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Clinical Trials

    Clinical trial efficiencies
    Ancillary Trial Supplies and EquipmentClinical Trial Writing and DesignPatient EngagementPatient Recruitment and RetentionSite Materials & LogisticsTranslation of Study Materials

    Clinical Trial Efficiencies: The Power of a Single Workstream

    by Dan McDonald August 18, 2022
    written by Dan McDonald

    The management time needed to corral many different elements during a trial is immense. In the buildup to a research study, clinical operations teams often focus on items such as study startup, site initiation and activation, supply chain, monitoring, data management, and safety. And there is so much more! Finding ways to improve clinical trial efficiencies leads to an easier-to-manage study.

    Some key site needs and patient engagement components that need to be managed include:

    clinical study component list

    Also, consider complicating factors, such as:

    • The growing global footprint of clinical studies
    • The evolution to a decentralized clinical trial model
    • The importance of considering health literacy in educating potential study volunteers, their caregivers, and stakeholders
    • The need to drive greater diversity in clinical trials

    More responsibilities

    In addition to managing all the different elements of a research study, clinical trial project managers are saddled with overseeing as many as eight different vendors, when considering the list of services above. Therefore, they often find two more titles added to their job description:

    • Project manager
    • Vendor manager

    That’s up to eight separate vendors, all with unique requirements culminating in the need for numerous meetings, people, and timelines. Management can be highly complex and disruptive, and wreak havoc on study timelines. These elements are also outside the core competencies of many CROs and sponsors.

    The failure to identify, plan for and synchronize these elements accounts for holes that far too many study teams miss. This leads to unexpected delays and headaches.

     Interconnection of individual components

    Interconnection of clinical trial componentsHow something is written impacts translation. Writing clinical trial content with translation in mind ensures the source text is unambiguous and easy to read. Improved English text also makes it easier to translate, which saves time and money, avoids errors, and improves readability.

    During translation, 20-25 percent (even up to 35 percent in some languages) of text expansion can occur, which impacts formatting. Planning during the initial creative design process can allow for text expansion and contraction without impacting the overall design. Too often these activities are done in a vacuum.

    Vendors that need to be in lockstep often are not. One vendor may not know when they will receive files from another vendor to keep the project moving forward. This creates issues with resource planning and time management.

    Translators need to know when they will receive files from writers. The layout and formatting vendor needs to know when they will receive the translated files. The printer needs to know when they will receive the formatted print-ready files and so on. This takes up personnel time to communicate with each vendor and time to physically move files from one vendor to another. Then, if there are amendments or other changes, the cycle starts all over again.

    Opportunities to improve clinical trial efficiencies

    What if all these pieces could be managed together? Combining as many services as possible with one vendor can alleviate the pain and create clinical trial efficiencies.

    The activities I’ve listed need to be considered as a single workstream. When placed into a single workflow and taken together, they can result in a powerful platform for awareness building, education, outreach, engagement, and support.

    Doing so gives study managers tremendous visibility and allows for centralized control over the quality, speed, and cost. Furthermore, it recognizes that these functions are critically linked and that the quality and approach to work on one directly impacts the others.

    Imperial provides a single vendor, a single point of contact, and a dedicated project manager devoted to staying on top of details and timelines to make your study a success. All the above-listed pitfalls are pre-planned for and taken care of behind the scenes to provide our clients with a smooth, hassle-free process.

    Whether creating a single workflow for your study or managing just one essential part, Imperial is ready to help create clinical trial efficiencies.

