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Latest:
Endpoint Adjudication of Events Charter Template: What Should Be Included?Endpoint adjudication is gaining importance in pharma today, however, no guidance on endpoint adjudication currently exists. The LinkedIn Endpoint Adjudication Community has generated an Events Charter Template to shed light on the subject for those in need of guidance.
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Endpoint Adjudication of Events Charter Template: What Should Be Included?Endpoint adjudication is gaining importance in pharma today, however, no guidance on endpoint adjudication currently exists. The LinkedIn Endpoint Adjudication Community has generated an Events Charter Template to shed light on the subject for those in need of guidance.
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An Auditor’s View of Compliance ChallengesA look at the unique compliance and patient safety hurdles-and subsequent interventions-for resource-limited trial sites with no prior experience.
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FDA Inspections Face Continued Overhaul and ChangesAgency will be reorganizing field force and compliance functions.
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Biotech Execs Pledge “Reasonable” Price IncreasesMore than 200 biopharma leaders acknowledge that out-of-pocket costs for individuals must be limited to sustain support for fiscal and patent policies key to advancing innovation.
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Achieving CRO OversightAs business grows with the addition of more CROs, questions have arisen from sponsors about how to conduct effective CRO oversight. A survey of clinical leaders provides insights to help address key challenges and regulations more quickly and effectively.
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Are You Ready for Phase II?This article provides the necessary steps to advance past Phase II clinical trials on the way toward delivering an impactful drug to market.
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Patient Driven Study DesignA patient-centered study design can improve the trial experience by engaging directly with patients. QuintilesIMS recently completed a case study that supported this concept and showed value toward patient recruitment.
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Site Calls for IRT SimplicityRoger DeRaad of Black Hills Cardiovascular Research and his staff discuss their experiences using IRT systems with 4G Clinical’s Kathleen Greenough. They offer insights into how sites, sponsors and technology vendors can cooperate to bring simplicity to clinical trials.
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The Convergence of Cancer Research and Clinical TrialsNew technologies have accelerated the speed and effectiveness of clinical research and trials. This convergence is making it possible for new innovations and possibilities to bring groundbreaking treatment options to patients.
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Balancing Privacy and Access to Health Information in the Age of Big DataThe Expert Determination standard of protecting patient privacy can answer the growing demand for better data for research and analytics in healthcare.
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What Are You Wearing?While wearable devices are mainly an advantageous way to collect data from monitoring a trial participant’s progress, there are scientific and operational considerations to be aware of.
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No-Brainer Provisions of the 21st Century Cures ActThe 21st Century Cures Act, passed in December, contains provisions that many have questioned and criticized. This review of those provisions shows that progress in this sector is being made.
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Malaysia’s Clinical Research EcosystemExamining the role of Clinical Research Malaysia in advancing industry-sponsored drug development in the country.
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Malaysia’s Clinical Research EcosystemExamining the role of Clinical Research Malaysia in advancing industry-sponsored drug development in the country.
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Cancer Moonshot 2020: Next Generation Standard of Care for CancerThe war on cancer has seen significant strides made in the search for a cure, however, recent data suggests that the work is far from over.
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MythBusting: 6 eConsent Myths we Need to Correct in 2018Debunking the six most common myths regarding electronic informed consent.
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A Practical Overview of Patient-Centric TrialsA how-to guide for clinical trial managers in implementing patient-centric approaches using today’s clinical study model.
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A Practical Overview of Patient-Centric TrialsA how-to guide for clinical trial managers in implementing patient-centric approaches using today’s clinical study model.
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We Need a Next-Generation RBM Approach TodayThe pharma industry needs an improved risk-based management approach to better handle the increased complexity of trials, to improve the quality of studies and to better adhere to new guidelines from regulatory agencies.
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Investigator Engagement: The Key to Solving the Clinical Trial Enrollment CrisisSponsors have been addressing the problem with initiatives designed to find, attract, and retain patients in clinical trials more effectively.
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How to Simplify Site Tasks and Help Ensure Dispensing AccuracyClinical technologies have the ability to streamline the daily processes of site staff and insure a more efficient clinical trial.
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How to Simplify Site Tasks and Help Ensure Dispensing AccuracyClinical technologies have the ability to streamline the daily processes of site staff and insure a more efficient clinical trial.
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Rapid Study Startup: Streamlining Trial Site ActivationThe redundancy of process and documentation for activating trial sites has been an issue in the past as it can lead to delays in trial initiation. Rapid study startup can illuminate these inefficiencies by removing or reducing non-value tasks.
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An Economic Evaluation of Clinical HomecareExamining the cost and patient recruitment and retention benefits of bringing clinical research procedures to the subject’s home.
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An Economic Evaluation of Clinical HomecareExamining the cost and patient recruitment and retention benefits of bringing clinical research procedures to the subject’s home.
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TMF Reference Model Opens 2017 SurveyThe TMF Reference Model has released a survey for industry professionals designed to provide insight for both paper and electronic trial document management.
