We have unlocked enormous potential to develop and deploy the industry's lead regulatory submissions products and services through our rapidly expanding development facilities in China, Korea and India.
WHIPPANY, N.J. (PRWEB) March 5, 2008
"ISI's tremendous performance in 2007 is a result of our number one market share position in regulatory submissions for the life sciences industry," said Jinsoo Kim, president and chief executive officer of ISI. "2008 is expected to be another strong year as we tap underserved markets such as biotechnology and expand our footprint among top 50 pharmaceutical companies with additional services, such as regulatory consulting, CDISC services, and biometrics. As ISI grows, we are equally dedicated to reinforcing our infrastructure and delivering quality support to our customers. ISI plans to launch several initiatives with its clients in 2008 to ensure our highest levels of delivery."
One key infrastructure differentiator for ISI has been its Tianjin, China, location. It is one of four Centers of Excellence dedicated to supporting Case Report Form (CRF) processing and eSubmissions document processing. Over the last two years, ISI's Tianjin operation has processed 13 million CRFs and submission documents. Currently, the operation has monthly processing capacity of over 500,000 pages. As pharmaceutical companies look to focus internal resources on core functions like research and development, ISI's ability to efficiently process CRFs, the most labor-intensive portion of the clinical trials process, establishes the company as a key strategic partner to industry.
There are currently 121 employees in ISI's Tianjin office, which was ISI's first location to be granted ISO 9001:2000 certification by the International Organization for Standardization (ISO) for meeting quality standards in all areas of its operation.
Software & Services Growth
During 2007, ISI's marketshare for its flagship electronic publishing solution, eCTDXPress, grew from 27% of Top 50 pharma to 42%. Based on its strong industry penetration, ISI released a mid-market solution - the Compliance-in-a-Box (CiB) Submission Edition developed with EMC Corporation - a pre-packaged, integrated regulatory compliance solution that provides organizations the flexibility they need to submit in paper or electronically using the electronic Common Technical Document (eCTD) format. ISI also introduced a new tool, Virtual Link Manager, which maintains cross-document hyperlinks even when both the source and target documents have changed.
ISI also bolstered its clinical services in 2007 through the acquisition of Zurich Biostatistics, Inc. (ZBI), a leader in Clinical Data Interchange Standards Consortium (CDISC) standards and biometrics services. The addition of CDISC and biometrics services has enabled ISI to offer a complete, end-to-end submission outsourcing capability. Michael Palmer, ZBI President and now Vice President at ISI, had been instrumental in writing and maintaining CDISC's XML standard for clinical trial data, and has served on CDISC's Operational Data Model team since 2000. The acquisition added a team of highly qualified and experienced statisticians and programmers, which will help ISI clients speed new therapies through all phases of development.
Additional achievements in 2007 included:
-- Grew customer base from 120 global clients in 2006 to 150 clients in 2007
-- Received ISO 9001:2000 certification for the company's China operation
-- Expanded software development and testing capabilities, hiring additional developers in the United States and Asia
-- Employee expansion to 415 employees worldwide
-- Jinsoo Kim named a finalist for Ernst & Young's Entrepreneur of the Year (EOY) Award in New Jersey
-- Eighth nomination to the Deloitte & Touche New Jersey Technology Fast 50 list
-- Hit major milestones in outsourcing electronic submissions: more than 1,500 eSubmissions and 650 eCTDs (original submissions and sequences)
"ISI achieved record growth and profit in 2007 due to the strong support of our customers and our continued investment in people and technology," said Peter Kim, chief financial officer and vice president of finance for ISI. "We are on track in 2008 to achieve an eighth straight year of double-digit growth and plan to invest 10 percent of our revenue into research and development so ISI can remain on the cutting-edge of new innovations."
"ISI continued to be a strategic partner for clients by maintaining a strong record in electronic submissions in 2007," said Paul Chung, Executive Vice President of Global Software and Service Operations for ISI. "We have unlocked enormous potential to develop and deploy the industry's lead regulatory submissions products and services through our rapidly expanding development facilities in China, Korea and India."
ISI is also continuing to contribute 10 percent of net profit each year to charitable organizations like the United Way, Salvation Army, American Red Cross, UNICEF, Wishing Well Foundation, Habitat for Humanity, Compassion International, World Vision, Special Olympics - NJ, NJ Wheat Mission, Leukemia Society of America, Elizabeth Glaser Pediatric AIDS Foundation, Community Food Bank of New Jersey, Employment Horizons, Market Street Mission, Literacy Volunteers of Morris County and NJ Deaf Children's Association.
Tags: FDA compliance; eCTD; regulatory submission publishing; electronic submissions; drug development; drug development technology; pharmaceutical industry; biotechnology
Suggested Links: ISI Web site; FDA eCTD Guidance
About Image Solutions, Inc.
Founded in 1992, Image Solutions, Inc (ISI) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firms to deliver electronic submissions to the industry and since has delivered nearly 1,500 electronic submissions and more than 700 eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organizations as well as the top companies in other regulated industries.
ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to over 20 recognized charitable organizations. For more information, visit the company website at http://www.imagesolutions.com.
Image Solutions, Inc., ISIToolBox, eCTDXPress, ISIPublisher and ISIRegTracker are trademarks or registered trademarks of Image Solutions, Inc. which may be registered in the United States and internationally. Other brand names may be trademarks or registered trademarks of others.