This blog discusses latest trends and the role technology plays in the life sciences industry. It focuses on Infosys life sciences services and solutions and how they can help accelerate business.

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Clinical Trial Supply Management: A Solution for CROs

Biotech firms of all sizes have come to rely on the specialized services of clinical research organizations (CROs). Doing so is the best way to get their most promising drugs through complicated, multi-tiered trial processes and into the hands of those that need them most: sick patients.

No longer can a single firm attempt to manage these trials without the right suite of solutions. What pharmaceutical companies and CROs alike need are highly effective clinical trial supply management solutions that connect all relevant organizations from beginning to end. Clinical suppliers can instantly relay their status, location, and tracking of information on medications in the supply chain. CTSM solutions involve everything from drug product development, packaging, and distribution to investigational sites, dispensing, inventory, and even return & destruction.

Commercial supply chain solutions lacked the ability to serve the dynamism and flexibility needs of clinical trial supply chains. So, too, have the integration capabilities with interactive response technology and rapid data exchanges needed in the supply chains.

Today's clinical trial supply management solutions are very few. They come with planning & forecasting characteristics, packaging & randomization management, distribution, clinical batch management & country approvals, and analytics. However, a partially pre-configured solution, hosted on a cloud, adds much more than the typical CTSM solutions to the value proposition for smaller but critical entities like CROs. Add to that the wide array of robust Infosys implementation services such as business care preparation, scoping, and business blueprinting.

The readily available documents and accelerators from Infosys include industry business process requirement documents, business process maps, and technical accelerators such as data migration tools, transport management tools, and test automation tools that enhance the time to market significantly and bring CROs on board in three to six months.

To create a seamless experience in the clinical supply chain, an application fostering standardization across data definitions, operating procedures, and data services is the prime need. The CTSM on Cloud by Infosys makes this a reality. Sponsor companies use the same data structures and their contract manufacturers need to align to those standards. That's why an ecosystem of sponsor companies and contract manufacturers continues to grow. Your CRO needs to be a part of this rapidly evolving group.

With an aligned set of data standards, architectural framework, and operating procedures, a robust CTSM solution from Infosys ensures that all companies get high visibility on stocks and the needs of patients. Doing so on a real-time basis allows the CRO to use planning technology that compares planned demands with actual needs and supply chain inventory overcoming the challenges associated with the dynamic nature of demand - supply cycle in clinical trials. It truly suits the need of adaptive trials.

What's key to this new solution is that any process can be happening anywhere on earth - yet the sponsor company knows about every interaction as if it were under its own roof. For example, compliance controls are embedded in processes using technology that considers quality and logistics information. Electronic expiration dating read-outs on Android devices allow companies to control dates by clinical site and patient in more compliant ways.

Consider the Multi-Level Warehouse function. Using an array of scanning tools and barcodes for inventory management, an enterprise can receive the exact location of each medication kit under trial. This highly efficient warehousing operation operates via radio frequency-based scanning transactions. Plus, it's all tied in with SAP's multilevel handling unit for maximum efficiency. Batch numbers are also ties into the SAP software. Specific medication number (serial numbers, really) are given to both supply and replenishment deliveries. Doing so prevents faulty shipments and facilitates returns of unused or expired drugs.

Then there's the question of size. It's not uncommon for some CROs to run thousands of clinical trials for their larger Pharma clients. But there is a growing number of boutique firms and researchers that might only need a handful of test runs. Because the Infosys CTSM solution is scalable, companies receive just-In-time & on-demand solutions for very small trials. CROs can come on board without huge investment and start operating seamlessly with the manufacturers and other entities. It's truly a revolutionary application, bringing Pharma, MROs, CROs, distributors and regulators onto one single platform.

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