Almac ONE: One Unified Clinical Trial Supply Solution

Transcription

1 Almac ONE: One Unified Clinical Trial Supply Solution

2 There is ONE solution to solving the challenges of managing multiple supply chain vendors...

3 Almac ONE - Your ONE Unified Solution Solution has redefined the Supply Chain experience to create a responsive end-toend process that bridges the physical and digital connect. The result enhanced visibility and accuracy throughout the lifecycle of your study. Collectively, our expertise integrates patient recruitment, clinical supply and Interactive Response Technology (IRT) strategies with closed-loop technology to enable a holistic data flow that leverages insights to give you greater flexibility and visibility over your clinical supply, resulting in enhanced performance end-to-end. Solution combines the technological and consultative expertise to give you greater visibility and control over your clinical study from start-up to completion. We call this Unified Solution Almac ONE.

4 The evolving landscape of clinical supply management In an ever-evolving landscape, Almac understand the increasingly complex nature of clinical supply management for sponsors with variable recruitment patterns and patient demand leading to disjointed and costly trials, resulting in frequently missed milestones. To create an alignment between the digital and physical clinical supply chain is challenging. The consequence of a fragmented approach managed by multiple vendors, is that vital study data is not aligned creating additional layers of complexity resulting in increased risk, time and cost for the sponsor. Solution has the built-in expertise to enable customers to streamline their studies from start-up to completion with seamless efficiency. One Unified Clinical Trial Supply Solution Almac has developed our Almac ONE solution with these challenges in mind. Collectively we have the expertise to offer a unified clinical study experience providing improved data quality and integrity, proactively mitigating risk by substantially reducing errors - saving the sponsor time and money over the lifetime of their study. Almac s One Unified Solution has redefined the supply chain experience to create a responsive end-toend process that not only enhances visibility, accuracy and control throughout the lifecycle of a clinical study, but ensures the seamless integration of process, production and data management. Solution proactively mitigates risk and improves industry efficiencies. One goal Almac s One Unified Solution has one objective to guarantee the study drug is with the patient at the right time while ensuring the complete chain of custody and minimising wastage of drug from production to destruction. Pre-validated patient data 24/7 Technical support services Removal of administration burden Fewer inventory errors

5 One Partner Almac ONE is the only trusted solution which understands the interdependencies between clinical supply services and IRT. With over three decades of experience contributing to the strategic decision making of our sponsors, allowing them to focus on other critical trial activities. One Team Almac ONE is supported by a dedicated team of service delivery leads, these team members work behind the scenes to ensure alignment between the physical and digital integrations that occur across the supply chain at three key levels; project, process and product. Combining their expertise with a closedloop technology system, performing regular cross checks to anticipate and resolve problems, as well as identify opportunities for service personalisation and improvement helps deliver a truly custom-led solution for sponsors. Thus aiding a robust and more meaningful data exchange driving quicker and better decision-making. A unique blend of novel consultative and technology services Solution has the capability of offering a unified view of your data resulting in unique reports and services aiding quicker and more informed decision making. Only ONE team share a common goal with the sponsors to meet key milestones on time and on budget. Combining cross functional expertise and leading technology applications: IRT (IXRS ) + ERP (COSMOS) + Temperature Management (TempEZ TM ) + Forecasting (SupplyWise TM ), this Global Technology Platform has the combined expertise to securely and accurately collect and share pre-validated patient data helping to develop the solutions needed to solve the challenges sponsors face. This enables sponsors to streamline their studies providing a unified view of data achieving Almac ONE s goal of creating optimised, efficient and patient-focused Clinical Supply operations. Greater visibility & control Unified real-time view Improved GDP compliance Improved data quality & integrity Less time & resource required Expert consultants

6 Global Technology Platform Actual patient event data considered in Net Forecast Interactive Response System IXRS Initial forecast Projected patient demand Visit schedule Protocol variables Scenario comparisons Initial forecast Site inventory Patients dispensing events Expiry date Global ERP/MRP Item creation Production planning and execution Inventory management Global Quoting and Invoicing Almac & Depot Inventory considered by MRP Inventory Release* Packaging Manufacturing Drug Order Distribution Global Inventory oversight Central and regional depots (and Sites) Site Order Monitor Registered to shipment Drug Receipt Call/ Quarantine Clinical Site Patient activity Inventory management Temp Data Site Uploads Temp Logger Drug Assignment Quarantine/Release Medication Drug assignments reflected in MRP and Net Forecast * This is automated release through integration with IXRS almacgroup.com GET IN TOUCH Global HQ EU HQ US HQ Durham, NC, USA Asia HQ Japan clinicalservices@almacgroup.com Almac Group Ltd, All rights reserved. AM2615