Are you having trouble hiring an experienced pharmacometrician/clinical pharmacologist to support your development programs?
Have you had a bad experience with a consultant who didn’t have the experience you needed, expected you to QC their work, or couldn’t meet your timelines?
Do you need advice from someone who has experience with multiple successful regulatory submissions and who can offer suggestions to prevent future challenges?
Cognigen’s staff of experienced consultants have been serving pharma & biotech companies big and small for almost 30 years. Our flexible business practices and agile consultants understand that things change rapidly, and we work to accommodate the ever-shifting needs of each program. We offer a variety of collaboration options and solutions to suit your company’s needs including:
Clinical pharmacology and pharmacometrics team members, who can support your program with quantitative support for decision-making and bolstering regulatory or development decision-making
An on-call backup team, ready to provide advice and suggestions on an ad hoc basis when things get complicated, or you simply need another perspective
A resolute team of clinical pharmacology and pharmacometrics experts, ready to take on everything from planning and study design, unblinded data review to expedite data processing and analysis-ready dataset creation, to modeling and simulation activities and interpretation of findings as well as comprehensive, regulatory submission-ready reporting
Extensive experience with regulatory agencies to assist you in formulating a strategy, help you prepare written responses, answer questions, and attend regulatory meetings in-person along with your team
A team that is well-versed in a variety of analytical techniques (NCA, population PK, PK/PD, exposure-response, PBPK, QSP, QST) and multiple tools, including Monolix®, PKAnalix™, Simulx™, NONMEM®, GastroPlus® and more
- A comprehensive Quality Management System and proprietary communication tools to share real-time detailed information regarding analysis progress and provide you with frequent and regular updates on project status.
Our consultants are committed to providing you with the highest level of service, meeting your timelines, and providing the highest quality quantitative support you can find.