Therapeutic Expertise.
You set out to treat suffering, cure disease, and make the world a healthier place. Together, we’ll make that happen.
Who We Are
A combination of creative thinking and expertise
Innovative trial designs, combined with our regulatory expertise, allow us to optimize your trial for maximum impact in all phases of the Trial.
We are willing to take bold action to achieve the extraordinary.
Statistical Consulting
At the project level we can assist you in preparing a Clinical Development Plan. At the individual protocol level we can help you prepare a protocol by translating the objectives into testable hypotheses, and choosing the proper study design and analytical strategies. Our value proposition is not just in the statistical know-how, but in how we apply this knowledge in the context of regulatory expectations. We write the Statistical Analysis Plans (SAP) in great detail and well before the database-lock so that these expectations are met without issues.
Regulatory Interaction
We are happy to defend the design and the statistical methodology we suggest in the protocol and the SAP to the regulatory bodies. We have had experience in preparing briefing books, providing written responses to the agencies, and also numerous interactions with the agencies in face-to-face meetings.
Non-compartmental Analysis
Our pharmacokinetics uses WinNonlin to derive the pharmacokinetic parameters according to the methodology specified in the Pharmacokinetics plan or Statistical Analysis Plan (SAP)
Our Experience
Combined Team Analytics
90+
Projects Covered
100%
Success Rate
150+
Projects Complete
2000+
Studies Overall experience
OUR PARTNERS & PLATFORMS
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