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Trends in Global Public and Patient Perceptions of Clinical ResearchTo inform our understanding of public and patient trust and confidence, this article provides a high-level summary of the results of two studies monitoring trends in international public and patient attitudes and perceptions.
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Sharing Stories of Clinical Trial Participation from Start to FinishHow mapping patients’ health journeys can drive a deeper understanding of their experiences and motivations.
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Leveraging Technology to Bridge Clinical Trial Processes and Real-World Health CareBuilding upon the usage of technology in health care delivery, integrating technology into clinical research as a care option will be a game changer in achieving greater participation in clinical research and decreasing the overall time for trial completion.
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Leveraging Technology to Bridge Clinical Trial Processes and Real-World Health CareBuilding upon the usage of technology in health care delivery, integrating technology into clinical research as a care option will be a game changer in achieving greater participation in clinical research and decreasing the overall time for trial completion.
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Applying Learning Health Systems to Advance Clinical Research and Health CareThe use of Learning Health Systems in order to advance clinical research.
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FDA Issues Final Rule on Data Acceptance from Clinical Investigations for Medical DevicesThe FDA published a final rule on FDA’s standards for accepting data from clinical investigations for medical devices on February 21.
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FDA Issues Final Rule on Data Acceptance from Clinical Investigations for Medical DevicesThe FDA published a final rule on FDA’s standards for accepting data from clinical investigations for medical devices on February 21.
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Master Protocols in Oncology: A Review of the LandscapeWith technology’s increasing ability to gather and analyze previously unmanageable data sets, and medicine’s forays into genomics and targeted therapies, the time of the master protocol may be at hand.
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Master Protocols in Oncology: A Review of the LandscapeWith technology’s increasing ability to gather and analyze previously unmanageable data sets, and medicine’s forays into genomics and targeted therapies, the time of the master protocol may be at hand.
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Master Protocols in Oncology: A Review of the LandscapeWith technology’s increasing ability to gather and analyze previously unmanageable data sets, and medicine’s forays into genomics and targeted therapies, the time of the master protocol may be at hand.
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Master Protocols in Oncology: A Review of the LandscapeWith technology’s increasing ability to gather and analyze previously unmanageable data sets, and medicine’s forays into genomics and targeted therapies, the time of the master protocol may be at hand.
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Finding Patient X: The Role of Digital Media in Rare Disease ResearchDigital media is becoming a crucial vehicle for finding “Patient X” for rare disease drug trials. Three areas in particular where digital media is helping with the detective work are explored.
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Preparing Specialty Lab Data for FDA Submission in the New Regulatory EnvironmentBiomarker and specialty lab data are increasingly being incorporated in FDA submissions given the robust insights they provide on key clinical objectives, including pharmacological effects, and drug safety and effectiveness.
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Preparing Specialty Lab Data for FDA Submission in the New Regulatory EnvironmentBiomarker and specialty lab data are increasingly being incorporated in FDA submissions given the robust insights they provide on key clinical objectives, including pharmacological effects, and drug safety and effectiveness.
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Generative AI Holds the Key to Transforming Trial DesignWhile still in its infancy, generative AI will continue to be integrated into clinical operations.
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This Clinical Trials Day, Honor Employees by Combatting TurnoverJohn Ebeid, Senior VP of Randstad Life Sciences writes that though International Clinical Trials Day is a time to celebrate the medical researchers who work to make new discoveries for the good of public health - retaining these employees remains a challenge for the entire industry, especially for today's CROs.
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BlockChain in Clinical Trials—the Ultimate Data NotaryAssessing the benefits of using blockchain technology as a notary service in the network sharing of clinical data.
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The Use of a Single Center, Multi-Location Research Structure For Participation in Large Clinical Trials: The Cleveland Clinic ModelAs funding for clinical research trials decreases and sponsors of clinical studies are under increasingly stringent timelines to obtain FDA approval and get new therapies to market, the need increases for well-managed, efficient, and effective clinical trial sites.
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Buy a Diploma, Buy a Degree, Go to JailEducation Falsification has more consequences than not having a degree.
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EMA’s Demands for Plain-Language Summaries for Clinical Trial Results that can be Understood by Anyone Could Create new Challenges for SponsorsFrom 2019, to comply with requirements for greater transparency around clinical research as part of the EU Clinical Trials Regulation 536/2014, life sciences firms will be expected to prepare plain-language summaries for all Phase I through IV interventional trials, which can be understood by patients, the general public, and experts.
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Key Considerations for the Adoption of eConsent for SitesThere are many benefits for sites adopting electronic informed consent and it is vital that site study teams are not bystanders in the move towards its use.
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Maximizing Immuno-Oncology Clinical Trial SuccessExamining the unique standards and related challenges when assessing the safety and efficacy of cancer immunotherapy candidates.
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The Transformation of Clinical Trials from Writing on Papyrus to the World of TechnologyNew requirements must be put in place to ensure data quality and integrity.
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Selecting Study-Appropriate Clinical Sites in 3 StepsThese three steps should take place in order to ensure an optimal site selection.
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Special Populations Underrepresented in Oncology Research: Challenges and Solutions to Engage the Hispanic PopulationDespite the evidence that the Hispanic population is increasing at a formidable rate, they not only face disadvantages in health care access, but are significantly underrepresented as participants in biomedical research.
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Agile in Life Sciences R&DAgile Product Development Methodology holds great promise for use in Adaptive Clinical Study Development.
