Statistics

Statistical
Programming

Provonix is a contract research organization that provides innovative statistical, programming, and data analysis solutions to meet the complex needs of pharmaceutical, biotechnology, and medical device companies.

Statistics

Our staff of Ph.D. and M.S. level statisticians becomes part of the client's team. We engage with the client's staff in discussion of study design and analysis strategy. Our analysis team seeks the optimal approach to your specfic clinical trial plans. We deliver quality, flexibility, and the responsiveness of a streamlined organization.

Protocol Review & Development; Sample Size & Power Calculation; Statistical Analysis Plan; Randomization Schedules

ISS/ISE Preparation; IDMC/DSMB Support; Clincial Study Report Writing; Adaptive Trials

Statistical Programming

The goal of our programming staff is to ensure that each table, listing, and figure created is accurate and clear, and adheres to ICH E3 guidelines. We can program TLF's based on client-specific templates or our own ICH E3 compliant templates. Provonix offers programming services for all clinical trial phases and therapeutic areas.

Tables, Listings & Figures; TLF Validation & Quality Control; Interim Patient Tracking Reports; Analysis Dataset Programming

ISS/ISE Preparation; CDISC Mapping & Conversion; CRT Package (SDTM Datasets); Calculation of PK Parameters

Although our core services are biostatistics and statistical programming, Provonix has developed partnerships to offer seamless solutions for the following services:

Data Management

Pharmacokinetics

Medical Writing

Experience

80

Provonix has provided support
to over 80 studies

20

in more than 20
therapeutic areas

3

in all 3 phases of drug development.

Since 2008, Provonix has provided statistical consulting and statistcal programming support to Phases I, II and III of drug development.

We have supported many therapeutic areas. The majority of our studies are oncology.

Jeff Botbyl, CEO

Provonix is a customer-focused contract research organization specializing in Statistical Consulting and Statistical Programming services. Through our strategic partners we also provide support in all data-related and reporting aspects of clinical trials, including Data Management, Medical Writing and Pharmacokinetics.

Founded in 2008 by Jeff Botbyl, Provonix is a small, dedicated group of highly experienced professionals with an unmatched dedication and responsiveness to our clients. We have a shared goal in developing products that will help people lead better, healthier lives.

Management

As CEO of Provonix, Jeff is responsible for leading the company's global operations and setting the company's mission and vision. Jeff oversees the growth, development, and management of the staff, sets the company's expectations and goals, and serves as a statistical consultant to our clients.

Prior to starting Provonix, Jeff held senior level statistical and management level positions at the University of Pennsylvania, GlaxoSmithKline, and ICON. Jeff received a Bachelor of Science Degree in Statistics from the University of South Carolina and a Master's of Science Degree in Biostatistics from the University of Pennsylvania.