Implementing a Stability Strategy for Short Expiry IMPs
Summary: Different clinical trials have different supply needs and strategies. This recent Q&A article published in Pharmaceutical Technology features…
read moreStrategies to Keep the Critical Path Clear: Understanding How Study Design Can Impact Clinical Supply Availability and Efficiency
Summary: This eBook explores the multitude of factors that can impact clinical supplies and techniques and strategies that clinical supply professionals can apply to keep clinical supplies off the critical path…
read moreManaging Risks to Time Critical Product Imports at Clinical Supply Depots
Summary: A Catalent customer wanted to run a clinical trial in Israel and was arranging to ship their clinical trial product from a non-Catalent facility in Europe to a Catalent-managed and audited depot in Israel…
read moreQP Perspective On Brexit
Summary: Explore how Brexit may change the working relationship between Qualified Persons (QPs) in the UK and EU through a moderated Q&A roundtable.
read moreCountdown To Brexit: Can Your Clinical Supply Chain Pass The Brexit Pressure Test?
Summary: Developed by a cross-functional team of Catalent experts, this whitepaper is intended to help sponsors understand how the various Brexit outcome scenarios may specifically impact clinical supplies. In this paper, you will find more than 30 practical questions that you can explore internally to evaluate…
read moreInnovative Strategies To Maintain Product Integrity In Biologic & Biosimilar Clinical Studies
Summary: Delays encountered during clinical studies can have a serious impact on competitive advantage, speed to market and the availability of lower-cost alternatives for patients. Specialized expertise in cold chain shipping and logistics are critical to avoid costly delays…
read moreClinical Supply Trial Perspectives: Challenges Facing Small, Mid-sized & Large BioPharma Companies
Summary: From delays in the study timeline to budget constraints and regulatory requirements, the challenges associated with management and execution of clinical supplies are many and varied.
read moreEstablishing Parameters For Success
Summary: Applying clinical supply management expertise to overcome inventory challenges for a complex, global study. A CRO customer and clinical sponsor both lacked an unblinded supply management role to oversee Interactive Response Technologies platform (IRT) supply strategies and monitor clinical supply…
read moreIs Your Clinical Supply Playbook Ready For Phase II & Beyond?
Webinar Summary: Advancing promising investigational medicines to Phase II and beyond for the first time is an exciting time for clinical sponsors with young pipelines – and an eye opening one as well. Experience has shown that certain study characteristics can act as useful leading indicators of future clinical supply challenges…
read moreGlobal Clinical Trials: Integrated Solutions. Reduced Timelines.
With our expertise and capacity across every phase of development, we offer you the peace of mind that comes from having one company manage your supply chain throughout your product’s entire lifecycle…
read moreShould Your Next Clinical Trial Use A New Supply Model?
Webinar Summary: Whether you are currently determining the best clinical supply model for an upcoming study or would like to learn more about new approaches to clinical supply this webinar will help you identify strategies to reduce supply chain risk and improve performance…
read moreNavigating Common Clinical Supply Challenges For Asia-Pacific Regional Studies
Summary: Unlike well-established clinical trial regions, such as Europe which benefit from more harmonized regulatory requirements and quality standards and transportation networks, the APAC region is a collection of independent countries each with its own infrastructure limitations, clinical supply quality standards, regulations, and protocols…
read moreLeveraging Forecasting Models To Optimize Clinical Trial Supply Management
Summary: Explore how to drive excellence within the forecasting process and how to utilize forecasting throughout the study to plan for study clinical supply budgets and identify potential supply-related issues before they negatively impact your study…
read moreThe Medicine Maker – More Trial, Less Error
Summary: The pressure for increased efficiency pervades the pharma industry, including the clinical trials sector, where traditional supply models can lead to overstocking, waste and higher costs. This article, originally published in “The Medicine Maker” explores if there is a more effective supply strategy…
read moreOptimizing Your Clinical Supply Chain Strategy For Asia-Pacific Studies
Summary: Unlike Europe where clinical trial regulations are largely standardized between the EMEA member states, no such organization or harmonization exists in the APAC region, making conducting multi-country studies within the region much more complex for clinical sponsors, particularly with regards to the sourcing…
read moreClinical Trials Innovations
Summary: Developing, implementing, and managing a clinical trial involves coordination of multiple factors in an ever-changing environment. Recent innovations in trial design and management including a demand-led approach to drug supply, adaptive trial design, mHealth for patient-centric and site-centric trials…
read moreMaintaining Product Integrity In Biologic & Biosimilar Clinical Studies
Summary: Specialized expertise in cold chain shipping and logistics are critical to avoid costly delays and potential for patient harm resulting from an interruption or delay in necessary clinical supply. Maintaining product integrity and reliability of supply can be especially challenging for biologic and biosimilar studies as the investigational…
read moreIdentifying & Addressing The Hidden Root Causes Of Supply Chain Inefficiency
Summary: Delayed. Out of stock. Over-budget. Unavailable…All words that clinical trial sponsors never wish to hear in reference to the impact of supply chain performance on their study. And yet, considering the critical role the supply chain plays, it has surprisingly remained largely unchanged for several decades…
read moreAround The World In Clinical Trials: New Regulations & Country Specific Challenges
Summary: While thorough knowledge of a country’s regulatory requirements is critical, understanding both the written and unwritten regional differences and business practices that come in to play that can make the difference between clinical supplies moving successfully between countries, being detained in Customs…
read moreAround The World In Clinical Trials: New Regulations & Country-Specific Challenges
As certain regions of the world are added to a clinical study, the logistical and regulatory challenges associated with clinical trial supply distribution can rise exponentially. While having thorough knowledge of a country’s regulatory requirements is critical, understanding both written and unwritten regional rules…
read moreBusiness & Cultural Considerations For Managing The Flow Of Clinical Supplies To Asia Pacific Studies
Successfully navigating the rich and diverse Asia-Pacific business and cultural environment can prove tricky for Western study sponsors with limited experience in this region. Learn what cultural and business norms study sponsors need to be sensitive about in various countries and regions…
Questions You Need To Ask About Clinical Supply
Planning to use a CRO to support your next clinical study? Here are the top 9 questions you should always ask to help your CRO or partner of choice better understand your clinical supply needs.
read morePractical Considerations For Making Clinical Studies More Patient Centric
Successfully sourcing commercial products for comparative studies in an effective and efficient manner often proves far more challenging than assumed. A comprehensive plan should include insight from comparator sourcing and clinical supply management. Tight collaboration between these critical functional…
read moreExpecting The Unexpected: Strategies For Efficient Clinical Supply Management & Forecasting
A proactive approach for effective clinical supply management is essential for reducing the risk of supply-related delays, stock-outs and excess inventory. Utilizing simulations to performing “What If” scenario planning for demand forecasting is a powerful…
read moreNavigating Clinical Supply Challenges In Emerging Regions
The logistical and regulatory challenges associated with clinical trial supply distribution can rise exponentially when certain regions of the world are included. Underestimating the complexity of the logistics involved in the handling of sensitive and highly regulated materials such as clinical supplies has the very real potential…
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