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Contract Research Organization

    
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Allphase Clinical Research  Allphase Clinical Research is a clinical stage full-service Contract Research Organization (CRO) specializing in Respiratory, Oncology, Cardiovascular and CNS. Over the last 12 years we have run over 150 trials for small...
 
Clinical Monitoring Clinical Research Associates (CRAs) are appropriately qualified and industry recognized for their outstanding reputation in customer service, in-depth...
 
Data Management Allphase Clinical Research offers a full spectrum of data management services and expertise to ensure the efficient and appropriate management of your...
 
BASi - Bioanalytical Systems, Inc.  bioanalytical sample analysis automated in-vivo blood sampling toxicology pharmaceutical analysis electrochemistry EC liquid chromatography LC Vetronics
 
Drug Discovery Services BASi discovery services have a unique combination of highly skilled scientists, who place a premium on collaboration and trust, and proprietary instruments...
BioScience Laboratories, Inc.  A FDA / EPA registered, GLP and GCP, Microbiology, Virology, Toxicology analytical testing facility providing product safety / efficacy / custom testing, product development, product differentiation, and regulatory...
 
Agar Patch Agar patch clinical irritation testing
 
Antimicrobial Efficacy Testing BioScience Laboratories, Inc., (BSLI) is a leading resource for antimicrobial testing
 
Myriad RBM, Inc.  Myriad RBM is a CLIA-certified biomarker testing laboratory specializing in cost-effective, high-quality multiplexing services. Our protein immunoassays benefit drug discovery & development from preclinical through Phase...
 
Services Provided Myriad RBM, Inc. is the world’s leading multiplexed immunoassay testing laboratory, providing comprehensive protein biomarker services based on its...
Wockhardt  From development to high-volume commercial manufacture, they utilise more than twenty-five years of contract manufacturing experience to ensure your product is professionally managed all the way to market. The employment...
 
Controlled Drugs With Wockhardt's state of the art sterile injectable facility based in Wrexham in the UK, we are able to handle and process controlled drug substances with...
 
Formulation Services Alyante – is a Wockhardt Business Initiative focused on delivering timely and quality based development services to help improve your research efficiencies...
The Jackson Laboratory  We discover precise genomic solutions for disease and empower the global biomedical community in our shared quest to improve human health. We offer an array of scientific products and services to meet your research needs.
 
Jackson Laboratory Services We are an independent, nonprofit organization focusing on mammalian genetics research to advance human health. Our mission is to discover the genetic basis...
Metrics Contract Services  Metrics Contract Services is a CDMO offering contract pharmaceutical research, pharmaceutical development, clinical trial and commercial manufacturing services. Metrics provides FTIM development and Phase I, II and III...
 
Analytical Methods Development & Validation Metrics experienced scientists offer method development, validation and stability testing services to meet your challenging analytical needs and timelines...
 
Formulations Development Metrics provides pharmaceutical product development including pre-formulation studies, formulation development, Clinical trial batch manufacturing and...
NAMSA  NAMSA, North American Science Associates, medical device testing, medical device safety evaluation, medical devices, testing laboratory, contract research organization, medical device contract research organization
Alera Labs, LLC  Alera Labs, LLC -- Contract Research Organization (CRO) specializing in Advanced Analytical Method Development utilizing Liquid Chromatography and Gas Chromatography techniques
 
Method Development, Validation, and Transfer If you are in need of a challenging method development, you’ve come to the right place. Our scientists have expertise with virtually all possible classes of...
pHarma Associate Solutions  clinical research,clinical trials, clinical research training,cro, contract research organization,cra,clinical research associate, clinical monitor, pharma,medical research,clinical studies
 
Clinical Research Project Management Effective and efficient project management is an essential factor in ensuring the smooth, efficient running of a trial to timelines and budget. pHarma...
CE3 Inc.  CE3 is a contract research organization specializing in Phase I-IV clinical trials, with extensive experience in clinical trial management of challenging therapeutic areas, including oncology and infectious diseases.
ClinStar  ClinStar, HQ in CA, is a contract research organization (CRO) that manages Phase I-IV clinical research trials in Russia, Ukraine, Belarus and the Baltic States with fast patient enrollment, higher quality and passion for...
 
