Quality Driven. Statistics & Programming Focused.
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.
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.
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.
Although our core services are biostatistics and statistical programming, Provonix has developed partnerships to offer seamless solutions for the following services:
Provonix has provided support
to over 80 studies
in more than 20
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.
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.
News & Events
Our partnership data management services include:
- Electronic Data Capture (EDC)
- Online Access & Reporting
- Data Quality Plan
- CRF Design/Review
- CRF Annotation
- Edit Check Programming
- Quality Control
- Logging and Tracking of Individual CRFs
- Independent Dual Data Entry with Reconciliation
- Discrepancy Resolution
- Data Reconciliation
- Medical History Coding
- Adverse Event Coding
- Medications Coding - WHO Drug
- MedDRA Coding of SAEs
- SAE Management
- SAE Reports - Direct Upload to MedWatch and CIOMS
- Data Listings
- Data Import and Export
- Data Storage, Back-up, Archival
- Remote Accessibility to SEA Database Via the Web
Our partnership pharmacokinetics services include:
- First Time in Human
- Single Ascending Dose
- Multiple Ascending Dose
- Drug-Drug Interaction
- Food Interaction
- Hepatic/Renal Impairment
- Age/Gender Effect
- Formulation Development
- Thorough QTC
- PK/PD Modeling
- Population Pharmacokinetics
Our partnership medical writing services include:
- Clinical Protocols
- Study Reference Manuals
- Clinical Study Reports (CSR)
- Informed Consent Documents
- Clinical Trial Registry Documents
- Regulatory Briefing Documents
- Case Report Forms
- Investigator Brochures (IB)
- Investigational New Drug Application
- New Drug Application
- Abbreviated New Drug Applications
- Standard Operating Procedures
- Abstracts and Manuscripts
We are not currently looking for additional team members. Please check back later.