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CONTENTS


Contents


5. 6.


Chapter 1: Outsourcing supply operations


Integrating new technologies for temperature-sensitive supply chains Why innovation to improve temperature-sensitive shipments is on TSafe’s agenda


8.


3D printing in drug manufacturing: unlocking future possibilities


How 3D printing has potential in the democratisation of drug access


12.


A retrospective of the COVID-19 pandemic and its effect on clinical trials Abacus Medicine Pharma Services reflects on the challenges of COVID-19


14.


US Pharmacopeia report finds high reliance on Indian manufacturers for APIs The ongoing dependency on overseas manufacturers


16.


Just-in-time: on schedule to rescue the clinical trial supply chain? The benefits of just-in-time to clinical trials amid global supply chain pressures


20.


Risk management of clinical trial supplies Clinical Services International on sourcing comparator or co-medication in clinical trials


46.


23. 24.


Chapter 2: Technology and innovation


Injectable opportunities for CMOs despite internal capacity of big pharma sponsors Why companies are turning to outsourcing to meet market demand for injectables


26.


Continuous manufacturing builds on hype but adoption remains gradual The drive towards continuous manufacturing


4 | Clinical Trial Supply Handbook 37. 30.


IRT in clinical trials; what to add to your shopping list Essential advice on finding the right provider of IRT software solutions


33. 34.


Chapter 3: Supply and logistics


Navigating delivery and access challenges for rare disease drugs How specialty pharmacies and value-based contracts could shape niche drug distribution


A perfect storm: pandemic adds further burden to CAR-T development The continued impact of COVID-19 across the CAR T-cell therapy industry


39.


Cutting the carbon footprint of pharma’s supply chain Tackling carbon emissions means targeting the whole value chain


43. 44.


Chapter 4: Future supply models


Breaking silos will be key in future- proofing clinical trial supply chains Why future-proofing means getting the data, innovation and governance right


Direct to patient: the rocky road to remote drug delivery in clinical trials The opportunities in sending investigational drugs directly to study participants


49.


Insulin pricing: could an e-commerce approach cut costs? Electronic selling could mitigate spiralling insulin prices


52. Suppliers’ directory


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