Clinical Affairs Our clinical team is well positioned, both geographically and culturally, to conduct your clinical trial in Russia and Eastern Europe.
 
Feasibility ClinStar eliminates guesswork at the study's outset, by conducting complementary accurate feasibility analyses for your work in Russia and Eastern Europe.
 
MRM Proteomics Inc.  MRM Proteomics is a contract research organization (CRO) providing protein biomarker quantification and proteomic services to pharma, biotech & diagnostics companies. Our multiplexed MRM Assays can quantify 10s to 100s of...
 
iTRAQ Protein Quantification Our iTRAQ protein Quantification Service is ideal for comparing normal, diseased, and drug-treated samples, time course studies, biological replicates and...
 
PeptiQuant™ Custom MRM Assays MRM Proteomics custom MRM assay service provides our customers with the ultimate flexibility in designing their own customized MRM assays. You can design...
 
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Contract Research Organization - Product Reviews

Clinical Research Organizations (CROs) aiming to streamline data processing while helping maneuver clients through regulatory morass.

Looking to break out of the role of discreet capacity for research and testing, some Clinical Research Organizations have widely expanded their competencies to include pharmaco-vigilance, data management, complete study analysis and auditing, and statistical strategy. Efficiency and speed to results are key factors in budgeting for CRO involvement, with many CROs providing relationships that provide partners as opposed to simply vendors of service.

Best in Class Clinical Research Organizations feature:

  • High quality data processing, warehousing and analysis – providing client-facing data reporting
  • Multi-national regulatory assistance and compliance protocols
  • Coordination with clients’ current technology stack and data sharing infrastructure

Top Considerations Before Investing in a CRO:

What’s happening in today’s CRO realm is indicative across horizontal markets: namely, outsourcing. The different twist are the adjunct capabilities CROs have rolled out recently that find clients allocating more budget to their chosen CRO. It is possible that you may want to completely outsource certain clinical trials including regulatory oversight – something often reserved for retained or internal legal counsel.

Additionally, CROs have begun to show proficiency in end-to-end study auditing – something buyers may choose to outsource to their CRO instead of spending months or years in development due to budget concerns or lack of internal resources.

Key Vendors

1. The Multi-Analyte Profiling (MAP) platform by Rules-Based Medicine (RBM), a multiplexed biomarker testing laboratory, focuses on streamlining drug development through reproducible immunoassay data for hundreds of proteins from small sample volumes. RBM enables research that historically was not available due to sample volume requirements and associated costs. Use of the testing services can identify the sources of both the positive and negative effects of drugs during pre-clinical research and clinical trials.

2. Spanning Phase I to IV, Cetero’s bioanalytical services drive clinical, preclinical drug and biomarker analysis for small and large molecules – while providing flexibility in the development process. Cetero Research is the product of a merger between five leading research companies: PRACS INSTITUTE LTD, Gateway Medical Research, BA Research, Allied Research International and dgd Research. Recently, Cetero announced that it has completed its announced it has completed its 50th definitive TQT trial in the last eight years. In addition to TQT studies, Cetero has performed numerous early phase trials with intensive cardiac monitoring.

3. Specializing in mouse models, The Jackson Laboratory focuses on education and collaboration. A non-profit, the Laboratory’s mission is to understand and stop the development and proliferation of disease. The Jackson Laboratory offers an extensive course and conference schedule from their Bar Harbor, ME headquarters focusing on topics ranging from embryo transfer to mammary stem cell training. The Lab provides opportunities for post-doctoral work and traveling and permanent faculty. In 2009, the Laboratory was voted #2 Best Place to Work in the United States in a poll of postdocs conducted by The Scientist.

