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GxP compliant clinical trial analysis and reporting

GxP compliant clinical trial analysis and reporting entimICE FastTrack in use Book a demo Your profile You are working with a pharma or biotech company with an active phase II/phase III clinical trial pipeline. Your clinical data science ecosystem is overly complex or outdated, in the worst case both. Your daily business processes are disconnected and inefficient and your clinical trial teams blocked by the inability to use the best tools for the tasks at hand. Your challenge ...

Enabling open source for regulatory activities

Enabling open source for regulatory activities entimICE FastTrack in use Book a demo Your profile You are working for a biotech or pharma company with an active Phase III clinical trial pipeline, or for a CRO providing biometrics services to sponsors. Your teams are engaged to make use of R in clinical trial reporting activities, in combination with SAS or as a replacement for SAS. Your challenge The use of open-source technologies such as R and Python in clinical R&D has been growing steadily for years,...

Enabling open source for non-regulatory activities

Enabling open source for non-regulatory activities entimICE FastTrack in use Book a demo Your profile You are working with a pharma or biotech company with active real-world evidence projects. Your company has an established Phase II/Phase III clinical trial pipeline, and you are looking to smooth the transition between real-world research and clinical trial research. Your challenge Open-source technologies such as R and Python have long been used in real-world research. As their...

Multi-sponsor management for CROs

Multi-sponsor management for CROs entimICE FastTrack in use Book a demo Your profile Data management and biometrics teams involved in clinical trials across multiple sponsors often work with a mix of systems—some provided by the sponsor, others based on their own internal setups. Each sponsor typically enforces their own SOPs, requiring your CRO to adapt its processes and tools to meet different expectations. This requires a high level of flexibility from CRO teams to ensure compliance...

Collaboration with CROs

Collaboration with CROs entimICE FastTrack in use Book a demo Your profile You are working for a small-to-midsized biopharma (SMB) or a biosimilars generics pharma company with a few clinical trials. Your company is outsourcing most activities to CROs, and your small biometrics team manages many deliveries from multiple different CROs simultaneously.  Your challenge SMB biopharma and biosimilars generics pharma companies often fully outsource the management of clinical trials to...