Biometrics and CDISC Conversion Services Provide Single-Vendor Support for
Electronic Common Technical Document Submissions
WHIPPANY, N.J., Nov. 13 /PRNewswire/ -- Image Solutions, Inc. (ISI), a leading provider of software and services to streamline the drug development and regulatory approval process, today announced it has expanded its outsourcing services to include a broader set of data analytics capabilities. ISI now offers a complete regulatory submissions solution compliant with the electronic Common Technical Document (eCTD) guidance.
ISI's biometrics capabilities, enhanced through the recent acquisition of Zurich Biostatistics, Inc. (ZBI), now include conversion of clinical trial study data into the U.S. Food and Drug Administration's (FDA) preferred format called the Study Data Tabulation Model (SDTM). The SDTM was developed by the Clinical Data Interchange Standards Consortium (CDISC) and is expected to lead to greater efficiencies in clinical research and FDA review of submissions.
"ISI differentiates itself with a 15-year track record of quality submissions and 100 percent FDA acceptance on completed submissions, one of the most critical factors in deciding the outsourcing question," said Michael Palmer, ISI's vice president of biometrics solutions and co-founder of ZBI. "In addition to this successful outsourcing performance, ISI also has a stable management team and a history of financial strength, which further reassures our client that we have a stable, mature organization to work with them."
The SDTM guideline comes as companies pursue outsourcing not only as a key strategy for meeting the January eCTD deadline, but also as a way to reduce costs and increase efficiency during the regulatory submission and approval process. ISI provides a range of business process services for companies that either seek to outsource completely or to blend internal capabilities with ISI skills and resources to overcome short-term resource constraints. ISI has been aggressively building its regulatory operations team and adding staff to its China operation, which officially opened earlier this year and now exceeds 100 staff members dedicated to processing Case Report Forms (CRFs) and future publishing support.
In the biometrics area, ISI now offers creation of statistical plans, statistical analyses, and preparation of clinical study reports. In addition, the ISI team offers expert statistical consulting for planning studies, communicating with regulatory agencies, preparing briefing documents, and attending agency meetings. In the area of regulatory submissions specifically, ISI offers analytical capabilities in support of integrated summaries of safety (ISS), efficacy (ISE), and submissions (NDA, BLA, etc.), as well as preparation of regulatory and CDISC-compliant electronic Case Report Tabulation (CRT) and analysis data.
Since the company was formed in 1992, ISI has aggressively moved to become an industry leader in providing flexible outsourcing solutions. ISI's complete outsourcing services include submission compilation, CRF processing, labeling conversion, and medical writing. To date, the company has managed some 550 eCTDs. The company's complete offering ensures that all submissions adhere to the regulatory guidelines for agencies around the world and protects against incomplete or incorrectly filed submissions.
ISI's biometric services and outsourcing capabilities, together with ISI's other best-in-class products and services, provide a seamless solution across all areas of the development and regulatory process. All of ISI's products are built on the Microsoft .NET Framework to allow for greater adaptability and flexibility in providing a single solution.
For companies wishing to learn more about the CDISC-developed format, access the company's webinar archive, Assessing Emerging Standards at http://www.imagesolutions.com/NewsEvents/AssessingStandards
About Image Solutions
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 1,200 electronic submissions and 500 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.
Lisa Meyer Matt Hantz
Director, Global Marketing M Booth & Associates
973-560-0808 x. 217 212-481-7000
|SOURCE Image Solutions, Inc.|
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