ClinPharm Consulting Launches New Services

ClinPharm Consulting is offering new services to enable biopharmaceutical companies to reduce drug development risks and maximize return on R&D investment.

The services are derived from insights into preventable issues revealed by the firm’s clinical pharmacology and PK-PD work across numerous client projects.

“Our new services arise from important concepts that our clients are seeking, including sound strategic and scientific advice and rapid delivery of services at an affordable cost,” said ClinPharm Consulting’s Chief Scientific Officer, Bill Wargin, PhD, adding, “We’re developing proactive solutions to help avoid development delays for companies and maximize their return on R&D investment.”

The new services offered by ClinPharm Consulting include the following:

• PK Sample Schedule Evaluation: ClinPharm Consulting has identified a critical risk in drug development, which is the development of an optimal 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 review and turnaround of a clinical study PK sampling schedule.

• PK Help Desk: 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 analysis (e.g., between cohorts in an ascending dose study).

• Virtual Clinical Pharmacology/PK Group: 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 PK advice without hiring full-time employees.

• Rapid Quote System: ClinPharm Consulting has established a new web portal to allow clients to obtain a rapid quote for common services without the need for a confidentiality agreement. By collecting general non-confidential details, clients can receive an estimate for costs and a project scope within 24 hours or less.

In addition to these new services, ClinPharm Consulting is seeing growing interest in customized clinical pharmacology plans to address important issues and prevent delays in clinical studies, providing a road map to clients’ programs and identifying key areas to avoid risk.