| Life Sciences | |
| General | |
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Strategic Consulting |
| Enterprise | |
| Quality & Auditing | |
| Clinical | |
| GSP Bio |
It is essential to base IT compliance processes and decisions on a stable foundation of industry acceptable standards and a rational risk-based approach. Our consultants work with your IT, quality, and business leaders to develop a customized risk-based approach which reflects both your business and compliance goals. Various suitable standards are brought forward and combined with this risk-based approach, to enable the development of a comprehensive approach for our client’s IT quality management. We assist our clients in determining the optimal sequence for implementing their IT Quality Management System that will support their short and long range business and compliance goals and objectives.
• A documented, baseline IT strategy
• IT portfolio management reports and methodology
• Criteria for assigning value to projects
• Establishment of a total cost of ownership
• Purchasing implementation sequence
• Computer system lifecycle
• Buy versus lease/host model
Information technology plays a key role in every aspect of the drug development lifecycle. Court Square’s understanding of FDA regulations enables us to employ the risk based approach necessary to help our clients plan for each important phase along the way.
Early stage companies often need to change their course to meet a new business or regulatory compliance need. IT organizations have to determine how best to maintain legacy applications define outsourcing needs and evaluate and implement new applications and technologies.
Court Square’s practice directors have an average of 17 years experience at pharmaceutical and biotech companies.
One-on-one planning development or assistance in the topic of your choice.
Working with both your IT and business leaders, our consultants develop an effective means of making IT investment decisions. We evaluate:
• Needs definition
• Total cost of ownership
• Implementation of structured project selection methodology
• Review of the Value/Risk continuum of purchasing/ building/ leasing/ outsourcing
We provide recommendations on a process for reviewing IT investments and review current investment decisions. Our process enables clients to make both short and long range decisions without the constant pull and push of daily firefighting.
