Machine learning tools are relatively new across any industry. Implementing a regulated R&D analytics tools with machine learning can be especially challenging with many unknowns
A rapidly growing medical device company’s project teams were overworked. Employees were falling further and further behind with each subsequent project approved by their leadership. The client knew there was a problem. But how to solve it?
Our pharmaceutical client needed a technically-focused project manager who understood their diagnostic business fundamentals, but also had the experience to drive towards deadlines and achieve milestones.
A Top 25 pharmaceutical company approached us with a common problem. We have seen this problem for years throughout the industry.
Based on regulatory guidances and TransCelerate approaches, a client wanted to change multiple monitoring processes. Additionally, the client wanted to incorporate central monitoring analytics.
An east coast based midsized pharmaceutical client required immediate data management services to take over EDC build and the creation of data transfer specifications for 10 third party vendors
The client had little NDA filing experience and needed an experienced team to develop a filing strategy, complete programming and statistical analysis, and author CTD and other documents.
Recognizing the challenges of moving into GMP manufacturing, the client requested GMP project management support for the transition from the previous facilities services partner to the client’s services management.