Catalent.com Contact Us SOLUTIONS SERVICES LOCATIONS EXPERT CONTENT NEWS & EVENTS ABOUT US CAREERS FUSION Home » Expert Content BROWSE BY TOPIC: VIEW ALL COMPARATOR SOURCING CLINICAL SUPPLY MANAGEMENT CLINICAL PACKAGING & DISTRIBUTION SERVICES TYPE: VIEW ALL ARTICLE BROCHURE CASE STUDY EBOOK EXECUTIVE SUMMARY INFOGRAPHIC OFFERING FACT SHEET VIDEO WEBINARS WHITE PAPERS Clinical Supplies for Japan Studies Summary: Catalent’s clinical supply packaging facility in Shiga, Japan is strategically located between Tokyo and Osaka. One of largest in Japan, the 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global… read more Bridging the Cell and Gene Therapy Gap Between Manufacture and Supply Chain The current understanding among sponsors of the workflow from cell collection, to manufacturing, and ultimately to the clinical site for patient administration. read more OneBio® Integrated Suite Offering Fact Sheet-OneBio® Integrated Suite read more OptiForm® Total Supply Offering Fact Sheet – OptiForm® Total Supply read more Understanding the Impact of Primary Packaging Decisions on Clinical Supply Success Explore how an experienced partner can provide invaluable guidance and offer creative solutions when selecting a primary packaging format. read more Risk Mitigation in Direct-to-Patient Clinical Trials The benefits of direct-to-patient supply to mitigate risk in decentralized studies. read more Optimizing Clinical Supply for a Smoother Phase 2a to 2b Transition The reasons behind implementing a multi-segment Phase 2 study and implications on kit design. read more Proactive Clinical Supply Planning: Optimizing Strategies from Early through Late Phase Proactive Clinical Supply Planning-Early to Late Phase read more Aligning Clinical Supply Strategy with the Target Product Profile for your Clients Management of advanced supply chain CMC collaborators and CDMO partners. read more WHO, WHEN, WHERE and HOW? The Key Clinical Supply Issues Sponsors Should Consider with their CROs The importance of project management, and key elements to consider to help keep trials on time and budget. read more A Global Sponsor’s Guide to Successful Clinical Supply in Japan Explore key aspects of Japan’s regulatory environment to consider when developing a clinical supply plan and associated timelines. read more Clinical Supply Planning for Studies with Unconventional Timelines Learn how unconventional trials impact the supply chain and the role a CDMO can play in facilitating these studies. read more Planning Ahead: Using Phase 1 to Anticipate Phase 2 Clinical Supply Learn what clinical sponsors should look for when assessing integrated services and potential providers. read more Optimizing Direct-to-Patient Clinical Supply for Decentralized Clinical Trials How adopting the decentralized trial approach introduces new challenges for companies hoping to ramp up an early phase trial or keep later stage studies going during the pandemic. read more Decentralization: A Direct Approach to Clinical Trials Benefits of decentralized trials to sponsors and patients. read more Industry Perspective: Defining the Optimal Clinical Supply Strategy for Cell/Gene Therapy Studies Insight into the current level of integration between the manufacturing and supply chain used and sought by cell/gene therapy companies. read more Building a Flexible, Challenge Resistant and Patient Centric Clinical Supply Chain Learn strategies to improve supply chain efficiency, reduce risk and respond to local, regional and global challenges. read more Leveraging Effective Clinical Supply Strategies to Meet Complex Challenges in China and APAC ( Chinese ) How Catalent’s integrated and innovative model can help to ensure timely and optimal clinical supply execution in the APAC region. read more Optimizing Resupply to Reduce Risk of Late Phase Delays Learn ways that clinical supply strategies for late phase vary from early phase. read more Comprehensive Clinical Supply Strategy for Compressed Timeline Trials Strategies sponsors can enable with a supply partner in order to minimize project risk. read more The APAC Advantages Cultural considerations when planning and implementing an APAC clinical supply strategy. read more Fastchain® Demand Led Supply Summary: FastChain® demand led supply is a continuous GMP approach to secondary packaging, label printing and application, release, and regional distribution of patient kits to clinical sites based upon actual patient and site need. The FastChain® approach will… read more Innovative Solutions to Meet the Complex Pharmaceutical Supply Challenges Summary: Integrated approach from development to clinical and benefits of working with a single integrated provider. read more Planning Ahead: Using Phase 1 to Anticipate Phase 2 Clinical Supply Challenges and Solutions Summary: Utilizing an integrated solution with a single provider can help ensure a smooth