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Ways to Streamline Informed Consent Process in Clinical Trial Startup

Optimizing the informed consent process is critical for accelerating clinical trial startup while maintaining compliance and participant understanding. This article explores key strategies for streamlining informed consent, including leveraging electronic consent (eConsent) solutions, standardizing templates, and improving collaboration between sponsors, sites, and IRBs. By implementing these best practices, research teams can enhance efficiency, reduce delays, and improve the participant experience in clinical trials.

Reporting to the IRB: Investigator Noncompliance

We often get questions about exactly what events should be reported to the IRB. We…

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SAE Reporting and the IRB: Adverse Events in Drug Studies

Assessing and reporting adverse events (AEs) in clinical trials is critical to ensuring the study…

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Checklist to Reduce Burden on Sites and Patients

Every site is different. Learn how to meet their unique needs and make workflows and…

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Enhancing User Experience, Security, and Compliance with Single Sign-on

Every day, clinical research organizations work to deliver a seamless user experience for their staff,…

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IRB Review of Changes to Previously Approved Research

During the course of study conduct, most research involving human participants will require some form…

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Clinical Trial Efficiency: Top Risk Indicators and Solutions for Site Performance

Sponsor and contract research organization (CRO) team members such as clinical research associates (CRAs), study…

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Optimizing Site Initiation Timelines Through Centralized Processes

A centralized CTMS team streamlines trial initiation by uniting resources, ensuring data accuracy, and reducing…

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mRNA Cancer Vaccines and Therapies: An Overview

The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps…

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Implementing eSource: A Guide for Operations and Technology Roles

Implementing eSource can streamline data collection for research sites, but ensuring data integrity, compliance, and…

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How Sponsors and Sites Work Together to Improve Protocol Compliance

Sites and sponsors can adopt strategies to reduce quality issues and avoid FDA warning letters…

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Addressing Industry Challenges: Staff Turnover

Staff turnover in clinical research impacts trial quality and timelines. Addressing this requires focus on…

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Our OnCore CTMS Vision: Building a Foundation for Success

OnCore’s future vision focuses on cloud-hosted solutions, cross-platform reporting, and SSO, enhancing efficiency and user…

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