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Ancillary Clinical Trial Supplies and Equipment

    Recalls and notices are intended to safeguard patients – and also providers. Failure to follow through can put patient safety in jeopardy and lead to other complications. Ignoring or overlooking these recalls and notices can have far-reaching effects.  
    Ancillary Clinical Trial Supplies and Equipment

    Staying Compliant with Recalls and Safety Notices

    by Ryan Seeley December 8, 2020
    written by Ryan Seeley

    Recalls and notices are intended to safeguard patients – and also providers. Failure to follow through can put patient safety in jeopardy and lead to other complications. Ignoring or overlooking these recalls and notices can have far-reaching effects.  

    Management of recalls and safety notices can be one of the most difficult compliance issues. Critical communications can be easily missed or overlooked.  

    Products need to be traceable and accountable through the supply chain. There is always the possibility that a product will eventually need to be quarantined, recalled, and sometimes even destroyed.  

    Common issues that occur during a recall can be alleviated by knowing how to respond. In any recall, you should: 

    • Not panic! 
    • Know how to retrieve any affected product.  
    • Know what do with the product once received.  
    • Have a documented procedure and follow it.   
    • Test the procedure plan with a mock recall annually. 

    Once a recall is initiated, it’s important to make sure the follow-through is 100 percent. Compliance is not optional — it is the law.  

    It’s paramount to have an effective recall strategy that is tested annually. Following a recall plan through to completion will ensure the plan is effective, thereby keeping patients and providers safe. Having a partner – one like Imperial — that understands the significance of recall compliance can be the difference between life and death in extreme cases and success or failure in complying to important regulations.  

    In short: Have a plan, stay calm, and follow the plan. 

    December 8, 2020 0 comment
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  • Ancillary Clinical Trial Supplies and Equipment

    Managing Lot and Expiry is Not Just for Medications

    by Ryan Seeley September 29, 2020
    by Ryan Seeley September 29, 2020

    In clinical trials, compliance and good clinical practice are necessities to success, and patient safety is always paramount. Every detail is important, including the technical task of managing lot and expiry. Some think lot and expiry are important only when it comes to medication. Not so! Lot…

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  • Ancillary Clinical Trial Supplies and EquipmentClinical Trial Business Insights

    Clinical Trial Logistics: Here’s How to Clear Customs

    by Dan Polkowski May 1, 2019
    by Dan Polkowski May 1, 2019

    Updated: July 11, 2022 An important member of your study team is a person you might never meet! It’s your registered importer, known formally as the importer of record (IOR). When shipping study materials or medical equipment internationally, it is not unusual for them to…

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  • Ancillary Clinical Trial Supplies and EquipmentClinical Trial Business Insights

    You Don’t Know if You Don’t Ask

    by Hope Cullen July 17, 2018
    by Hope Cullen July 17, 2018

    Paper and pencil are so passé. Technology is being used in all types of studies to collect patient data in a myriad of ways. But even the simplest piece of technology is not without its challenges. Take the humble iPad, for example. Or, in this…

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  • Ancillary Clinical Trial Supplies and EquipmentClinical Trial Business InsightsClinical Trial Life-Science EventsParticipant Engagement

    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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  • Ancillary Clinical Trial Supplies and EquipmentClinical Trial Business Insights

    Pre-approval communications prior to export: Why are they so important?

    by Dan Polkowski May 3, 2018
    by Dan Polkowski May 3, 2018

    The best way to answer this question is with the catchphrase a chain is only as strong as its weakest link.  After 25 years of managing global clinical trial studies for clients, I cannot emphasize enough how much this phrase relates to the global distribution…

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  • Ancillary Clinical Trial Supplies and Equipment

    Shipping Globally? Who is Your Importer of Record?

    by Dan Polkowski February 8, 2018
    by Dan Polkowski February 8, 2018

    Planning to export an ancillary supply or a medical device? Get ready for some bureaucratic red tape. Country governments take compliance with their import and export laws and regulations seriously. If a violation occurs, the in-country importer of record could find itself facing fines, penalties,…

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  • Ancillary Clinical Trial Supplies and EquipmentSite Materials & Logistics

    7 Questions to Ask Your Ancillary Supplies Vendor

    by Hope Cullen June 26, 2017
    by Hope Cullen June 26, 2017

    It’s common for sponsors and CROs to work with vendors to acquire ancillary supplies and ship them to sites. From the outset, it is important to fully understand your vendor’s capabilities and range of services to make sure you can attain your goals. Asking the…

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  • Ancillary Clinical Trial Supplies and EquipmentSite Materials & Logistics

    Ordering Study Supplies? Do You Need to Consider the Sunshine Act?

    by Hope Cullen June 19, 2017
    by Hope Cullen June 19, 2017

      We have found that many studies neglect to have plans in place regarding the Sunshine Act. Don’t overlook this! Sunshine Act reporting is required in clinical studies, and it should be included in planning your activities to ensure reporting compliance. The Sunshine Act, specifically…

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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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