PRI has chosen its team members carefully. PRI prides itself on the combined experience of our team which enables the provision of a wide scope of services to our clients. Each member of the PRI team has substantial experience and has worked within industry, academia, and FDA. PRI team members have skills in multiple software packages and can tailor the analysis to meet your needs at a reasonable cost.
Our team analyzes your pharmacokinetic and pharmacodynamic data using noncompartmental or pharmacometric analysis and provides you with clear concise reports of the highest quality (used as the basis for the CHMP guidance document!) allowing you to facilitate faster, better informed decision-making during your drug development process and ensuring fewer queries during the regulatory review process. We tailor the report content to your specific needs.
BEFORE any work is undertaken PRI will provide you with:
A detailed description of individual tasks and durations
A detailed listing of costs for each task enabling you to tailor your requirements dependant on your budget and in-house capabilities
Team members who will conduct your analyses link to CVs
A detailed analysis plan (a sample can be provided upon request)
DURING the analysis PRI will provide you with:
Web based teleconferences to go over intermediate results and discuss findings
Ability to shift evaluations if the team needs alter during the evaluation
High level summary document for briefing books or CTD Section 2.7
AFTER the analyses are completed PRI will provide you with:
Clear concise reports which meet current regulatory requirements (a sample can be provided upon request)
A one-on-one meeting with PRI to discuss findings and results
An archive CD of all results