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Advances in clinical supply models. Innovations in packaging and cold chain distribution. Proven results from our team of clinical supply experts.

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EXPERT CONTENT

Advances in clinical supply models. Innovations in packaging and cold chain distribution. Proven results from our team of clinical supply experts.

VISIT OUR YOUTUBE CHANNEL

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Leveraging End-to-End Solutions for Market Success

Get insights on how contracting with a single service provider can offer significant benefits to the customer through integrated expertise between the formulation development teams, the manufacturing teams, clinical supply specialists, and the packaging teams.

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QP 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.

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Establishing 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…

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The Importance Of Proactive Clinical Returns Planning

Summary: Accurate and timely delivery of clinical trial supplies helps to ensure that a study’s timeline stays on track. Sponsors often focus on upfront planning to ensure sites are prepared to reach clinical milestones but ignore the logistical challenges of reconciling and destroying clinical returns. Dianne Coughlan, Global…

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Is 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…

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Comparator Drug Sourcing Solutions – Catalent’s Network Effects

Summary: A well-known, mid-size, multi-national pharmaceutical company needed a large supply of comparator drug, in order to begin comparative clinical trials for a rare disease. In addition to quantity, the comparator drug must have an expiry-term long enough for the client to complete the multi-year clinical trials…

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Innovative Clinical Supply Solutions – Cold Chain

Summary: With our team of packaging experts and extensive cold chain capabilities, this case study discusses the creation of a custom packaging and distribution solution to meet this client’s unique needs. Through our partnership, the product was successfully packaged in sufficient quantity and on time for the Phase I trial…

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Frozen Drug Packaging

Summary: A biopharmaceutical company known for the development of novel therapeutic drugs had a critical requirement to package a biohazardous frozen drug product. However, the client possessed no stability data at the project onset; an essential parameter in determining the need to keep the product frozen…

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Navigating Logistics Of Global Clinical Trial

Summary: With the increase in global clinical trials has come a renewed effort to harmonize regulations, enhance clinical research infrastructure around the world, and improve protections for patients who participate. Despite many advances in recent years, however, there are numerous logistical challenges to successful completion…

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Should 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…

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Navigating 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…

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The 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…

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Comparator Sourcing

Summary: Pharmaceutical companies face a number of challenges when sourcing comparator compounds for clinical trials, including addressing product lead times, availability, expiry limitations, safety or cost. This eBook illustrates how clinical trial sponsors can determine the best strategy to meet these challenges…

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Optimizing 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…

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Clinical 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…

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Maintaining 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…

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Navigating 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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