"We have an End-of-Phase-2 meeting and we don't know what they'll push back on."
Regulatory Support: scientific rigor under pressure
We prepare you for the room. Briefing documents, meeting rehearsal, and live statistical support for FDA interactions, with EMA support where needed, from statisticians who have sat on both sides of the table.
Prepare for your meetingThe strongest possible scientific argument
Our support includes preparing briefing documents, writing questions, and providing support during critical meetings. We also guide clients on regulatory requirements, ensuring compliance and minimizing risks.
Our expertise is rooted in scientific rigor: every submission is built on sound statistical methodology and independent analysis. We make sure your data not only meets technical requirements but presents the strongest possible scientific argument for efficacy and safety, leveraging deep knowledge in specialized areas like neurodegenerative disease.
- Briefing document preparation
- Question strategy and drafting
- Live support during agency meetings
- Guidance on regulatory requirements and compliance risk
When the first pass hits an obstacle
Whether you face a partial clinical hold, an urgent FDA submission deadline, or preliminary data that requires a strategic pivot, Pentara specializes in study rescue and regulatory remediation. We apply independent statistical oversight to quickly diagnose underlying design flaws, statistical issues, or data deficiencies.
Our urgent response team prepares time-sensitive amendments, delivers rapid data analysis, and crafts the compelling documentation needed to get complex trials back on track and through the regulatory gates, crucial for salvaging significant financial investment and accelerating the delivery of critical therapies.
Partial clinical hold
Rapid diagnosis of the statistical and design issues behind the hold.
Urgent deadline
Time-sensitive amendments and rapid analysis turnaround.
Strategic pivot
Reassessment of outcomes and populations when early data disappoints.
Documentation
Compelling narrative built on defensible methodology.
Talk to the urgent response team →
Tell us what happened and when your deadline is.
Least expensive point to bring us in · Regulatory meeting
Briefing package and anticipated questions. Later, it is a question you can't answer on the day.
Walk into the meeting prepared
We'll help you anticipate the questions and answer them with the data you have.