The acquisition helps ISI strengthen its capabilities to offer clients a mix of process, technology, data and operational services in a complex regulatory submission environment. ISI’s professional services business already saw a 26% increase in sales from 2007 to 2008.
“This addition to ISI enhances our flexible and holistic suite of services and software to the regulatory space,” said Jinsoo Kim, president and CEO of ISI. “Industry leadership and experience from Apyx helps fuel our mission of helping bring life-changing therapies to market safely and efficiently.”
ISI currently provides 13 out of the top 20 pharmaceutical companies with ongoing services. In the last decade, the company has helped biopharmaceutical companies bring dozens of therapies through regulatory approval. Founded in 1992, ISI provides submissions solutions, process services and consulting to life sciences companies as a way to improve clinical and regulatory processes. ISI was among the first professional services firms to deliver electronic submissions to the industry.
The company said its strategic focus is on submissions, but it also offers clinical data management services, such as annotation of case report forms, manipulation of SAS data, and integration of multiple data formats. In addition, ISI provides statistical analysis, data set review and statistical writing services.
ISI has 455 employees in the U.S., Europe, China, and Korea, and Apyx adds 20 employees.
ISI makes the Apyx acquisition at a time of regulatory uncertainty for the pharmaceutical industry. Changing regulatory standards across regions, the need to expand into emerging markets, and increasing pressure to collaborate with partners and oversee local operations are all contributing to the new era of complexity.
“We are joining forces with ISI because there is a huge opportunity to leverage each other’s strengths,” said Ken VanLuvanee, CEO, president and founder of Apyx. “With ISI’s deep resources and expertise in Europe and Asia, we will be able to address the diverse range of submission requirements across the globe.”
VanLuvanee becomes ISI’s vice president of Global Professional Services, reporting to Paul Chung, executive vice president. VanLuvanee will be leading the effort to further expand ISI’s professional services capabilities, using his prior experiences within the consulting business around document management, business process improvement, Clinical Data Interchange Standards Consortium (CDISC) submission services and program management. He will continue to be an active contributor at various industry forums and various standards’ development initiatives.
ISI is a CDISC-registered solutions provider. ISI encourages sponsor organizations to embrace the standards as early as possible in the process, providing implementation and validation services along the way, such as supporting electronic data capture for clinical trials directly under newer data content standards.