Featured Articles
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Navigating Key Complexities In The Development Of Cell & Gene Therapies
5/17/2023
By engaging with the right partner, discover how biotech companies can navigate the full research and development continuum.
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Key Efficiencies Driven By A CTMS
5/16/2023
Is your clinical trial management system being used to the fullest? Discover the benefits of centralized data management, real-time tracking, automated workflows, and comprehensive reporting.
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Improving Diversity In Clinical Trials: Strategies For Inclusive & Ethical Research
5/16/2023
Explore the importance of diversity in research and the challenges surrounding recruitment and retention of underrepresented populations.
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eReg Benefits For Clinical Research: Use Cases For All Types Of Sites
5/1/2023
Unearth the different kinds of eRegulatory use cases for diverse clinical site types and other eRegulatory capabilities designed to serve all sites.
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FDA Guidance Offers New Flexibility To Biotechs In Cell And Gene Therapy
5/1/2023
Explore the implications of the Food and Drug Administration’s recently released guidance regarding cellular and gene therapy products, including new approaches for studies which could significantly impact early-phase clinical trials.
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Top Three Reasons Why Your Medical Device Needs A Clinical Trial
5/1/2023
Gain insight into why clinical trials are necessary for medical devices, such as ensuring regulatory requirements are met, safety and effectiveness are demonstrated, and data to support reimbursement and market adoption is collected.
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How Single IRB Review Mandates Help Research Sponsors
5/1/2023
Explore the benefits of the Food and Drug Administration’s proposed single institutional review board (sIRB) mandates for multisite clinical studies.
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Risk Assessment For Use Of Engineered Genetic Materials In Clinical Research
4/28/2023
Discover the benefits of a thorough IBC risk assessment, including compliance with regulations and standards, enhanced safety measures, and improved communication among research team members.
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Patient Recruitment From A Site Perspective
4/28/2023
When used strategically and in conjunction with traditional enrollment methods, see how technology can significantly enhance patient recruitment efforts.
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Setting Yourself Up For Success During Investigator-Initiated Trials
4/28/2023
An IIT is a result of an investigator creating an idea for a study, developing the protocol, and serving as both the sponsor and the investigator for the trial. Discover why there is much to plan in order for it to run smoothly.