SOURCE: IT & E International

October 16, 2007 16:18 ET

IT&E, Inc. Expands Compliance, Validation and Clinical Support Staffing Services to Meet FDA's Aggressive Drug Safety Monitoring

POTTSTOWN, PA--(Marketwire - October 16, 2007) - "As the U.S. Food and Drug Administration (FDA) rolls out new drug safety initiatives, pharmaceutical manufacturers need to quickly and thoroughly become compliant," said Harvey Greenawalt, pharmaceutical industry veteran and new President and CEO of ITE, Inc. IT&E was until very recently known as IT&E International, a division of Averion International (http://www.iteinternational.com). The new IT&E is located at 1610 Medical Drive, Suite 210, Pottstown, PA 19464; telephone 610-340-2002.

According to the official FDA website, "... the Food and Drug Administration announced a series of steps designed to strengthen and improve the management of drug safety issues. Over the last two years the Agency has led an aggressive effort to improve the management of important drug safety issues. Safety has been, and continues to be, a central focus of our regulatory work. This effort is of vital importance to the health of the Unites States public and to the mission of FDA."

"Major pharmaceutical manufacturers, already under significant marketplace pressure to release FDA-approved drugs, need clinical support, compliance and validation services that accelerate their efforts," Mr. Greenawalt continued.

"As a completely independent staffing services organization, IT&E provides leading pharmaceutical, biopharmaceutical and medical device companies with expertise in the areas of FDA Regulatory Compliance, Computer Systems Validation, Commissioning and Qualification, Supplier Auditing, Biometrics, Clinical Trial Monitoring and Project Management, Data Management, Pharmacovigilance and Regulatory Affairs throughout the clinical trials lifecycle," he said.

Combination of Sophisticated, Proprietary CRM dB Software and Hands-On Industry Experience Matches Professional IT&E Consultant to Exact Project Specifications

Mr. Greenawalt added, "IT&E with its talented team of industry veterans comprising many years of pharmaceutical, biopharmaceutical and medical device experience, utilizes the latest tools and procedures to help its clients move quickly and effectively through the FDA approval process. Our proprietary, proven CRM dB software system, coupled with ongoing relationships with the industry's most qualified, capable and available experts delivers the perfect consultant to every client."

About IT&E, Inc.

IT&E works to find the right solution for immediate client needs in the areas of Compliance, Validation and Clinical Support. IT&E has over 125 professionals in the field and an extensive proprietary database of thousands of pre-qualified consultants. IT&E has been servicing the pharmaceutical, biotech and medical device companies for over 12 years. The company is considered a Preferred Vendor and maintains Master Services Agreements with many of the top 50 pharmaceutical companies worldwide.

Contact Information

  • For further information contact:
    Phil Clark
    Executive Vice president
    IT&E International
    610-340-2002
    Email Contact
    or
    Steven Swartz
    SIZZLE PR
    978-524-9595
    Email Contact