spacer
home > ict > winter 2020 > the drivers of success in ancillary supply chain management
PUBLICATIONS
International Clinical Trials

The Drivers of Success in Ancillary Supply Chain Management




Today’s pharmaceutical landscape relies increasingly on outsourcing efforts. Meanwhile, global rules, laws, and regulations continue to evolve at a rapid pace, and pressure to expedite market approvals for new drugs mounts. Due to the intertwined factors, a new, extremely complex global ‘ancillary’ supply chain has emerged. In this era of change, how does the ancillary supply chain respond to the needs of a rapidly changing industry and create better outcomes for drug discovery organisations and their patients?

The clinical trial ancillary supply chain (CTASC) – a global, extremely complex, highly variable, unregulated, and decentralised system – manages the flow of non-drug materials to sites for clinical investigator and patient use. Pharma organisations have elected to outsource requirements for ancillary supplies distribution (medical devices, laboratory equipment, patient supplies, etc.) to preferred partners that manage the chain via an integrated, end-to-end process. These preferred partners are staffed with medical professionals, as well as quality, regulatory, and supply chain experts, who conduct protocol and patient dosing schedule analyses, determine product selection based on trial specifications and country of use, review in-country regulatory and equipment licensure requirements, and source and procure supplies to arrive on site prior to first patient first visit (FPFV). A detailed supply plan is presented to the sponsor organisation prior to study kick-off, providing the roadmap by which the CTASC organisation will manage the flow of goods throughout the trial. In addition to the information noted above, the supply plan depicts the processes by which the CTASC will provide support for ongoing import and export regulatory analyses and control, inventory and depot management, estimated timelines for shipments on demand or in advance of patient arrivals, and reclamation and disposition processes for all supplies remaining at each site as the clinical trial closes. To achieve these goals in this highly complex market, CTASC organisations must utilise innovative technology, predictive analytics, and data mining to forecast demands, improve internal and external operations and deliverables, and drive value across the chain and throughout

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
About the author


Dr Joanne Santomauro, CEO and Founder of Ancillare, LP, created the clinical and ancillary supply chain management industry in 2006. Prior to the company’s launch, pharma, biotechnology, contract, and medical research organisations had little transparency to the overall supply chain and had a limited grasp of the associated costs, processes, and regulatory and compliance requirements of this diverse global supply chain. Joanne’s 35 years of supply chain expertise led the company to launch its market-leading model.
joanne.santomauro@ancillare.com
Print this page
Send to a friend
Privacy statement
News and Press Releases

Pistoia Alliance Publishes Free Guide to Accelerate the Implementation of FAIR Principles in Clinical Data

Boston, 25 January 2023, The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D today launched its freely accessible FAIR4Clin guide. The guide will help clinical regulators, biopharmaceutical and healthcare organizations to implement the FAIR principles (Findable, Accessible, Interoperable, Reusable) in clinical datasets. The diversity of data types, standards, and regulatory and privacy requirements, combined with the huge volume of clinical datasets, has presented a particular problem in life sciences R&D. The guide emphasizes the value of FAIR to the clinical space, including making data machine-readable to support AI, innovating in clinical trial design, and enabling the transfer of data between sponsors, CROs, and regulatory agencies. FAIR4Clin was co-authored by the Pistoia Alliance and leading experts in the field, including from AstraZeneca, Bayer, Roche, Genentech, Galapagos, The Hyve, Elixir, The University of Manchester and Oxford University.
More info >>

White Papers

galenIQ - The smart excipient

BENEO GmbH

galenIQ combines a multitude of outstanding characteristics and is suitable for a wide range of pharmaceutical applications. galenIQ can be used as more than just a bulk excipient. It also serves as an anti-caking agent, anti-humectant agent, stabilizer or oral care and taste agent to mention just a few additional functions.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement