Introduction

Monitoring of clinical supply inventory throughout the supply chain is essential in order to monitor study kit usage and available stock levels, ensure the drug is always available for patients, minimise waste medication, alert sites in case of potential supply delays and comply with GMP/ GCP conditions.

SOLO addresses the very unique requirements of Clinical Supply Management, encompassing everything from receiving and storing clinical trial supplies to the shipment, return and destruction of the packaged patient kits.

SOLO software tracks and reports on all the aspects of the storage and distribution of supplies.

SOLO allows increased inventory visibility across supply chain to ensure proper control over stocks at various own or partner warehouses to reduce company’s inventory carrying costs.

It also reduce inventory overage and track clinical supply lots by managing the shelf life expiration date throughout the supply chain.

The key features and benefits of SOLO are:

•Inventory of Warehouses, Depot Types, Temperature Monitors and Packaging Material.

•Management of Project Sponsor Data.

•Management of IP, CMP and non-IP/CTM Projects and Sub-Projects across different countries.

•Maintain information on products and supplies relating to projects.

•Provide traceability of Sponsor requested movement of products/supplies between depots and site.

•Generation of reports relating to the above activities.

•Provision of multi-language/country support.

•Provide limited, secure user access within predefined roles.

•Incorporation of a fully functioning audit trail and integrated supervisor check on key actions.

Marken Solo™ was developed to provide our clients with a state-of-the art system to manage all information and inventory for clinical trials throughout the life cycle.

Marken Solo™ is a cloud-based inventory management system with just-in-time access to global stock levels. Solo™ supplies end-to-end control and visibility of all inventory maintained at the depot, including investigational product, concomitant medication and all ancillary material.

Benefits of the Marken Solo™ inventory management system:

•Secure and validated in accordance with 21 CFR part 11

•Fully accessible 24/7 from any location

•Provides study reporting with inventory visibility and lot-related tracking information across the entire supply chain

•Interfacing with multiple client systems supplies

•Solo™ provides you with inventory levels and enables you to be sure that the right amount of product is delivered to the right place at the right time.