    August 18, 2022 0 comment
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  • Business InsightsPatient Recruitment and Retention

    Artificial Intelligence for Clinical Trials: Move Ahead, or Halt?

    by Erica Manning July 26, 2022
    by Erica Manning July 26, 2022

    This blog was featured on Clinical Trial AI Weekly. For centuries, science fiction writers have toyed with the endless possibilities of artificial intelligence (AI). And now we’re living the future those writers celebrated and also feared. How might AI apply in the realities of our…

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  • Ancillary Trial Supplies and EquipmentBusiness InsightsLife-Science EventsPatient Recruitment and Retention

    Bridging Research and Health Care: If We Don’t Do it, Someone Else Will

    by Dan McDonald May 21, 2018
    by Dan McDonald May 21, 2018

    I recently had the honor and privilege of representing Imperial at the inaugural Bridging Clinical Research and Clinical Health Care conference in National Harbor, Maryland. It was interesting and worthwhile. The conference brought together heavy hitters and important voices, including the FDA and advocates from…

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  • Life-Science EventsPatient Recruitment and Retention

    The Role of Patient Engagement in the Transition from Lab to Clinic

    by Dan McDonald January 17, 2018
    by Dan McDonald January 17, 2018

    The drug discovery and development process is a complex and challenging landscape, especially for the majority of small biopharmaceutical and medical device companies. It’s truly a survival of the fittest environment, fraught with potential pitfalls and company killers. For every Kite Pharma (acquired by Gilead…

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  • Patient Recruitment and Retention

    You Should Listen in on Patient Conversations

    by Melynda Geurts November 14, 2017
    by Melynda Geurts November 14, 2017

    [pullquote]Social Listening is a Key Tool for Clinical Studies[/pullquote] Getting feedback from potential clinical trial participants has long been part of research programs undertaken in our industry. The typical modus operandi is to seek out the information from a particular group of people through such…

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  • Business InsightsSite Materials & Logistics

    2 Tips for Shipping Your Clinical Supplies Internationally

    by Dan Polkowski May 15, 2017
    by Dan Polkowski May 15, 2017

    Shipping clinical study supplies internationally is an art and a science. Customs departments add an unsympathetic layer of bureaucracy – if paperwork and preparations aren’t in line with the country’s regulations, you can expect headaches that will add costly delays that could impact your study’s…

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  • Business Insights

    Trial App Boosts Patient Engagement

    by Melynda Geurts March 23, 2017
    by Melynda Geurts March 23, 2017

    With patient attrition in clinical trials on the rise, more than ever it is important to provide services that will ease the burden of participation. Studies that require caregiver support have special retention challenges. Sponsors need to engage caregivers with support tools that are created…

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  • Ancillary Trial Supplies and EquipmentSite Materials & LogisticsStudy Site ManagementTranslation of Study Materials

    7 Ancillary Supplies Adventures

    by Hope Cullen March 20, 2017
    by Hope Cullen March 20, 2017

    At Imperial, we know that selecting, procuring, and delivering ancillary supplies for clinical trials isn’t just loading syringes and Fitbits into FedEx boxes and sending them here and there. It’s as varied and challenging as you might imagine. Here are a few of my favorite…

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  • Patient Recruitment and Retention

    The Facts on Patient Enrollment Delays

    by Dan McDonald March 2, 2017
    by Dan McDonald March 2, 2017

    The Undeniable Truth Everyone is aware that patient enrollment is an issue. In a recent report from Tufts Center for the Study of Drug Development on 150 global trials, it was discovered that 9 out of 10 studies eventually achieved enrollment goals, but that it…

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  • Business InsightsPatient Recruitment and Retention

    Behind the Scenes at Trial Sponsor Companies Part 2: Enrollment Plans, Strategies, and Metrics

    by Dan McDonald October 19, 2016
    by Dan McDonald October 19, 2016

    In my last blog post, I wrote about findings from a first-of-its kind survey conducted by Imperial. We surveyed managers and directors of clinical operations, project managers, lead/senior CRAs, and patient recruitment specialists from sponsor companies, and ended up with a behind the scenes look…

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The Imperial blog features content of interest to life-science professionals, with a special focus on clinical trials. We hope you will enjoy our experts’ perspectives, and invite you to join the conversation by leaving your comments. Please let us know of any additional topics you would like to see covered here.

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Imperial Clinical Research Services Blog

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