FEATURED ARTICLES

GettyImages-1359811901 The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups

How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.

  • Compelling Advantages Of Creating A Patient-Centric Supply Chain

    Marken’s Nina Vas, discusses everything from global regulatory and trade compliance proficiency to the importance of a secure, closed-loop environment with regard to developing a patient-centric supply chain.

  • Accelerating Timelines By Planning For Clinical Supplies In Advance

    Discover approaches in support of accelerated development timelines, including adopting a single vendor approach, engaging experts earlier in the development cycle, and performing timeline steps in parallel versus linearly.

  • Cell & Gene Therapies Require the Right Tracking Solution

    In cell therapy trials, the ability to track a patient’s cells is essential. When you have over 100 patients, and the cells will require multiple shipments, using a spreadsheet is not possible. “For the safety of our patient, accurate tracking is a must,” says Gerald Garrett, VP of clinical operations for MarkerTherapeutics. “We need to know exactly where the product is at any step of the way.”

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SERVICES & PRODUCTS

PCI provides insightful and multifaceted solutions for addressing patient compliance and adherence for clinical investigational medicines as well as commercial applications.

PCI offers the experience and insights of over 30 years in the storage and distribution of clinical trial materials, effectively storing and shipping thousands of patient kits to over 100 existing and emerging clinical trial countries across the world.

Our comprehensive service offering includes early stage formulation and analytical development, API capsule and vial filling using Xcelodose® technology, scale-up and stability testing, process validation, technology transfer and associated analytical support services.

Rigorous attention to detail is paramount to the successful execution of global clinical trials.

Pharmaceutical companies face continued pressure to develop and commercialize their medicines. PCI Clinical Services is committed to supporting clients at every stage of the clinical cycle, delivering best-in-class services efficiently and effectively.

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For more than 25 years, Bellwyck has been a true partner in developing smarter solutions for the pharmaceutical industry — from clinical trial to commercialization. Our consulting services start with a dedicated project management team led by a single point of contact throughout your project.

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