device Regulatory Reform in ChinaOutlining the nation’s key changes and current requirements in processing investigational and new drug applications.
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Updates on Drug and Device Regulatory Reform in ChinaOutlining the nation’s key changes and current requirements in processing investigational and new drug applications.
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Updates on Drug and Device Regulatory Reform in ChinaOutlining the nation’s key changes and current requirements in processing investigational and new drug applications.
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Updates on Drug and Device Regulatory Reform in ChinaOutlining the nation’s key changes and current requirements in processing investigational and new drug applications.
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Labeling Challenges From EU Annex VIA new era for clinical trials supply compliance in the EU is almost here.
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Assessing Suicide Risk in Clinical Trials: The Patient Knows BestDuring clinical trials of pharmaceutical treatments, sponsors and CROs need to detect possible suicidal ideation and behavior related to their drug during baseline assessments, and throughout treatment as well as during the follow up phases.
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Assessing Suicide Risk in Clinical Trials: The Patient Knows BestDuring clinical trials of pharmaceutical treatments, sponsors and CROs need to detect possible suicidal ideation and behavior related to their drug during baseline assessments, and throughout treatment as well as during the follow up phases.
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Overcoming Barriers in Conducting Decentralized Clinical TrialsNew recommendations offer guidance on overcoming legal, regulatory, and practical hurdles.
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The Missing Puzzle Pieces to Trial RepresentativenessTruly moving the needle in clinical trial diversity comes down to embracing two fundamental pieces of the DE&I puzzle.
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Essential Criteria Biopharmaceutical Investors Seek when Evaluating Compounds and CompaniesThis whitepaper outlines the most important criteria investors look for when evaluating the investment potential of a pipeline compound and the company behind it.
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Rare Patient Advocacy Groups Reach Tipping Point of InfluenceUsing venture philanthropy to get promising drug candidates past “the valley of death”-and supported by advanced scientific technology-rare disease patient organizations have moved beyond being just hopeful influencers, to now becoming powerful forces for change.
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The Future of Clinical Trials: Predictions for 2020Greenphire's Chief Commercial Officer predicts 2020 will continue the momentum towards greater technology adoption and patient focus.
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The Future of Clinical Trials: Turning Data Chaos into Trial IntelligencePoll taken by leading biotech executives in clinical development addresses state of data quality and management.
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Addressing the Immunogenicity ChallengeHow modeling and simulation technology can predict and better manage immunogenicity, a key challenge for biologics drug development.
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Addressing the Immunogenicity ChallengeHow modeling and simulation technology can predict and better manage immunogenicity, a key challenge for biologics drug development.
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Estimand Framework: What it is and Why You Need itWith the final approval and release of ICH E9 (R1), clinical trial sponsors should prepare to include estimands in their protocols as well as their statistical design documents and study reports.
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Estimand Framework: What it is and Why You Need itWith the final approval and release of ICH E9 (R1), clinical trial sponsors should prepare to include estimands in their protocols as well as their statistical design documents and study reports.
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Estimand Framework: What it is and Why You Need itWith the final approval and release of ICH E9 (R1), clinical trial sponsors should prepare to include estimands in their protocols as well as their statistical design documents and study reports.
