The Combination of IT&E and Clinical Trials Assistance Corp. Solidifies Leading Position in Life Science Services, Serving the Advance Clinical Research Studies and Regulatory Compliance Industry
IT&E International Group and Clinical Trials Assistance Corp., which announced that they were now one company, have changed the name of the combined companies to IT&E International Group and have been granted a new trading symbol, “ITER”. The joining of the two companies helps to solidify IT&E’s position as a biomedical services leader which has established itself as an innovator in the advance clinical research studies and regulatory compliance industry.
“The integration of Clinical Trials Assistance Corp. (CTAC) into IT&E is the first step in executing our strategy of building the premier life sciences services company, with a cost effective and time to market advantage for the pharmaceutical, biotech and medical device industries. We were already a quality leader in the FDA regulatory compliance arena, servicing many of the world’s largest pharmaceutical and biotech companies. The integration of CTAC is one further step in cementing IT&E’s Clinical Services & Solutions Division as the quality, cost and time to market leader. This and our future acquisition strategy will continue to make IT&E all the more valuable to our clients,” said Peter Sollenne, Chief Executive Officer of IT&E International Group.
IT&E provides services & solutions to the pharmaceutical, biotech and medical device industries through its two main divisions; the Regulatory Affairs Division; and the Clinical Services & Solutions Division. The Regulatory Affairs Division provides project-based consulting services to life science companies, providing to them the expertise to evaluate structure, implement and maintain effective quality programs and processes that ensure compliance with applicable FDA regulations. This division offers a diverse, all encompassing solution for the validation and compliance of quality systems, lab and manufacturing processes, clinical data systems, laboratory automation, content management, electronic document management, and a complete solution for facilities, utilities and equipment validation and compliance. The company, with its talented team of industry veterans with many years of biopharma experience, utilizes the latest tools and its own proprietary software to move quickly and effectively through the FDA and National Institute of Health (NIH) regulatory requirements. The Clinical Services and Solutions Division offers a full suite of clinical trial support services. The division’s services offerings include patient and investigator recruitment, biostatistical analysis, data management, data entry and verification and regulatory affairs services. In data management, the group provides case report form design, protocol development, data entry and verification, full tracking and audit trail documentation, adverse event reporting and electronic FDA submission. The Biostat Group provides data mining studies, data base design, representation at FDA and other regulatory meetings, and additional specialized biostatistical analysis.
“We know that the only way we can attract the type of marquee clients we do is to be the very best and consistently provide them with superior services. By the time our clients come to us for assistance, they have already invested tens of millions of dollars on research. They know that they can depend on IT&E to do everything possible to facilitate and speed them through the clinical trial process. Our singular focus on providing superior services is what has allowed us to grow with a focus on maintaining strong margins,” adds Sollenne.
IT&E’s pharmaceutical, biotech, healthcare and other life science client list includes such well-known companies and facilities as Eli Lilly, Pfizer, Bristol-Myers Squibb, Chiron, Schering-Plough, Amgen, Baxter, Wyeth, Aventis, Novartis, Medtronic, Allergan, Genentech, Biogen-IDEC, Purdue Pharmaceutical and St. Jude Children’s Research Hospital.
Included in this release are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations reflected in such forward-looking statements will prove to have been correct. The Company’s actual results could differ materially from those anticipated in the forward-looking statements.
