Sanjay Patel, VP & Global Head of Data ManagementToday, the medical industry recognizes clinical data as the core asset of health and medical research. However, the necessities to strictly maintain Clinical Data Management (CDN) standards that fulfills regulatory requirement are making clinical studies more complex. At the same time, multiple clinical data sources and the lack of standard data management tool leads to scattering of trial data, creating difficulty for the users to access insightful data in real-time. Integrating these unstructured data for seamless delivery and access, ICON [NASDAQ:ICLR]—an outsourced pharmaceutical, biotechnology, and medical device development services provider—effectively runs clinical trials for pharmaceutical companies. The company’s robust integrated data management solutions deliver customers single access to numerous systems through a portal.
This integrated data management solution is helping to deliver clinical data in a standardized way; irrespective of who the consumer is. It encompasses a single data set to perform multiple actions that support the evolving need of data insights, such as study design, execution, and data analysis. ICON is providing cloud based services like e-PRO (electronic Patient Report and Outcome), where patients and physicians can access medical reports from their mobile devices. “With the help of cloud based solution ePRO, healthcare organizations could eliminate the hassle for accessing patient record data in papers and risk of losing them,” says Sanjay Patel, VP and Global Head of Data Management, ICON. The company facilitates development and review of clinical case reports and creates design for case report format (CRF). “We emphasize on applying SDTM standard in CRF design, which is critical in collecting patient data in the right format,” says Patel. “It ultimately ensures that the clinical data is relevant and regulatory submission compliant,” he adds. ICON delivers comprehensive documentation quality edits and clean delivery of data files ensuring data integrity which is important to the success of clinical case studies.
ICON has developed their standard operating procedures to deliver high quality data and services to the clinical researchers.
Having a global footprint in the CDM domain, ICON has simplified the data management system of numerous healthcare centers. One of their customers with large oncology portfolio required to collect and integrate long time safety survival data of their patients. The client encountered great difficulty as they had to put their clinical study on hold for collecting the entire data. It was expensive as they required hosting the study on cloud till the data integration is completed. So, ICON helped the client by designing a single database to integrate the patient safety survival data from several different studies. It helped the customer to save significant amount of money and time because they no longer needed to host multiple studies for long.
We emphasize on applying SDTM standard in CRF design which is critical in collecting patient data in the right format
ICON is significantly investing in innovation and development of new technologies to deliver disruptive solutions and products. Being a wildlife enthusiast, Patel applies the nature’s rule of interdependency in ICON. He has developed a culture of supporting the development of original ideas and concept. “Our interdependency culture has enabled us to better deliver high quality clinical data management solution to our customers,” shares Patel.
Over the years, ICON is leveraging their data strategy to add more value in the CDM domain. Being a company with business spread across the world, ICON has presence in all key market areas. In the near future, the company will enhance their services and operations so that they can deliver more cost efficient and high quality data to their customers.