transition from Phase 1 into Phase 2. read more Excellence in Operating Multi-Center Clinical Trials Summary: As the clinical development market evolves rapidly in China, a rising number of multi-national companies are initiating early phase clinical trials in China in parallel with other sponsor countries. read more Discover the Latest Funding, Drug Development and Clinical Solutions Strategies Summary: View this exclusive webcast specifically designed for pharmaceutical & biotech consultants and early stage development partners. Hear three early drug development industry experts present… read more Planning Ahead: Using Phase 2 to Anticipate Phase 3 Clinical Supply Challenges and Solutions Summary: Discover what challenges can occur in Phase 3 and how to address them in advance to limit potential setbacks. read more Building a Flexible, Challenge Resistant and Patient Centric Clinical Supply Chain Summary: Explore strategies to improve supply chain efficiency, reduce risk and respond to local, regional and global challenges. read more Forecasting to Optimize Clinical Trial Supply Management Summary: Learn about forecasting solutions for better informed decision making and contingency planning in these inherently dynamic trials. read more Early Drug Development Strategies for Clinical Success Summary: Every clinical study is different, each with its own unique characteristics and requirements. The optimal time to begin planning a clinical supply strategy is while the study… read more Understanding Options in Direct-to-Patient Clinical Supply Summary: This video explores several approaches to direct-to-patient clinical supply that are in use today and how they can be used to flexibly support today’s decentralized clinical trials. read more Designing an Optimal APAC Clinical Supply Chain – What Every Sponsor Should Know Learn how to navigate the complex clinical supply distribution landscape within this important and growing region. read more From Local Trials to Across the Globe: Considerations for Managing an Effective Clinical Supply Chain in Asia As clinical study activity continues to grow across APAC, some countries have been looking to improve upon their compliance requirements to help make the distribution of clinical supplies throughout the region more efficient. read more Pragmatic Insights from Clinical Supply Management and EU Qualified Persons on How to Optimize Global Clinical Studies Summary: After 3 years of Brexit withdrawal negotiations, the UK is officially no longer a member of the European Union. Clinical sponsors with active and planned studies in the EU… read more Accelerating Timelines by Planning for Clinical Supplies in Advance Developing a clinical supply strategy early is key to minimizing risk and avoiding delays when implementing and executing accelerated study timelines. read more Why Blister Packaging: Things to Consider As the number of global scale clinical trials continues to grow, sponsors will need to implement methods to ensure their protocols are executed properly. read more Important Considerations in the Packaging of Clinical Supplies Clinical supply packaging strategies can greatly impact the ability to properly execute study protocols. read more Supply Chain Models for Global Trials – Singapore as the APAC Gateway to the World Summary: In 2018, over 40% of new clinical studies had sites in the APAC region this trend is expected to continue to grow in the coming years. read more Clinical Trial Challenges Amid COVID-19 Summary: Due to the influx of COVID-19 related therapies being expedited into clinical testing, studies in other areas are either proceeding with heightened caution or are essentially being… read more Direct-to-Patient Supply: Industry Perception and Future Trends Summary: Catalent and Fierce Pharma surveyed 234 individuals involved in clinical supply and clinical operations to better understand the industry perception around importance of having a direct-to-patient option… read more CTSuccess™ Summary: Proactive clinical supply risk evaluation and tailored strategies to support on-time study start-up for small and mid-sized sponsors… read more APAC Region Distribution Considerations for Clinical Trial Supplies Summary: The Asia-Pacific (APAC) region has become an emerging market for pharmaceutical and biotech innovation, including clinical studies. Managing a clinical supply distribution strategy within APAC… read more Beyond Brexit: What Now for Clinical Supply Across Europe Summary: After 3 years of Brexit withdrawal negotiations, the UK is officially no longer a member of the European Union. Clinical sponsors with active and planned studies in the EU… read more Minimizing Bias When Blinding and Masking Drug Products Summary: Overcoming complex blinding and masking challenges in clinical trials requires a balance of strategy and adaptability. When conducting clinical trials… read