Navigation Links
ISI Bolsters Data Analytics Capabilities for Complete Suite of Submissions Outsourcing Services
Date:11/13/2007

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.

Press Contacts:

Lisa Meyer Matt Hantz

Director, Global Marketing M Booth & Associates

973-560-0808 x. 217 212-481-7000

lisa.meyer@imagesolutions.com matth@mbooth.com


'/>"/>
SOURCE Image Solutions, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Aria Analytics Receives JumpStart Investment
2. Wachovia Strengthens Its Healthcare Industry Receivables and Cash Management Capabilities
3. HMS Acquires Permedion to Expand Clinical Review Capabilities
4. Stereotaxis Showcases Interventional Cardiology Capabilities of Niobe Magnetic Navigation System
5. Thermo Fisher Scientific Expands Clinical Trial Services Capabilities with New Facility in India
6. Natural Nutrition Expands Revenue Capabilities with Newly Installed State of the Art Nutrition Bar Line
7. Corrected & Replaced - Natural Nutrition Expands Revenue Capabilities with Newly Installed State of the Art Nutrition Bar Line
8. Hurley Medical Center Enhances Customer Service Capabilities With Beryl Partnership
9. Eligard(R) six-month formulation successfully completes European approval procedure
10. The ScottCare Corporation Completes Acquisition of Rozinn Electronics, a Leading Manufacturer of Cardiac Diagnostic Products
11. EaglePicher Corporation Completes Transaction to Sell EaglePicher Boron, LLC to Ceradyne, Inc. for $69 Million
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ... ... a crisis. Her son James, eight, was out of control. Prone to extreme mood shifts ... upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife ... and say he was going to kill them. If we were driving on the ...
(Date:6/24/2016)... ... 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that 20 ... by their peers for this recognition are considered among the top 2 percent of ... honors as members of this year’s Legal Elite Hall of Fame: Miami Shareholders ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Comfort Keepers® ... American Cancer Society and the Road To Recovery® program to drive cancer patients to ... and other adults to ensure the highest quality of life and ongoing independence. ...
(Date:6/24/2016)... ... 2016 , ... People across the U.S. are sharpening their pencils and honing ... contest in which patients and their families pay tribute to a genetic counselor by ... Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In ...
(Date:6/24/2016)... ... 24, 2016 , ... The Haute Beauty Network, affiliated with ... as a prominent plastic surgeon and the network’s newest partner. , Dr. ... handsome men, look naturally attractive. Plastic surgery should be invisible.” He stands by ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... FRANCISCO, Calif. , June 24, 2016 /PRNewswire/ ... ), a biopharmaceutical company developing novel therapeutics for ... unmet needs, today announced the closing of its ... of common stock, at the public offering price ... in the offering were offered by GBT. GBT ...
(Date:6/24/2016)... , June 24, 2016 The Academy of ... recommendations that would allow biopharmaceutical companies to ... entities that make formulary and coverage decisions, a move ... of new medicines. The recommendations address restrictions ... appear on the drug label, a prohibition that hinders ...
(Date:6/24/2016)... -- According to a new market research ... Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, 8mm, ... Purchase (Retail, Non-Retail) - Trends & Global Forecasts to ... for the forecast period of 2016 to 2021. This ... 2021 from USD 1.65 Billion in 2016, growing at ...
Breaking Medicine Technology: