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Regulatory Approval in India: An Updated ReviewIssues concerning the drug approval process in India have occurred in clinical studies resulting in a reduced interest from sponsors. The Drug Controller General of India (DCGI) has been working to amend and update it’s policies to stimulate growth in this sector.
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One Way CROs Can Outshine Their CompetitionThe last piece in our three-part series on improving efficiencies and sponsor/CRO collaboration through advanced CTMS, reveals a way in which CROs can best their competition in the marketplace.
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Early Planning Assures Better OutcomesThe early implementation of post authorization safety studies (PASS) will translate to efficiencies in pre-appoval research. These benefits allow for faster approval and wider patient access to potentially life saving therapies.
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Engagement Shift: Informed Consent in the Digital EraWhy electronic informed consent is key to supporting today’s patient-centric mantra in clinical trials.
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The Evolution of Real-World Evidence: Moving Beyond Claims Data in Clinical TrialsIndustry is turning to enhanced data collection methods in response to high demands for efficiency and profitability.
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The Trial of the FutureClinical trials of the future may be closer than we think as we strive to deliver smarter, faster and more cost effective treatment to patients. The data exists to make this possible, now we must change our thought process to meet the needs of patients and sponsors.
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Janssen Autism Knowledge Engine for Clinical TrialsAutism Spectrum Disorder (ASD) is a common neurodevelopmental disorder which does not have an approved medication to address its core symptoms. The Janssen Autism Knowledge Engine (JAKE) was designed to advance the clinical research process for autism by integrating emerging technologies into traditional clinical trial processes.
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Integrated Scanning: A Key to eTMF EfficiencyEven though sponsors and CROs are working to create more and more documents as electronic originals, scanned paper still comprises a large portion of any given eTMF.
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The Growing Availability of Wearable Devices: A Perspective on Current Applications in Clinical TrialsPilot study evaluates the feasibility of using wearable devices in clinical data collection, including the training requirements for appropriate use of the mHealth technologies and the impact of the model on data quality and patient engagement.
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Expected Changes to the Vendor Landscape in 2018An industry shift has led toward more insourcing and in-house resources to run trials.
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Mining Cancer Kryptonite from Historic Clinical Trial DataClinical trial data from completed trials are now beginning to be shared through a variety of channels. While skeptics remain, evidence is growing that this data can lead to practice-changing behavior in patient care.
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Preparing for the ICH E6 (R2) Addendum: A 3-Part SeriesThis 3-part series provides insight into ensuring compliance with the ICH E6 (R2) Addendum to take effect later this year. Part 3 covers the value of embracing a centralized, technology driven approach to risk based monitoring.
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Generic Drug Repurposing Clinical TrialsGeneric drug repurposing can often create medical solutions regardless of the supporting entity. “Unsolved” diseases can benefit from this strategy despite commercialization challenges.
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Closing the LoopPatient recruitment remains a challenge for both the biopharma industry and the oncology research community. New recruiting platforms in development have the potential to change the way the industry uses technology, data and the internet to augment recruiting efforts.
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Multidisciplinary Approach to Protocol WritingThis article examines the requirements for developing an effective Clinical Trial Protocol, observing that it takes time, commitment, and a full team effort to produce protocols of an acceptable standard.
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Remote Monitoring of Patients in Clinical TrialsInvestment in mHealth and the adoption of wearables are significant initiatives that are changing the clinical trial process toward a more patient centered approach. These wearable technology initiatives have the potential to be the most innovative advances in drug development.
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Bring Your Own Device for Trial Outcome AssessmentSurvey uncovers the challenges, myths, and potential useful strategies associated with BYOD adoption.
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Patient Engagement Surveys in Clinical Trials: Dos, Don’ts and How They HelpThis article will address concerns and look at how the pragmatic implementation of surveys in today’s clinical trials can provide valuable insight into patient satisfaction levels, motivators, likelihood to follow study requirements and information retention.
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Taking eCOA Delivery Off the Critical Path to First Patient InStreamlining electronic clinical outcome assessment and patient-reported outcome processes can aid in decreasing timelines.
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Where’s the Exit? An Update on BrexitWith the U.K. poised to begin the process of leaving the European Union soon, many questions remain as to the specifics of pharma regulation and the wide-ranging effects of this departure.
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How Do iComply? Regulatory Topics Surrounding mHealth in Clinical TrialsOutlining several critical areas of regulatory oversight that clinical trial researchers need to consider when using mHealth technologies.
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Digital Transformation of SAE Data Capture in Clinical StudiesProcesses for collecting data of serious adverse events (SAEs) and events of special interest (ESI) during clinical trials have been underwhelming for sponsors. Improving these processes using the latest digital advances can result in more complete analyses and more effective decision-making.
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Future Directions of Cancer Immunotherapy in Clinical TrialsProgress and innovation within oncology has accelerated to a paradigm that includes immunotherapy and bio-genomics. Collaborative approaches in the future will continue to transform treatments in hopes of improving patient quality of life.
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Archiving Approach in the UKThe proper storage of research documents remains an essential aspect of the clinical trials process.
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Partnering with Patients: Clinical Trial Retention and Engagement through Patient Data ReturnHow sharing patient data drives trial engagement and honors patient contributions to the research process.
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The FDA's Guidance on PROThis guidance has both raised the stakes and improved the odds of securing label claims based on PROs.
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Early Phase Pharmacodynamic Models for Respiratory Drug CandidatesRespiratory disease trials are difficult to initiate, both in terms of patient recruitment and accurately collecting data. Alternative methods are required to improve outcomes and develop new treatments for respiratory diseases.