4. Offering a range of services in all phases of development, Pharm-Olam International provides Pharmocovigilance to ensure their clients stay apprised of the dynamic regulatory environment in the multi-national drug development. Pharm-Olam’s biostatisticians consult on statistical needs from protocol design to dissemination of results across all therapeutic areas. From full project execution to supporting aspects of ongoing trials, our experts will Pharm-Olam offers collaborative services  for better decision-making.

5. With offices in the Netherlands, the United States and Europe, PRA International provides a range of services, including Late Phase (IIIb-IV) Studies & Registries that provide post-marketing studies in a variety of verticals. PRA's Risk Management Services team provides product life-cycle support from development through commercialization, allowing clear assessment and communication of efficacy and safety. Additionally, PRA serves as a leader in risk management and evaluation. Their services include: Product life-cycle Pharmacovigilance Plan, Risk Management Planning, Risk Evaluation and Mitigation Strategy (REMS), and Risk Management Plan (RMP).

Clinical Research Organizations:
Definition: A Contract Research Organization, also called a Clinical Research Organization or CRO, offers "outsourced" research support to the pharmaceutical and biotechnology industries. CROs provide clients with research services to aid in the drug and medical device research and development process, including product development, formulation and manufacturing; clinical trial management (preclinical through phase IV); clinical, medical and safety monitoring; preclinical, toxicology, and clinical laboratory services for processing trial samples; data management, biostatistics and biomedical writing services, especially in preparation for an FDA New Drug Application or NDA. See also drug development services.

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Contract Research Organization Research Library

Accelerating Generic Approvals: 5 Keys to Being First to Market
BASi - Bioanalytical Systems, Inc.
BASi White Paper: Accelerating Generic Approvals In the game of generics, the first to market is the winner. At a time when many of the most successful drugs are reaching the patent cliff, opening the floodgates for generic substitutes, generic companies are rushing to target the best candidates and enter the market first. And they are relying more heavily than ever on qualified outsource ...
 
Allphase Clinical - Risky Business
Allphase Clinical Research
Executing a clinical development program without sufficient resources, experience, and planning is akin to starting a war armed with a pea-shooter. This is a trend that has been developing during these recession plagued years. Despite the counter-intuitiveness of the approach, one can sympathize given the incessant ticking of the patent clock and the difficulties in securing and maintaining ...
 
Detection of Label Photoinitiator in a Potent Product: A Case Study
Metrics Contract Services
Detection of Label Photoinitiator in a Potent Product: A Case Study D. Williamson, M. Ruff, K. Rispress, J. Warren, F. Harrington OBJECTIVE To describe the detection and identification of a benzophenone, used as a bottle label photoinitiator, encountered during routine stability monitoring of a potent drug product utilizing a sensitive analytical method. BACKGROUND An unidentified peak (UNID) ...
 
An Overview of Assay Quality Systems at Rules-Based Medicine
Myriad RBM, Inc.
Stringent guidelines of quality assurance and control (QA/QC) serve as the foundation for dependable and reproducible results in any analytical endeavor. Read step-by-step how the RBM platform combines the sensitivity and dynamic range of microsphere based immuno-multiplexing with the precision and dependability of automated liquid handling.
 
Capsule Review on Bioanalytical Method Transfer
Frontage Laboratories, Inc.
With the globalization of drug development activities, transferring a validated bioanalytical procedure to a different site within a pharmaceutical company or to one, or multiple, contract research organizations has been dramatically increased in recent years.
 

Contract Research Organization Video

BASi Pharm Analysis Video BASi - Bioanalytical Systems, Inc. BASi scientists can provide support for all phases of your drug development, from early stage preclinical method development/sample analysis to ...
 
Meet Metrics Contract Services Metrics Contract Services
 
Contract Research Organization BioScience Laboratories, Inc. Company

Contract Research Organization News

Contract Research Organization Allphase Clinical Research Information
Contract Research Organization Wockhardt Company
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