Helping Your Company Be Succesful
Biostatistics and Data Management consulting across all stages of your company's evolution
Helping Your Company Be Succesful
Biostatistics and Data Management consulting across all stages of your company's evolution
About Independent Biostatistics Consulting
Our services cover the full lifecycle for drugs and device development, addressing the unique needs of your company at its different stages
Early Stage/Phase 1 Companies
As your company may not yet have an established pipeline, it is likely you cannot justify having a full-time biostatistician as part of your staff.
Based on our experience we can help you define the roadmap and requirements for product approval with a focus on high quality deliverables and shorter time to market. Many times, small companies rely mainly on contracting companies, which tend to execute on task basis and do not focus on guiding the company to the big picture.
Growing Companies
Your company may have a pipeline with a few products which are now past Phase 1. You are ready to scale up and now need more in-depth biostastics and data management process, take on the overall responsibility for meeting the strategic aims of the company, implement process and procedures to maximize quality of deliverables while minimizing cost and setting the basis for growth.
In addition to providing these services, we can operate as your biostatistics and data management department for a period of time, while assisting your company in identifying full-time staffing needs, help build your department, train the team, and set the group to be independent and successful.
Established Companies
As your product pipeline matures, you will run into hard experimental design or analysis problems which require in-depth technical help in relation to analysis the data, we are ready to handle your special projects, including presenting and responding to the FDA for drug approval and correcting your trials based on FDA requirements.
Main Areas of Focus and Statistical Expertise
Oncology, devices, etc
Background and Expertise
Sonia Souza, PhD
With over 30 years of experience in the biotech space, my experience encompasses biotech, pharma, and medical device fields, having worked for small companies, as well as very large international companies. I have successful build Biometrics groups from scratch and managed outsourced biostatistics, SAS programmers, and data management groups, driving a culture of excellence and focus on results.
I lead the end-to-end biostatistics strategy for multiple pre-IDEs and INDs applications, and supported PMA, NDA, and multiple 510Ks filings, defining the strategy for meetings with regulatory agencies, including the FDA, EU, Canada, and Chinese FDA.
I have in-depth knowledge of biostatistics, experimental design, and SAS programming, which I bring to all my projects, to ensure high quality deliverables and timely execution.
My most commercially successful pharmaceutical products to date are Cialis daily dose, for erectile dysfunction, and RECOTHROM, to aid hemostasis during surgery. I was responsible for the statistical design and analysis of clinical trials in support of three 510Ks, a PMA, and the Andexxa BLA submission.