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 the following programming services for all clinical trial phases and therapeutic areas:

• Analysis Dataset Programming and Documentation
• Tables, Listings and Figures Programming
• Tables, Listings and Figures Validation and Quality Control
• Interim patient tracking reports
• Patient Profiles
• ISS/ISE Preparation
• CDISC Study Data Tabulation Model (SDTM) Mapping & Conversion
• CRT package (SDTM datasets with annotated CRF’s and ‘define.xml’)
• Calculation of Pharmacokinetic Parameters

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 specific clinical trial plans.  We deliver quality, flexibility, and the responsiveness of a streamlined organization.

Provonix offers to their clients:

• Protocol Review & Development
• Phase I-IV Study Design Consultation
• Sample Size and Power Calculation
• Randomization Schedules & Implementation
• Adaptive Trials
• ISS/ISE Preparation
• Statistical Analysis Plan
• Clinical Study Report Writing
• IDMC/DSMB support
• Statistical Representative at FDA Pre- and Post-Submission Meetings

Provonix provides many data management services:

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  Our preferred EDC software platform is Medrio.

Medrio provides eClinical software that is configured through a web-browser without any programming.  

Advantages of using Medrio are:

• Faster deployment
• Low Cost
• Easy to Use

We will work with other EDC platforms, depending on client preferences.

Our highly experienced medical writers seek to provide each client with well-written, high-quality documents that conform to ICH and GCP guidelines.

Specific Documents that Provonix Medical Writers provide are:

• Clinical Protocols
• Study reference manuals
• Clinical Study Reports (CSR’s)
• Informed Consent Documents
• Clinical Trial Registry documents
• Regulatory briefing documents
• Case Report Forms
• Investigator Brochures (IB’s)
• Investigational New Drug Applications
• New Drug Applications
• Abbreviated New Drug Applications
• ISS/ISE
• Standard Operating Procedures
• Abstracts and manuscripts 

Our highly trained Pharmacokineticists are some of the most recognized in the pharmaceutical industry.  They work with each client to ensure that the sampling and analysis strategy is optimized in order to maximize the amount of valuable information that can be obtained from each study.  

An example of the studies that we have supported are:

• Bioavailability/bioequivalence.
• 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.