Clinical studies include a plethora of details, and strong communication and transparency are essential for the optimum management of timelines and costs. The project managers are aligned into a specific therapeutic business unit based on their therapeutic experience, ensuring consistency through TFS SOPs and processes. The aligned project directors and directors of project management in each therapeutic business unit add another layer of quality control and oversight for the delivery of each undertaking. Finally, our project management team works with all cross-functional teams on each project as one integrated team.
TFS project management capabilities include expert data collection, compliance, and project tracking.
In practice, this means SOPs ensure that the implementation, validation, and maintenance of the systems used are compliant with all relevant regulatory requirements (including, but not limited to, ICH, GCP, and FDA 21 CFR Part 11).
Our system provides key validation documents, and our customers get access to a dedicated portal with all agreed data available 24/7, so that study progress can be followed anytime and anywhere, and specific study metrics can be tracked and monitored.