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Study Site Management

    Business InsightsStudy Site Management

    Clinical Trial Binders: Are You Doing it the Hard Way?

    by Imogen Cheese April 9, 2024
    written by Imogen Cheese

    Clinical trials have become more and more complex over the last decade, largely due to the challenges driven by an increasingly global reach. As a sponsor, are you making it hard for clinical trial teams? Learn about a unique solution to managing clinical trial binders.

    A Challenging Part of Study Startup – Clinical Trial Binders

    Since 2016, the highest number of clinical research registrations on clinicaltrials.gov include clinical studies with sites in the Western Pacific, Europe, and Latin America. This spread of global clinical trial activation continues as recruitment efforts increase in lower-income regions and those with unmet medical needs. Clearly, the complexity phenomenon isn’t going away. It’s a challenge that study teams face, especially as they undertake the critical steps of study startup.

    Investigator Site File (ISF) and Pharmacy binders are a requirement for all clinical trials in the study startup process, and clinical trial sites are faced with meeting each country and region’s regulatory requirements regarding what to include. These binders contain key study information, including:

    • Protocol requirements
    • Inclusion and exclusion criteria
    • Regulatory requirements that impact the clinical trial

    Binder Burden

    Step one is the creation of a master set of clinical trial documents. From there, documents for study startup are adapted to each site, country, and region based on regulatory and governmental needs. Thirty percent of studies are U.S. only, and 54 percent are based outside of the U.S. With 66 percent of studies recruiting globally outside of the U.S., these documents must be revised frequently. The burden this places on study teams can be enormous.

    And it’s often a race. Finalizing the study materials and adapting them to include site-specific documentation is often very last minute, with only a week or two available to make final ICF and Pharmacy clinical trial binder files ready to include within the binders. This burden typically falls on local site teams and clinical trial managers to finalize and generate these documents at a site level.

    Research sites’ startup fees may not be enough to cover their time, and clinical trial managers may not bill correctly for the steps, time, and work involved. This is not cost or time-effective. It creates animosity between site teams, wider project support teams, and sponsors, and most importantly, it doesn’t provide the full accounting and audit of each step involved in the study startup. We found that local teams spend an average of 6-7 hours customizing clinical trial binders per study country. This has been the norm for a very long time.

    Clinical Trial Binders: An Imperial Solution

    One of our clients approached us to discuss these challenges and see if we could find a solution to enable a smooth provision of study startup materials for global site locations. This was a challenge, of course. The development, printing, and shipping of the materials would need to be:

    • Centrally managed
    • On demand
    • Flexible
    • Adaptable
    • Immediate

    Our business development, operations, project management, prepress, and production teams worked together. Using our proprietary digital platform, we created a unique solution for site-specific clinical trial binder development and printing. This exciting process does several things:

    • Provides sponsors, CROs, and their study teams with greater control of their binder projects, supported by our dedicated project management team.
    • Removes the need for multiple localized solutions that require contracts, vetting, auditing, and managing.
    • Allows CROs to focus local country resources on other important elements of study startup, as well as monetize previously unbilled time for the development of the customized binders.
    • Gives our clients all over the globe the quick, flexible, dynamic solution that they need.
    • Improves the satisfaction of clinical trial sites.

    In addition, our clients benefit from free warehousing, a 24/7 portal for file uploads, digital proofs, inventory management, and shipment tracking. That’s just a few of the many reasons our clients have adopted and implemented this solution.

    The Imperial Advantage

    The burden on project teams and local site teams increases exponentially with the growing global footprint of clinical trials. It’s part of Imperial’s core goals to do the right thing for our clients. By creating this solution to meet the needs of our clients and, in turn, reducing costs and time, we hope we are exceeding their expectations. And exceeding expectations is one of our corporate goals.

    We are in the solutions business. Let us know your pain points, and Imperial will work with you on a solution.

