Since 1997, Quantum Enterprises, Inc., has been actively engaged in consulting for specialty areas in R&D for the pharmaceutical & biotechnology industry with a good track record and corporate commitment. These areas include Content Management, meta-data and taxonomy management, Biostatistics/SAS basic and advanced training, Biostatistics analysis and services, Clinical research and training, Drug marketing studies, Regulatory submissions and publishing, CMC, Labeling, Clinical trial management and SAS programming/support.
QEs experienced core-team is headed by senior, Ph. D. level professionals with extensive experience related to NDA / PMA submissions and FDA interaction related to statistical issues. The company attempts to raise its standards, maturity and quality of service to the community by active learning from its on-site and field experiences. QE’s active Fortune 500 clients include Bristol-Myers Squibb, Sanofi-Aventis, Eli Lilly and Merck along with a sprinkling of mid-sized pharmaceuticals and CROs. We work with these organizations to realize the convergence of their business strategies and IT vision in an increasingly competitive and global business world.
The company’s approach to solving business and IT issues in the above paradigms is based on an objective analysis of a customer’s enterprise IT and business requirements. Working with our customers, we take the lead in augmenting expertise for required areas of development, support and follow-up. Be it, developing a submission and publishing system, conducting or supporting a clinical trial in phases I, II and III, SAS design and analysis, data/content management, validation, etc.
For the specialty areas mentioned above, QE has developed a number of re-usable software modules, components, libraries and prototypes. This was made possible by working closely with US customers from: Pharmaceutical industry, Research, Education, Hospitals; Healthcare professionals (Doctors, IS Administrators, Researchers, etc.), and their regulatory/compliance requirements. The company has also used this valuable experience to improve its existing processes and problem-solving methods for the specialty areas mentioned above. We build on our understanding of the challenges in a regulated pharmaceutical and biotechnology world - be it in solving complex healthcare integration problems or conceptualizing, developing, building and delivering new products and solutions.