Clinical Pharmacology Resources was founded to support the pharmaceutical industry with the wide range of skills and resources required to develop, apply and summarize a clinical pharmacology program that meets regulatory requirements from IND to NDA. With thirty years of experience in the pharmaceutical industry we can anticipate client needs and work efficiently in the multidisciplinary pharmaceutical industry environment.

In addition to protocol development, modeling and simulation, and noncompartmental analysis we provide support in areas that are often weak links in clinical pharmacology programs:

Monitoring

Integrity of pharmacokinetic and biomarker samples can be compromised by inaccurate documentation and processing. The problem has increased with the move towards collecting these samples in multi-center clinical trials where staff may be inexperienced or appropriate laboratory equipment may be inadequate at specific sites. We provide a more active role in the logistical aspects of clinical trial management and sample tracking when pharmacokinetic and biomarker data is being collected.

Programming

With the inclusion of PK/PD objectives in later Phase clinical trials designed to characterize safety and efficacy, clinical data programmers must now deal with dosing times, sample collection times, timing of adverse events, efficacy measurements and lab data, and compliance with food or concomitant medication requirements. All relevant information must be integrated and, most often, rendered as a NONMEM dataset complete with all of the NONMEM specific variables and flag settings. We provide NONMEM specific programming directly to pharmaceutical companies as well as to other pharmacometric service providers.

Translational PHARMACOLOGY

A tremendous amount of data is collected in clinical trials to address specific objectives but otherwise set aside.Mining this data not only arms the development team with valuable information regarding safety and efficicay but also completes the translational pharmacology loop. We provide this analysis.

These, together with traditional clinical pharmacology capabilities are covered more completely under the appropriate tabs. All of our services can be structured around definable objectives, billable hours or retainer. You will find our fee structure and skill set highly comparable to those of other clinical pharmacology and pharmacometric service providers.

Clients recieve FTP and HTTP access to a client specific subdomain on our server. This password secured repository may be used for data transfers, administrative activity, project updates, presentation material, literature, etc.

Please contact us for details.