Welcome to Z-estima

Quality, Responsiveness, Integrity & Flexibility

Collaborating with Start-ups & Small Groups

Support in the Design of Clinical Trials & Management of Third Party Vendors

Working with Pharmaceuticals & Biotechs

Preparation of ISE/ISS, Active Input in FDA & EMA Regulatory Submissions

About

During my 20 years working as a biostatistician, I collaborated with pharmaceutical and biotech companies, as well as CROs, in Europe, the US and Asia.

I have been helping companies with the preparation of regulatory submissions (ISE/ISS), including interactions with the FDA, MHRA and EMA. My core experience is in vaccines, ophthalmology and rare diseases.

In recent years, I have mainly collaborated with start-ups and small groups, which I particularly enjoy. I’ve been supporting them in the design of their clinical trials and in the management of their providers for the generation of tables and listings, with guidance on CDISC formats. I also served as an unblinded statistician for DMCs/DSMBs.

I have worked and lived in many countries throughout the World during my career. I am fluent in English, while French is my mother tongue.

Services

Patients Data are the Raw Material. Well-thought Collection, Analysis & Integration are the Core of our Business.

Prior Data Collection

Clinical Study Design
Sample Size Calculation
Protocol Review & Statistical Section Writing
Randomisation
CRF Review
Statistical Analysis Plan

During Data Collection

Data Analysis & Reporting

Post Reporting

Therapeutic Area

I have 20 years experience within the Industry. During the past 10 years, I have gained knowledge in ophthalmology, with insight in imaging assessments, as well as visual acuity reporting.

More recently, I have been involved in clinical trials for rare disease whilst my early years were focused on vaccines.

Appreciation

Thanks E. You made my life so much easier--I did not have any worries for the stat part, you took care of everything!

Many thanks for providing the update and for the strong support you provide for our programs

I really appreciate the clarity that you are bringing to these analyses!”