Authors
Latest:
Risk-Based Monitoring Versus Source Data VerificationPilot study compares a risk-based monitoring and remote trial management method with traditional on-site source data verification for trial oversight.
Latest:
Risk-Based Monitoring Versus Source Data VerificationPilot study compares a risk-based monitoring and remote trial management method with traditional on-site source data verification for trial oversight.
Latest:
Subject Profile Analyzing Risk Saves Time for MonitorsIn a comparison study of source data review (SDV) methods, this new process demonstrates the value of using well-planned data visualization tools to provide better quality oversight versus remote eCRF review or onsite SDV.
Latest:
Subject Profile Analyzing Risk Saves Time for MonitorsIn a comparison study of source data review (SDV) methods, this new process demonstrates the value of using well-planned data visualization tools to provide better quality oversight versus remote eCRF review or onsite SDV.
Latest:
Subject Profile Analyzing Risk Saves Time for MonitorsIn a comparison study of source data review (SDV) methods, this new process demonstrates the value of using well-planned data visualization tools to provide better quality oversight versus remote eCRF review or onsite SDV.
Latest:
Subject Profile Analyzing Risk Saves Time for MonitorsIn a comparison study of source data review (SDV) methods, this new process demonstrates the value of using well-planned data visualization tools to provide better quality oversight versus remote eCRF review or onsite SDV.
Latest:
Subject Profile Analyzing Risk Saves Time for MonitorsIn a comparison study of source data review (SDV) methods, this new process demonstrates the value of using well-planned data visualization tools to provide better quality oversight versus remote eCRF review or onsite SDV.
Latest:
Subject Profile Analyzing Risk Saves Time for MonitorsIn a comparison study of source data review (SDV) methods, this new process demonstrates the value of using well-planned data visualization tools to provide better quality oversight versus remote eCRF review or onsite SDV.
Latest:
Subject Profile Analyzing Risk Saves Time for MonitorsIn a comparison study of source data review (SDV) methods, this new process demonstrates the value of using well-planned data visualization tools to provide better quality oversight versus remote eCRF review or onsite SDV.
Latest:
Medical Photography: Limitless ApplicationsThe range of imaging modalities available for the enhancement of clinical trial endpoint data is as broad as the range of treatment methods available. Whether in the laboratory, clinical or real-world environment, medical photography can be tailored to document working practices and record both subjective and objective efficacy data.
Latest:
FDA Binding Guidance: A Pivotal Milestone for CDISC StandardsFor those still waiting, the time is now to get compliant on FDA's new data submission requirement.
Latest:
Solutions Driving Efficiency in Clinical TrialsThe advancement of technology has allowed for new solutions to become available in all areas of clinical trials. Patient Recruitment Systems are no exception as they can be used to improve the trial process by optimizing protocols, selecting high potential sites and enabling more studies.
Latest:
Solutions Driving Efficiency in Clinical TrialsThe advancement of technology has allowed for new solutions to become available in all areas of clinical trials. Patient Recruitment Systems are no exception as they can be used to improve the trial process by optimizing protocols, selecting high potential sites and enabling more studies.
Latest:
Top 5 Global Clinical Trial Disclosure Changes in 2020 Amidst PandemicSpotlight on clinical trials created by COVID-19 pandemic has forced regulatory officials around the world to expand disclosure requirements on results.
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.
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.
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.
Latest:
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.
Latest:
FDA Inspections Face Continued Overhaul and ChangesAgency will be reorganizing field force and compliance functions.
Latest:
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.
Latest:
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.
Latest:
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.
Latest:
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.
Latest:
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.
Latest:
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.
Latest:
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.
Latest:
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.
