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Friday, April 19, 2024

ICON: Delivering Flexible and Cost-Efficient CRO Services

The pharmaceutical industry is under muchtension in developing of drugs/devices todaydue to stricter regulations, changing technologies, and globalization, which stresses the current operational models and information infrastructure to the limits. Besides, the increasing pressure to constrain costs and expenditure while replenishing the dwindling development pipeline has remained unabated over the past few decades. As these pressures continue to intensify, applying the right methodology to anticipate the challenges that may arise during clinical trials is critical to drivingany project’s success.

Now, a new league of service providers emergesin this space, featuring cutting-edge contact research solutions with a flexible approach to improve cycle times, constrain costs, and reduce risks in drug/device discovery and development. At the helm of this is ICON, a Dublin-based CRO providing a broad range of clinical, consulting, and commercial services to assist pharmaceutical, biotechnology, and medical device companies in bringing new drugs and devices to the market faster. “Our services span the entire development lifecycle of the clients’ product, and are highly adaptable to suit both small local trials andmassive global programs,” saysDr. Steel Cutler, CEO of ICON.

Specializing in the planning, management, execution, and analysis of Phase I-IV clinical trials since 1990, ICON provides an integrated suite of therapeutic, regulatory, and operational services to meet project deadlines consistently. The company’s core competency in project management is endorsed by its comprehensive and consistent processes that resonate with global regulatory requirements. As a full-service CRO, ICON assist clients right from start-up to completion of their projects by undertakingperformance monitoring against contractual timelines and project cost tracking to ensure budget adherence. “ICON offers a range of consulting, standalone, or full-service integrated solutions that are geared toward our client’s successful project completion,” adds Cutler.

On the flipside, ICON provides the knowledge, software, systems, and global footprint to initiate design, simulation, and execution of adaptive clinical trials, thereby enabling sponsors to increase portfolio valuation andminimize product failure. The company’s extensive experience in this domain also helps pharma clients to improve their decision-making at critical junctures in the development process and expedite market access through cost-effective solutions.“ICON is the only CRO to offer a robust platform for adaptive clinical trials, which is used by regulatory agencies around the world, including the US FDA, Europe EMA, and Japan PMDA,” continues Cutler. Additionally, clients can also leverage itsindustry-leading team of experts in adaptive design and execution at theAdaptive Trial Innovation Centre to glean real-world expertise in the area.

As biosimilar medicines promise to be an attractive offering to provide healthcare organizations, physicians, and patients with a better choice and cost-effective alternative, ICON offers a fully integrated approach to jumpstart biosimilars development. This empowers clients to choose the right target moleculesand finalize the optimal growth and commercial strategyrequired to drive market reach. Moreover, the company also possesses the expertise and insights needed tostreamline drug development and regulatory conditions while bringing the operational capability to complete programs on time.Having a strong, proven track record in strategic consulting across the entire productdevelopment continuum, ICON provides clients with a flexible and best-in-class approach to improve cycle times, constrain costs, and reduce risks.

With over 30 years of industryexpertise in the CRO landscape, ICON offers unmatched support for regulatory strategy planning and development for all sections of INDs, CTAs, MAAs, and NDAs, andensures adherence to GMP and GLP compliance. Alongside, its operational and consulting excellenceare always available to assist clients to achieve product authorization through strategic design,real-world evidence studies, and later phase research.ICON not just stops there but also hones the full capability to assist clients in their preclinical and non-clinical development, chemistry manufacturing, controls, and more. Apart from this, the company also features in-depth knowledge in integrated market access, pricing, communications, and health economics, which boils down to strategic guidance and tactical solutions to drive product adoption and brand success around the globe.

For decades, ICON has served as a trusted partner for pharmaceutical clients in early phase clinical research, bioanalytical, PK/PD modeling and simulation, and full-rangesupporting services, leveraging its scientific excellence and exceptional development strategy at every stage. Niche-focused on improving the drug and device development continuum, ICON has developed an array of integrated technologies such as ICONIK, MIRA, NONMEM, and more to drive transparency and accelerate market access. This has won the company numerous accolades, including the ‘Pharma Contract Services Company of the Year’ at the Pharma Industry Awards in 2018. With a global footprint in 37 countries, ICON plans to continue to upscale its operations and develop innovative solutions to boost its clients’ drug development efficiency and productivity in the future.

“ICON offers a range of consulting, standalone, or full-service integrated solutions that are geared toward our client’s successful project completion



Dr. Steel Cutler


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