New Resources

ClinPharm has developed a series of resources for rapid and efficient delivery of strategic guidance to clients for their pharmacokinetic and general clinical pharmacology needs.

ClinPharm has identified important methods in the delivery of pharmacokinetic consulting services to de-risk drug development programs and has launched a series of resources targeted at providing the most useful strategic advice to clients in an efficient and cost effective manner. A critical component that ClinPharm has identified for a successful clinical study is to have an evaluation of the pharmacokinetic and/or pharmacodynamic sampling schedule. As such, we have launched a standalone service for clients to obtain feedback from ClinPharm regarding an optimal sampling schedule for their clinical studies. In addition, to address rapidly emerging issues in drug development programs, ClinPharm has launched a PK help desk for quick feedback and a virtual clinical pharmacology/PK group service to handle more in-depth issues and topics.

Overall, ClinPharm’s new services provide rapid access to our extensive technical expertise in drug development and complete understanding of clinical pharmacology from a pharmacokinetic, scientific, regulatory, and clinical conduct perspective.

PK Help Desk

The PK help desk is a PK hotline that allows “on call” access to experienced pharmacokineticists and clinical pharmacology consultants. This service is for clients who anticipate needing quick advice, fast confirmation of PK strategy (e.g., during the FDA’s 30 day IND review window), or rapid turnaround of PK analyses (e.g., between cohorts in an ascending dose study).

Virtual Clinical Pharmacology/PK Group

The virtual group model is an expanded version of the PK help desk that allows ClinPharm to work as an extension of a client’s R&D team to provide experienced PK advice without the expense of hiring full-time employees by the client. This is not a project management role but rather a full service virtual group model that the client can comfortably rely on for emerging pharmacokinetic, drug metabolism, and clinical pharmacology topics within their ongoing development programs.

PK Sample Schedule Evaluation Service

A critical risk in drug development is a sub-optimal PK – PD sampling schedule in clinical studies assessing pharmacokinetics. An inadequate PK sampling schedule can lead to sub-optimal PK data (e.g., inadequate half-life determination) that can impact downstream decisions in development programs (e.g., selection of a dosing interval such as once daily, twice daily, etc.). ClinPharm Consulting now provides rapid review and turnaround of a clinical study PK sampling schedule at minimal cost.

Please contact us at discover@clinpharmconsulting.com or 1-888-615-5111 to set up access to these resources or submit a request for a Quote.