ICON
Bringing Better Medications to Patients around the World

With a mission to help clients accelerate the development of drugs and devices to save lives and improve the quality of life, ICON was established in Dublin, Ireland in 1990. Delivering best in class information, performance and solutions with an unyielding focus on quality, ICON offers a range of consulting, development and commercialization services from offices across 37 countries. Focusing on innovative factors that are significant to clients— reducing costs, increasing quality, and reducing market time—the firm has grown organically, as well as bolstered growth through numerous strategic acquisitions, broadening its service portfolio.

"ICON understands the challenges of researching in the region and utilizes its countryspecific knowledge to deliver quality data to its clients on time and within a budget"

As a CRO in the Asia-Pacific region, local know-how is its specialty. ICON understands the challenges of researching in the region and utilizes its country-specific knowledge to deliver quality data to its clients on time and within a budget. Numerous factors contribute to the Asia-Pacific being the appropriate location for clinical trials. Some of them include regulatory bodies encouraging multi-regional trials, patient access, constant improvement of quality and standards. The firm has the ability and expertise to conduct clinical trials and development projects locally, cross-regionally and globally, and provide a full range of its services. “ICON recognizes the challenges customers are facing and is focused on building our integrated site and patient network to improve trial start-up, as well as patient recruitment and retention,” says Dr. Steve Cutler, CEO of ICON.

Specialized Services

Utilizing its innovation and insight, ICON drives measurable performance improvements. Its operational capabilities and therapeutic expertise ensure it delivers value and operational excellence in the development of drugs. It offers an array of specialized services to assist biotechnology, pharmaceutical, and medical device companies to introduce new devices and drugs in the market faster. The company offers knowledge, software, systems and a global footprint—making global adaptive trials a reality. Adaptive designs have witnessed a rapid rise due to their ability to increase portfolio valuation by drug protection and enhanced decision-making. With over 15 years of experience in planning and managing adaptive clinical trials successfully, ICON is “the only CRO to offer validated design, simulation and analysis software platform for adaptive clinical trials.” The firm also offers a fully integrated approach and cost-effective solutions for the development of biosimilar medicines.

Recognizing the importance of decision making and strategic analysis in drug and device development, ICON provides guidance across regulatory planning and development for all sections of MAAs, NDAs and more

With biosimilar medicines promising an attractive offering to healthcare organizations, patients and physicians, ICON helps choose the correct molecule, the optimal development, and commercial strategy. From selecting the target biologic, characterizing the structure, processing scale-up and functioning of the molecule, specialist consultants are there at every stage. Besides, commercialization and outcomes of the firm deliver resources and expertise to classify, generate, amalgamate, and communicate evidence of safety, and treatment value. This is done to help payers, providers, regulators, and patients make informed health decisions, thereby, improving the quality of life through innovative treatments.

Recognizing the importance of decision making and strategic analysis in drug and device development, ICON provides guidance across regulatory planning and development for all sections of MAAs, NDAs and more. It assists in preclinical and non-clinical development, chemistry, manufacturing, controls, and so forth. It also serves U.S. Federal and NGO clients. Its Government and Public Health Solutions (GPHS) offers a full staffing service and clinical development across numerous agencies in the U.S. Government. The clinical development extends across basic and applied research, infectious and neglected tropical diseases, vaccines, testing, bio-threats and more.

Moreover, understanding the unique requirements of medical devices and diagnostics, ICON provides tactical solutions, strategic support, and software devices. The firm’s medical team guides clients with new product development and enhancements, offering consultancy services and support throughout the product life cycle. The services provided by the firm span the entire product development lifecycle and are best suited for, both, small local trials and large global programs.

The Therapeutic Areas

ICON’s team of experts has hands-on experience in a broad range of therapeutic areas. In line with patient care, the firm has begun transforming drug development and conducting clinical research in solid and haematological tumours— including gastric, lungs, leukemia, breast, prostate and more. Moreover, with CNS (Central Nervous System) drug development norms reaching the highest failure rates across most therapeutic areas, ICON’s innovative protocol design, site training, and real-time data quality analysis minimizes risks and maximizes the probability of success.

With new and re-emerging diseases on the rise, the firm also supports and helps navigate the path of developing approved treatments and vaccines within a budget. With highly experienced Clinical Enrolment Managers, ICON offers a customized recruitment strategy for, both, study and execution of the plan. The team also ensures it is supported in building a roster of patients before recruitment, reducing timelines and providing pre-screening transparency. The firm also has extensive experience in cardiovascular clinical research trials, endocrine and metabolic disorders, gastrointestinal studies, non-alcoholic Steatohepatitis clinical trials, ophthalmology and more. ICON works across the entire drug and device development spectrum.

Transforming Trials

With traditional clinical development requiring change, ICON designs models to meet the requirements for therapies that target huge patient populations. As the existing models lack flexibility and analytical power, the firm manages product pipelines and addresses the patient’s role in care decisions. ICON improves Pharma R&D efficiency that provides insight into clinical research and solutions. It also leverages and monitors wearable devices and sensors in clinical trials. This is an initiative to improve the process of quality—confronting fundamental risks, disrupting inefficient processes, leveraging mobile technologies and more.

Innovation at ICON

Focusing on factors that are crucial for clients, ICON develops integrated technologies to improve the efficiency and productivity of drugs and device development programs. This helps provide transparency across all the areas of research and study. Some of the technologies invented include the ICONIK, ADDPLAN^®, MIRA, and NONMEM^®. While ICONIK analyzes clinical, operational and real-world data to improve protocol designs and develop models scenario, ADDPLAN^® covers study designs for all clinical development phases. With the healthcare delivery model shifting its focus on the value of treatment rather than fee-for-service, medical device and drug developers are taking a more integrated approach to build their products’ regulatory and reimbursement strategies. For instance, MIRA helps collect, manage and process data to improve quality and reduce time in imaging management and NONMEM^®, analysis programs that are used to fit models to numerous types of data.

Apart from its innovative technologies, the ‘quality of work’ has been essential in the success of ICON. Since its inception, the firm has been committed to supporting, improving, maintaining and checking its quality systems to exceed the standards demanded by patients and clients. Identifying and addressing the unmet needs of clients, ICON has gone on to win ‘Pharma Contract Services Company of the Year’ at the Pharma Industry Awards in 2018. “We are thrilled to be honored as the industry’s best contract services company and are delighted that our employees’ hard work and dedication is being recognized,” concludes Cutler.