    _________
    Sources:
    World Health Organization data on trials by year, country, region, and income group
    ClinicalTrials.gov information: trends, charts, and maps

     

    April 9, 2024 0 comment
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  • Patient EngagementStudy Site Management

    Initiatives to Aid the Clinical Trials Industry: A Talk With Norman Goldfarb

    by Dan McDonald March 13, 2024
    by Dan McDonald March 13, 2024

    I recently caught up with my longtime friend and colleague, Norman Goldfarb. Norm is well-known to all of us in the clinical trials industry as an innovator and a best-practice thought leader for fostering clinical trial site relationships with sponsors and CROs. Norm’s resume is…

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  • Ancillary Trial Supplies and EquipmentPatient EngagementPatient Recruitment and RetentionSite Materials & LogisticsStudy Site Management

    6 Top Picks: Clinical Trial Blogs Not to Miss

    by William McEwen December 27, 2023
    by William McEwen December 27, 2023

    The Imperial blog team took a look at our 2023 clinical trial blogs, and we’re shining the spotlight on our top six picks. So here they are, in no particular order: six clinical trial blogs worth reading (and re-reading). 1. Supply Chain: Master these key…

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  • Business InsightsPatient EngagementStudy Site Management

    Asking Why Bolsters Clinical Trial Communication and Success

    by Hope Cullen October 24, 2023
    by Hope Cullen October 24, 2023

    Explore the importance of providing context for decisions in clinical trials to foster improved communication, trust, and success. “Why” seems to be at the center of what we do. Kids are always asking, “Why, Mom?” Lean Fundamentals teaches us the 5 Whys, and Simon Sinek…

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  • Business InsightsStudy Site Management

    Attitude Is a Force – Make It a Positive One

    by Brandon Bissell June 12, 2023
    by Brandon Bissell June 12, 2023

    As part of my leadership blog series, I’d like to describe how a positive attitude in leadership, applied strategically, can be an energetic core of success. First, let’s consider these two words: NEGATIVITY: NOUN The expression of criticism or pessimism. COMPLAINING: VERB The expression of…

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  • Business InsightsStudy Site Management

    Is “Being Intentional” the Force Your Company is Missing?

    by Brandon Bissell March 27, 2023
    by Brandon Bissell March 27, 2023

    For this entry in my leadership blog series, I’d like to talk about intentional leadership and begin by asking: Do you ever feel like you’re on autopilot? You’re not even having to think about what you’re doing – you’re just doing it! Driving, filling out…

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  • Patient EngagementPatient Recruitment and RetentionStudy Site Management

    Clinical Trial Enrollment Timelines: Hidden Causes Behind Big Delays

    by Dan McDonald December 22, 2022
    by Dan McDonald December 22, 2022

    This is the second in my three-part series revealing hidden causes behind delays in clinical studies. The first part is here. This installment explores strategies to meet clinical trial enrollment goals. Tell me when your first patient was enrolled, and I will tell you the…

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  • Patient Recruitment and RetentionStudy Site Management

    Cultivating Site Partnerships for Maximum Recruitment Success

    by Diana Foster October 13, 2015
    by Diana Foster October 13, 2015

    There is a lot of emphasis today on the relationship between sites, sponsors, and their CRO partners. Site sustainability and strong partnerships that help cultivate the success of clinical research sites are of critical importance to the conduct of trials. With enrollment success at the…

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  • Business InsightsStudy Site Management

    End of Study Tasks – Going Beyond the Checklist

    by Ted Corrigan January 20, 2015
    by Ted Corrigan January 20, 2015

    How exciting, it’s finally time to close the Study! Not so exciting – the task list and documentation required to get things in order. Many of our customers have CRA’s or other personnel who are responsible for ‘End of Study’ (EOS) tasks when closing out…

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  • Patient Recruitment and RetentionStudy Site Management

    Podcast Episode #04: Big Data Comes to Fruition

    by Dan McDonald December 11, 2014
    by Dan McDonald December 11, 2014

    – Data-Driven Approaches to Streamlining Study Planning Processes – Perspectives of big data have done a complete 180 in the last 10 years. Sponsors and CRO’s are seeking to lessen cycle times while simultaneously managing more complex protocols, and they’re seeking new answers. As data-driven…

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Imperial Clinical Research Services Blog

Imperial is a global leader in clinical trial solutions and support, specializing in study and site print materials, ancillary trial supplies and equipment, clinical trial translation management, and clinical trial patient engagement.

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