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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.

Patient-centric Clinical Trials: Evolving Strategies for Engagement and Retention

  In the ever-evolving world of clinical research, patient engagement has become a critical focus…

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Modernizing Site Feasibility and Selection

Study startup is a complicated, multi-faceted process – notoriously prone to delays due to the…

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Unpacking IRB Innovations for Decentralized Clinical Trials

In the blink of an eye, the world has gone digital. So many tasks which…

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How Paper and Electronic Source Data Meet ALCOA-C Principles

According to the FDA, data should meet certain fundamental elements of quality (ALCOA), whether they’re…

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Strategies for Successful Site Selection in Clinical Trials

Clinical trial site selection can make or break a trial’s success before it even begins.…

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Keys to Unblocking the Innovation Bottleneck in Research

Is the clinical research industry winning or failing at innovation? It probably depends on who…

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Decorative image representing an Informed Consent Form with items highlighted

Informed Consent Writing Tip Sheet

Crafting informed consent forms requires balancing regulatory compliance with participant understanding, ensuring consent is both…

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How the IND 30-day Hold Impacts Clinical Trial Activities

The Food and Drug Administration (FDA) is the federal entity in the U.S. charged with…

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Streamline Study Startup with Improved Site Selection & Feasibility

Streamline Study Startup with Improved Site Selection & Feasibility

Site selection for clinical trials is often one of the biggest headaches for pharmaceutical sponsors…

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Scale Your Training Program: Three Successful Models

Scale Your Training Program: 3 Successful Models

From live sessions to eLearning, scalable training models ensure clinical research teams stay effective, well-informed,…

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21 cfr part 11 compliant software image with a lock

Beginner’s Guide to 21 CFR Part 11 Compliance

Ensuring 21 CFR Part 11 compliance in research software protects data integrity, security, and audit…

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Regulatory, Clinical, and Quality Considerations for Device Research

Regulatory, Clinical, and Quality Considerations for Device Research

In response to a growing demand for faster, approved, and cost-effective medical devices for chronic…

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