What should you expect from a research leader?
Whether you have partnered successfully with contract research organizations in the past, or are testing the waters for the very first time, it's common to have questions. More importantly, it's imperative to get the right answers.
Based on 25+ years of research experience, we've gathered together a few of the most common questions posed by clients and partners. Asking these questions of any prospective contract research organization will help ensure that your company partners with, not only the very best research team, but the research team that's best suited to you and your research objectives.
Can I be confident that XenoBiotic Laboratories (XBL) will be able to address my project needs?
Absolutely. XBL has established a long track record of providing reliable, quality contract services to the pharmaceutical, animal health, agrochemical and allied industries. Detailed, early discussions with our senior scientific team—a team that draws on many years of conducting challenging studies—help to ensure a complete understanding of your project details and plan for a best practices approach.
Does XBL establish a series of benchmarks for keeping sponsors updated?
Yes. In conjunction with each sponsor, XBL establishes project protocol and data reporting milestones for every project to enable optimal, seamless communication during each stage of research.
Does XBL provide study design guidance?
Yes. XBL will work with you to ensure the best possible study design for your research project. XBL can work with your protocol, following the most exacting requirements, or develop a study protocol in house that addresses your drug development needs.
Can XBL assist with both preclinical and clinical research projects?
Yes. XBL has the extensive experience to assist you with your drug development needs from the discovery phase, through in vitro metabolism, to in vivo PK and ADME studies, to clinical trial sample analysis and human mass balance studies. XBL can work with you to develop new validated methods or to cross-validate an existing method in pre-clinical or clinical matrices.
What type of communication system can I expect when working with the scientific staff at XBL?
XBL ensures that answers to your questions are within easy reach by phone or e-mail. Our senior management and scientific team are always available to work with you. Someone knowledgeable about your program is always quickly available to assist with questions, scope discussions or project progress.
Once we agree to conduct a project at XBL, how long will it be before the project is initiated?
Availability of drug/test articles/test systems/standards is often the time limiting factor after a project agreement has been signed. With rapid provision of an appropriate protocol, a study is generally scheduled to meet our sponsor's timelines. During preliminary discussions, your needs guide us as we develop the proposal. Often projects can be initiated within one to two weeks of proposal approval, depending upon the scope and availability of key materials.
What steps are taken at XBL to search for unknown metabolites?
The latest in LC/MS equipment, including Thermo LTQ Orbitrap XL, Sciex 4000 Q-Trap™, and Waters Xevo TQ-S provide precise sensitivity and specificity in the hands of XBL's experienced scientists. Dozens of years of combined knowledge in metabolite searching and identification are at your project's disposal. Our approach ensures a detailed and thorough evaluation of your unique product's biotransformation profile, including identification of anticipated, as well as unexpected, metabolites.
Can XBL determine the chemical structure of unknown metabolites, impurities or degradation products?
This is one of the most unique strengths within XBL. In addition to advanced LC/MS instrumentation with accurate mass measurement capability, XBL has on-site NMR instrumentation (500 MHz) with microcell sample set-up. With this instrumentation, we are able to analyze microgram quantities of unknown samples to obtain 1-D and 2-D1H and/or 13C NMR spectra to aid in the structure elucidation process.
Is XBL audited/inspected by the FDA or other regulatory agencies?
The FDA, EPA, USDA and NRC have audited XBL with satisfactory results. In addition to this wide array of regulatory agencies, XBL is regularly audited for GLP compliance by our sponsors, which include many of the world's leading pharmaceutical, animal health and allied companies. XBL's studies are often included in worldwide regulatory filings, including INDs, NDAs, ANDAs and related submissions. XBL's facility is licensed for radiolabel work by the State of New Jersey, DEA licensed at the federal and state levels for research with controlled substances, and AAALAC accredited for pre-clinical studies.