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Bioanalytical Lab: Fargo

We provide responsive, timely services

PRACS builds client confidence with experienced staff providing responsive, flexible and timely services. Our experienced staff understands the necessity of prompt, effective, timely communication to the sponsor on project status. Our team approach to project management assures day-to-day continuity in sample analysis while focusing on quality and timelines as well as assuring communication.

Our bioanalytical laboratory features state-of-the-art equipment to analyze and quantify single and multi-source drug samples. Fully computerized records of each analysis are strictly maintained in both electronic and hardcopy format.

Our facility is state-of-the-art

Due to the growth in our bioanalytical laboratory staff and equipment needs, we moved the laboratory to a new 15,000 square foot space in our new Amber Valley headquarters in early 2004. Our laboratory is equipped with a wide range of analytical instrumentation including HPLC-UV, LC-MS and LC-MS-MS (both Micromass and Sciex). Each instrument is software controlled for high-end computerized sample analysis, documentation and security.

We meet and exceed GLP standards in monitoring our systems.
Our bioanalytical assay methods, software and spreadsheets are fully validated to enhance your peace of mind and support our audit trail.
Our data is readily available for electronic FDA submission.

We've made quality staffing a top priority

Our director and senior analytical staff have many years of industry experience from both CRO and innovator pharmaceutical companies. They have a solid reputation for understanding and following GLP and FDA guidelines.
Documentation and review of staff training files is standard procedure.
Data management staff assigned to each team assure in-process data integrity (quality control).
Data management and team leaders work in conjunction to assure post-project data assessment.
Our metrology staff support each bioanalytical team for timely equipment maintenance and to minimize equipment down time.

Bioanalytical Method Development and Validation
Our bioanalytical method development team represents an experienced group of individuals well suited for the challenges of blending the art and science of method development to create rugged, reproducible and time sensitive validated methods.

We are experienced at developing bioanalytical methods and validating the method according to FDA standards.
We have experience in cross validating bioanalytical methods.
Our bioanalytical services are available for both in-house and external trials.

We specialize in convenience and flexibility.

Our staff has experience with a variety of parent and metabolite compounds. Their years of experiential knowledge augments both innovative method development.
If requested, interim data reports are available throughout sample analysis. Or, if requested, our in-house statistical staff can provide interim analysis of your data for your perusal on demand.
Our Midwestern work ethic and efficiency leads to fast, accurate analysis at competitive prices.
Our staff will work as an extension of your bioanalytical team to ensure quality reports and timely FDA submissions.