more Direct-to-Patient Clinical Supply Services Summary: With the growth in semi and fully remote clinical studies, the ability to offer direct-to-patient distribution of clinical supplies is becoming increasingly important for clinical… read more Supply Chain Models for Global Trials – Singapore as the APAC Gateway to the World Summary: With an increasing number of clinical studies being conducted in the Asia-Pacific (APAC) region, there is a growing need for streamlining import and export strategies… read more Beyond the Buy: The Critical Role of Data, Relationships, and Experience in Comparator Sourcing Ensuring an adequate, timely, and quality supply of comparator product for clinical trials is critical, but clinical trial sponsors face several challenges in this endeavor. read more How to Avoid Delays in Clinical Supply- Strategies for Comparator Sourcing Ensuring an adequate, timely, and quality supply of comparator product for clinical trials is critical, but clinical trial sponsors face several challenges in this endeavor. read more The Product Development Superhighway: Leveraging End-to-End Solutions for Market Success Summary: Formulating drugs for optimal stability and bioavailability is fundamental to the development of new pharmaceutical products. Once developed, these products must then be delivered… read more Perceptions, Myths and New Thinking on Direct-to-Patient Clinical Supply Summary: Direct-to-patient (DTP) distribution of clinical supplies provides trial sponsors with the opportunity to support improved recruitment and retention rates for their studies by removing or reducing the travel… read more Expanded Access and Commercial Packaging Strategies for Orphan, Niche, and Low-Volume Drugs Summary: Most commercial contract drug packagers do not provide consistent scheduling for low-volume drugs, which creates supply challenges. In fact, a drug packaging delay can create a market shortage that triggers… read more Accelerating Clinical Supply in China and Beyond Summary: Accelerating the flow of clinical supplies both into and out of China can be accomplished using a dual-supply site model. Learn how this approach leverages both… read more The Art of Recognizing Clinical Supply Risk Factors Summary: No two studies are the same and each clinical supply project carries unique risks. Experienced supply chain managers know that certain study characteristics are often leading indicators that they can… read more Global Advantage with Free Trade Zones in China | Catalent in 90 Seconds Summary: Free trade zones offer many advantages for our customers interested in clinical trial supply. The zone provides fast, safe and secure transit to controlled storage situation which can delay or… read more Catalent Softgel Marks Milestone in China Summary: Catalent Pharma Solutions, the global leader in drug development solutions and advanced delivery technologies for pharmaceutical, biologic and consumer health products, announced two… read more Demand Led Services and Clinical Supply Efficiency | Catalent in 90 Seconds Summary: The traditional clinical supply model is a static, linear stock based approach that uses bulk storage to ship to depots based on anticipated demand. The supply for an entire clinical trial… read more Comparator and Marketed Drug Sourcing Solutions | Catalent in 90 Seconds Summary: Our in-house pharmaceutical sourcing specialists utilize a global network of leading manufacturers, wholesalers, and carefully selected QA-qualified healthcare professionals to… read more Overencapsulation of Solid Oral Dose Summary: Covering virtually all dosage forms, we provide a comprehensive, full-service, and vertically integrated operation for clinical trial materials preparation in support of Phase I through… read more High Speed Blistering Summary: With more than 70 years of sterile manufacturing experience with injectables and a global infrastructure of cGMP and FDA-compliant facilities, we have the expertise, processes… read more Automated Plunger Rod Insertion Summary: With more than 70 years of sterile manufacturing experience with injectables and a global infrastructure of cGMP and FDA-compliant facilities, we have the expertise, processes… read more Catalent’s Integrated Clinical Supply Services Summary: A short video on Catalent’s flexible and innovative clinical supply services for phase 1-4 clinical trial sponsors. We have the deep expertise, global capabilities and… read more Blinding of Clinical Supplies Summary: Catalent understands there are numerous ways to approach the various facets of blinding drugs for use in a clinical trial. Employing the right blinding strategy can… read more Expediting Path to Clinic with OptiForm® Total Supply Summary: MGB Biopharma, a biotech company based in Scotland, U.K. was developing a new class of anti-infective medicine based on Minor Groove Binder compounds… read