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Critical systems at the critical phase

Are your existing systems supporting your clinical process out-of-date and cumbersome to use? Are you worried that your organization will be unable to readily meet regulatory reporting requirements? Depending on where you are in the development process, is there confusion about what technology to implement when?

The success of a drug development solution depends not only on choosing the right system at the right time, but also on ensuring that the solution is implemented and used accurately by the enterprise. A successful solution must adhere to and support regulatory requirements, such as the FDA's 21 CFR Part 11 standards on Electronic Records and Electronic Signatures. Adhering to these regulatory requirements is a focal point of internal and external oversight, where small errors can cost years and millions of dollars.

StratusG consultants have created successful drug development solutions for many clients. We have in depth knowledge and experience of the tools and processes involved in drug development and are experts at getting these systems right. We bring to the table over a decade of experience in life science process design, system selection, implementation, and support. Additionally, we understand the importance of the data, the business rules, and the processes that impact these systems.

Whether your organization is in the discovery and screening phase, or planning to launch into clinical trials, contact us to learn how we can help ensure your next success.

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