Preclinical and Nonclinical Research
From bench to kinetics, toxicity and carcinogenicity. |
Xenometrics LLC
Xenometrics LLC is a nonclinical contract laboratory with expertise in safety pharmacology, ADME, toxicological testing and discovery support services designed to address pertinent pharmaceutical drug discovery and safety issues. Xenometrics sets out on a mission of providing scientific research expertise to the biotechnology and pharmaceutical industry.
XenoTech, LLC
XenoTech is a Contract Research Organization (CRO) serving clients with their unparalleled experience and expertise in evaluating drug candidates as substrates, inhibitors and inducers of cytochrome P450 enzymes. They offer a variety of in vitro contract studies for drug candidate evaluation, as well as an extensive selection of products for drug metabolism research.
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Drug Substance Manufacturing
Resources for both large and small concerns. |
SAFC Biosciences is the world’s leading supplier of cell-culture reagents to producers of marketed biological products. They are committed to supplying high-quality critical raw materials and specialized cell-culture products to the global health care industry. They provide highly customized services to cell-culture-based manufacturing companies.
Bayer Healthcare LLC
With a large presence in Shawnee, Kansas, Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the health care and medical products industry. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. Bayer Healthcare’s aim is to discover and manufacture products that will improve human and animal health worldwide.
Aptuit, Inc.
Aptuit is a drug development and pharmaceutical services company conducting research, development and manufacturing on a global contract basis for both large and small innovators. Their mission is to “engineer a better drug development process” to serve these two very different clients equally well but in very different ways. First, they are assembling a complete suite of services from discovery to proof-of-concept and constructing the related manufacturing services from discovery to launch. Along the way, they are opportunistically inventing and acquiring novel technologies and services that allow clients to differentiate their drug development programs.
Remel, part of Thermo Fisher Scientific
Since beginning in 1973, Remel has grown from a small, regional manufacturer of prepared culture media to a global provider of high-quality microbiology products and a part of Thermo Fisher Scientific, the world leader in serving science. Their extensive product portfolio is used in clinical, industrial, research and academic laboratories around the world. Remel products include: prepared culture media; dehydrated culture media; collection and transport systems; diagnostic tests; direct specimen tests; quality control systems; and laboratory supplies.
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Contract Research
The world’s leading resources. Centrally located. |
PRA International
PRA is one of the world’s leading global clinical development organizations with more than 3,000 employees worldwide delivering reliable service, program-level therapeutic expertise, easy global access to knowledge and an involved senior management to customers. PRA recently expanded their clinical pharmacology unit in Lenexa, Kansas, from 50 to 80 beds to run high-end Phase 1 studies from first in men to proof-of-concept studies.
Quintiles Inc.
Quintiles product development services provide all clinical research aimed at regulatory approval, and post-launch research and consulting on product safety and value. Quintiles offers: Phase I Services for early phase human drug development; Global Clinical Development Services, encompassing all Phase II-IV trial services, such as clinical trial management, medical and regulatory affairs, biostatistics, patient recruitment, ECG services, and drug safety and strategic research; global central labs to support all phases of clinical trials; global data management to capture, analyze and report patient-related data; global consulting on product development, reimbursement and pricing, health outcomes, regulatory compliance (e.g., FDA enforcement, quality systems), and due diligence for pharmaceutical, biotech and medical device companies; and Medical Education involving the development and delivery of Continuing Medical Education (CME) programs for health care practitioners.
Vince & Associates Clinical Research
Vince & Associates Clinical Research is a provider of clinical trial services to the pharmaceutical and biotechnology industries. The company specializes in central nervous system research and sleep disorders research, and has experience in conducting overnight and outpatient studies.
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Safety, Efficacy and Esoteric Testing
Gain pipeline flexibility and a reduction in fixed costs and special equipment. |
IBT Laboratories
For more than 25 years our focus has been on Immunology and Allergy research and testing. We pride ourselves in being industry experts having supported and complemented the world's largest pharmaceutical and biotech companies with assay development and validation of Immunogenicity Assays, Neutralizing Antibodies, Immunophenotyping, Biomarkers, Cytokines, PBMC Isolation, T-cell and B-cell Assays, ELISPOT and Allergen Specific Response. For non-clinical through Phase IV services, IBT has the extensive experience to address clinical safety and efficacy for FDA and other global regulatory agency submissions.
PRL Central Laboratory Services
PRL Central Laboratory specializes in comprehensive diagnostic and clinical trial testing, including anatomic pathology and molecular diagnostics. PRL services all phases of global clinical trials.
Clinical Reference Laboratory (CRL)
CRL is a privately held reference laboratory offering leading-edge testing services in the areas of clinical trials, corporate wellness programs, genomics, insurance and toxicology, all under one roof in a state-of-the-art facility in Lenexa, Kansas. They currently have more than 500 employees, a 192,000 plus square foot “campus” and perform tests on millions of samples annually for hundreds of clients. These factors make CRL one of the largest privately held laboratories operating on a national basis. In addition, CRL has had the same core management group for the past 18 years and has operated profitably in each of those years.
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Regulatory Consulting
Best-in-class resources. All right here. |
Beckloff Associates, a Cardinal Health Company
Beckloff Associates is a full-service pharmaceutical research and development consulting firm that specializes in supporting the pharmaceutical, biotechnology and medical device industry. Beckloff Associates provides solutions through global regulatory and product development planning, total program management, regulatory authority interaction, regulatory documentation preparation, regulatory publishing and compliance programs.
Quintiles Inc.
Quintiles Regulatory Services provides critical strategic and tactical solutions that facilitate the achievement of regulatory and product development milestones for drugs and biologics. Their focus is on strategy, planning, implementation and training for all phases of the regulatory review and approval process. Quintiles’ regulatory applications teams bring together – under a dedicated project manager – incredibly talented regulatory strategists, medical writers, biostatisticians, and medical, publishing and clinical pharmacology specialists who work closely together to design and implement efficient, effective
regulatory applications from beginning to end. Their team will help you to navigate through the complex registration procedures in the U.S., Europe and across the globe to achieve the fastest launch to market.
PRA International
PRA’s Regulatory Affairs team has daily use knowledge of regional regulatory requirements across the globe. We offer competitive product development plans, rapid study startup and effective submissions strategies. This is possible through close collaboration with multi-functional project teams that support early clinical trial development, product registration and late phase trials. Our partnership with PRA's Analysis & Reporting and Safety & Risk Management groups has proven instrumental in ensuring successful development programs.
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