Lifesciences
Driven by the need to address critical issues within a rapidly growing sector, the life sciences industry is focused on leveraging its IT systems to significantly improve and expand its resources. CSTI is a recognized national leader in IT and regulatory compliance services providing a broad range of consulting and management services to pharmaceutical, biotech and medical device manufacturers. The unique combination of our IT, Regulatory, and Engineering Practices brings an unparalleled breadth of knowledge and experience to our clients.
CSTI maintains a dedicated Life Sciences Practice that consistently reevaluates the market to determine areas of improvement. Our practice leaders constantly challenge ourselves to bring “true savings” whether through cost reduction or by reducing a products time to market.
Our offerings include solutions that transform a client’s business and IT processes through improved governance & compliance, technology utilization and integration, and working with partners to bring the latest in technology and business practices to bear on a problem. Some of our areas of expertise are In the following areas:
- Clinical Research and Development
- Data Management
- Bio-statistics and Programming
- Mechanical Engineering
- Scientific Research
- Drug Safety and Pharmacovigilance
- Quality Assurance
- Regulatory Assurance
Our clients benefit from:
- Knowledgeable and team-oriented project managers and analysts
- An ability to approach virtually any technology with expert personnel
- A “brain trust” type of environment that can assist with almost any question in the realm of computer validation, Part 11, and computer system testing
- A customized approach to meet individual client requirements
- Clear, well-organized, and defensible SOPs, validation reports, testing reports and other documentation to meet the most stringent regulatory requirements
