This customer’s mission is to enhance and extend lives through the development of superior health care products for a wide range of cancers, infectious diseases and autoimmune disorders. Their products include investigational personalized cancer vaccines and one of the worlds most widely studied immune adjuvant.

Challenges
It takes on average $600 to $800 million and eight to ten years for a drug to come to market, and much of that time and money is absorbed by clinical trials. The traditional, paper-based system used for recording, compiling and processing clinical trial data is unable to support the growing volume of information required of today's clinical trials. CTE was able to immediately identify how computer technology could make this large Pharmaceutical enterprise’s R & D processes more efficient.

Solution
To ensure public health, federal regulations require all manufacturers to maintain secure and auditable trails of information pertaining to every phase of the development and manufacturing process. Built into the Oracle E-Business Suite is a framework that complies with the FDA’s 21 CFR Part 11 and cGMP regulations governing electronic records and e-signatures. CTE implemented Oracle Process Manufacturing and assisted with the FDA validation of the Oracle System.

Benefits
	More efficient R & D process
	Reduced time to market