The services are derived from valuable 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, Ph.D., adding, “We’re developing proactive solutions to help avoid development delays for companies and maximize their return on R&D investment, enhancing our position as a leading drug development consulting firm focused on clinical pharmacology.”
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 rapid review and turnaround of a clinical study PK sampling schedule at minimal cost.
- 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 experienced PK advice without the expense of hiring full-time employees.
- Rapid Quote System: Time is money and time lost in development leads to higher costs. While interactions with other vendors can take weeks to obtain usable information related to cost and timelines, 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.
“These new services represent a unique paradigm for delivering clinical pharmacology drug development advice and guidance to the pharmaceutical industry,” said President & CEO Geoffrey Banks, Ph.D.
According to Dr. Banks, ClinPharm’s team of pharmacokineticists and clinical pharmacology consultants bring years of experience and knowledge to the new service offerings to ensure that drug development programs function as efficiently as possible.
ClinPharm Consulting will be participating in this fall’s American Association of Pharmaceutical Scientists Annual Meeting October 23-27 in Washington, D.C. For more information email discover@clinpharmconsulting.com or visit www.clinpharmconsulting.com.
ABOUT CLINPHARM CONSULTING
ClinPharm Consulting is a specialized consulting firm offering a unique paradigm for empowering drug development pipelines. Our business model focuses on matching scientific and pharmacokinetic/pharmacodynamic expertise with superior writing capabilities to maximize the impact of individual studies on an overall clinical pharmacology program. We specialize in helping small biopharmaceutical companies with minimal R&D infrastructure find scalable solutions for emerging early phase drug development challenges, providing an unmatched combination of technical expertise and robust understanding of clinical pharmacology from a scientific, regulatory and clinical conduct perspective.
The breadth of our experience allows ClinPharm Consulting to be a complete resource for clients to set up their drug development programs for success. ClinPharm Consulting typically engages clients as early as the IND planning stage to develop robust clinical pharmacology strategies and then works as a horizontally integrated, in-house resource to assist with the execution and analysis of those strategies. Our efforts not only include the design, conduct, and analysis of clinical pharmacology studies but also helping clients transition from nonclinical research into early phase clinical trials as well as transitioning from healthy volunteers into patients with the target disease. For more information, visit www.clinpharmconsulting.com
