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A Guide to Protecting Data Integrity When Transitioning Rescue StudiesData validation, consistent communication, and meticulous documentation all keys to successfully switching CROs.
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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.
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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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How Unified Insight Into Live Data Helped One Sponsor Succeed Where Many Others Failed***Live: Monday, December 7, 2020 at 2pm EST | 1pm CST | 11am PST***Discover how a North American pharmaceutical company succeeded where dozens of trial sponsors had failed. Leveraging innovative new clinical software, the company helped transition its breakthrough science into trial success, by delivering consistently impeccable data that accelerated the program with far less cost and effort – ultimately leading to a successful submission***On demand available after final airing until Dec. 7, 2021***
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Navigating the Complexities of Patient Screening: Streamlining the Process for Accelerated Clinical TrialsDiscover how streamlining patient screening can help accelerate clinical trials. Simplifying and improving the patient journey and optimized screening processes can help improve clinical trial efficiency and stakeholder experience.
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A Look Back: How Far Clinical Trial Technology Has ComeDigitalization has revolutionized an industry once reliant on paper collection.
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An Adaptive-Block Randomization Method when Stratifying by Investigator in Small-to Medium-Sized StudiesA novel adaptive-block method of randomization to maximize the efficiency of overall treatment group balance, while maintaining balance at investigational centers in smaller sized studies, is proposed.
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Empowering Sites to Optimize Clinical Trial PerformanceSponsors and CROs can ease the burdens of patients, sites, and physicians by identifying these 3 key areas.
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Shortening Clinical Drug Supply Timelines Using AIAI can also help reduce waste from 70% to 25%.
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Data Integration Strategy: The Cornerstone Of A Successful Regulatory SubmissionThe data, not the plan, provide the direction.
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The Bridges We Must BuildImproving clinical trial diversity and health equity through strategic collaborations.
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FDA Patient-Focused Drug Development Guidance Update: Incorporating Patient Experience Data in Clinical TrialsThe four new methodological Patient-Focused Drug Development guidance documents the FDA is currently developing for the industry that incorporate patient experience data into drug development, summarized.
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The Answer to Streamlined Clinical TrialsCloud-based clinical metadata repositories can aid in accelerating clinops.
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Decibel Therapeutics case studyFounded in 2015, Decibel is a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance. For this growth-stage biotech, Egnyte has been a valuable partner in supporting clinical and regulatory operations, medical writing, biostatistics and data management teams with a single repository for all documentation gathered from CROs and submitted to the FDA and other regulatory agencies.
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Overcoming the Pitfalls of Using Real-World Evidence in Regulatory SubmissionsUtilizing a broad network of provider sites is key in overcoming failure and enabling access to high quality data.
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How Digital Will Transform Product Development in 2022 and BeyondPandemic sparks new long-term plan for success in R&D.
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Redefining CRO Sourcing Model Terminology to Optimize Outsourcing StrategiesDifferentiating FSO and FSP approaches can better align definitions of models for CROs and sponsors.
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Enabling Patient Data Ownership With Self-Sovereign IdentityBuy-in from industry stakeholders pivotal to ensure bright future for the decentralized approach.
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Generative AI-Enabled/Augmented Clinical Trials: The Road AheadThe current clinical development model is shifting toward a generative AI-augmented proactive approach supported by real-world data for real time evidence.
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Pandemic Challenges and Opportunities for Gender Equity in Clinical ResearchIndustry must act now to minimize effects of COVID-19 on clinical research.
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Improving Diversity in Clinical Trial Volunteer Participation by Addressing Racial and Ethnic Representation Among the Clinical Research Workforce2020 Tufts CSDD study examines relationship between investigative site personnel diversity and study participant diversity.
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How Cloud Technologies are Enabling the Decentralization of Clinical Trials*** Wednesday, May 19, 2021 at 12pm EDT *** Join partners IQVIA Technologies and Salesforce for this webinar where we explore a new paradigm in life sciences where virtualization of clinical trials, both for patients and sites, has become a reality, and why it has become the industry’s new technological imperative. ***On demand available after final airing until May 19, 2022***
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Establishing a Basis for Secondary Use Standards for Clinical TrialsStudy seeks to understand how different forms of data meet the needs of researchers.
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Sharing Clinical Trial Results with Pediatric ParticipantsSurvey uncovers pediatric-patient perspectives on plain language summaries.
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Revolutionizing Oncology: Insights on the FDA’s Project Optimus and Dose OptimizationFinal guidance suggests sponsors select two doses for Phase II trials with additional data requirements.
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Advancing Safeguards for Innovative Clinical ResearchStakeholders are increasingly turning to data monitoring committees for better oversight.
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Population Representation: Everyone Must Play a PartThe responsibility of increasing diversity falls on every stakeholder in the clinical trial value chain.
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COVID-19 Vaccines: Tool to Predict and Manage Global Portfolio Productivity and RiskPolicymakers should break with drug and biotech norms and apply risk-based portfolio simulations to understand the global portfolio of COVID-19 vaccines.
