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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.
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Are New Medicines Being Developed to Meet the Needs of the Ever-Ageing Population?The elderly population is still underrepresented in clinical trials, with nearly a third of newly registered drugs included an insufficient number of elderly participants, leading to uncertainties regarding safety and effectiveness for prescribers.
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Are New Medicines Being Developed to Meet the Needs of the Ever-Ageing Population?The elderly population is still underrepresented in clinical trials, with nearly a third of newly registered drugs included an insufficient number of elderly participants, leading to uncertainties regarding safety and effectiveness for prescribers.
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Patient Registries and Rare DiseasesResearchers are turning to patient registries to fill rare-disease knowledge gaps.
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Solving the Data Management Challenge in Digital Clinical TrialsRichard Young previously explained on ACT why sponsors need a strong data foundation for successful digital clinical trials. Now he focuses on how to address some of the associated data management challenges.
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Why You Should Expand Your Patient Advocacy Strategy to Include Health InfluencersWith radio, billboard, TV, and digital advertisements being left in the dust, additional engagement from influencer communities are more likely to be reach patients.
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Three Steps to Better DecisionsDecision makers can increase collaboration, transparency, efficiency, and effectiveness, while reducing development risks.
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Train, Analyze, Intervene: How a Three-Pronged Approach Improves Data Quality in Dermatology TrialsThis whitepaper offers readers tips on how to improve the data quality in dermatology trials using a unique, three-pronged approach.
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How to Get Data and Safety Managers on the Same TeamEvery successful clinical trial must protect patients while collecting complete, accurate data that supports evaluation of the safety and effectiveness of the drug or device. Here’s a closer look at why data and safety managers are so important to a clinical trial, what can go wrong when they aren’t aligned and how to improve collaboration between them.
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Fair Market Conundrum: Solutions for Sponsors & SitesBreaking through the confusion around fair market value when applying the concept to study budgets.
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Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources & Best PracticesWebinar Date/Time: Wed, Jan 17, 2024 12:00 PM EST
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Clinical Trials and Social NetworkingThere are significant challenges facing the pharmaceutical and contract research organization (CRO) industries in relation to patient recruitment of clinical trials and the need to implement new strategies to finally overcome what has been called ‘the most difficult and challenging aspect of clinical trials.’
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MENA: The Dawn of a New EraThe Middle East and North Africa region has seen a recent increase in clinical trials research.