more Shortening Timelines with Clinical Trial Strategy Summary: Biologic clinical trials can be complex with many factors to consider. Understanding your specific needs and developing a plan early on during drug development can… read more Geographic Advantage- Accelerating Clinical Supply in China & Global Trials Summary: Free trade zones (FTZ) in China provide clinical sponsors with specially designated areas to receive materials produced outside of China for the packaging, storage, and distribution… read more How Protocol Design Drives Comparator Sourcing Cost, Timelines, Complexity and Risk Summary: Clinical trials are conducted according to a protocol, which is the master action plan for how the study will be conducted. Clinical trial protocol design can have a significant impact on the sourcing… read more How Protocol Design Drives Comparator Sourcing Cost, Timelines, Complexity and Risk Summary: Clinical trial protocol design can have a significant impact on the commercial drug sourcing strategy for a study requiring comparators. Learn the appropriate level of detail to include in the study protocol… read more Clinical Supply Services Offerings and Capabilities Summary: As a worldwide clinical supply services leader, Catalent has the scale, expertise, and innovative solutions to improve efficiency and reduce your trial timelines. read more 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. read more Primary Packaging Summary: Planning a clinical supply program? Don’t overlook primary packaging! read more Expanded Access and Commercial Packaging Strategies for Orphan, Niche, and Low-Volume Drugs Summary: Securing timely and reliable commercial packaging services can be challenging for orphan, niche, and other low-volume drugs that must compete against high-volume drugs for access to finite production capacity at contract packagers This webinar describes one solution… read more Innovative & Flexible Solutions for an E2E Patient Centric, Lean Clinical Supply Chain Summary: The trend toward crafting patient-centric clinical trials hold great promise in supporting patients’ willingness and ability to participate in important clinical research. However, for sponsors who are embracing the promise… read more 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 more Strategies 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 more Managing 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 more 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. read more Countdown 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 more Innovative 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 more Clinical 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 more 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… read more 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… read more 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… read more Global Comparator Sourcing: Tailored Comparator Solutions, Support, & Expertise – Anywhere in the World When you use Catalent for pharmaceutical sourcing, you get a global distribution network that can deliver what you need, where you need it and when you need it. Always in the right condition… read more 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… read more 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… read more 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… read more 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… read more 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… read more Leveraging 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 more 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… read more 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… read more 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… read more 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… read more 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… read more Identifying & 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 more Around 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 more Around 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 more Business & 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… read more 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 more Practical 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 more An Innovative Solution To Flexibly Meet Unique Primary Packaging Requirements A Case Study – Innovative primary packaging solutions read more Expecting 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 more 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… read more Beyond The Buy: The Critical Role Of Data, Relationships, & Experience In Comparator Sourcing Success 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… read more Expert Content Subscribe Investors Contact Us Site Map Follow Us. Share Us. 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