Product and Services Finder

Contract Research Organization

    
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CNBE  CNBE is a CRO specialized in exploratory animal studies: toxicity, PK and drug efficacy studies in numerous animal models (rodents, rabbits, cotton rats, ferrets, farm animals, dogs and non-human primates). CNBE is GAP...
 
CNBE Animal facility description CNBE is GAP (Good Animal Practice) certified and has CCAC and AAALAC accreditations. CNBE has 78 multifunctional animal housing rooms (130,000 sq. ft.) for...
 
CNBE Detailled CRO services CNBE offers turnkey contract research in 1. toxicity (DRF, MTD, NOAEL, NOEL), 2. pharmacokinetic and 3. drug efficacy (proof-of-concept) in many areas...
 
NDI ADRL Inc. dba Diteba  Diteba is a development and testing laboratory that provides GMP analytical and GLP bioanalytical testing services from pre-clinical to Phase IV testing from method development and validation to QC Release, In Vitro...
 
Analytical Chemistry Services Analytical Services, Outsourcing Services
 
Bioanalytical Testing Equipment Diteba has invested in all new state-of-the-art bioanalytical testing equipment including: Ultra Performance Liquid Chromatography Systems (Waters...
 
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...
 
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...
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...
ImmunoSite Technologies, LLC  Contract Research Services provider of assay automation and product development for the Life Sciences, and particle testing for manufacturing QC.
 
Assay Automation Services For when you have to do more with less by yesterday!
 
Medical Device Development Support Support for Medical Device Product Development
 
Medidata Solutions  Medidata's advanced cloud-based platform lowers the total cost of clinical development by optimizing clinical trials from concept to conclusion.
 
Medidata CRO Contractor® Medidata CRO Contractor® provides clinical research sponsors the benchmarking data and analysis tools to optimize the critical relationship with their...
Nuvisan Pharma Services  Bioanalytics, Immunology, Phase I/IIa (CPU) unit, Clinical Trial Supplies, Stability, Analytical, full service Phase II-IV, Pharmaceutical Analytics, Formulation Development, CDM & Biostatistics, and Regulatory Affairs
 
Bioanalytical Services Service Overview: -Bioanalytical capabilities to support the analysis of both large and small molecules -Bioanalytical method development and validation...
Metrics, Inc  Metrics Inc. 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 CTM.
 
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...
Lyophilization Technology, Inc.  Lyophilization Technology, Inc. offers thermal analysis, formulation development, process engineering, clinical supplies manufacturing, & technical support for freeze dried pharmaceuticals, biologics, diagnostics,...
 
Contract Research Organization Development services are conducted with a product quality and manufacturing mindset. This entails considering product administration, stability and...
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...
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...
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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

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 ...
 
An Alternative Approach to Bioequivalency Studies Utilizing In Vitro Release Rate Studies
NDI ADRL Inc. dba Diteba
Find out how you can optimize your formula for in-process testing, control quality better and avoid lot-to-lot variability and be in full compliance with SUPAC and FDA guidelines for pre and post-change formulations, manufacturing site transfers, using skin penetration studies for BA/BE evaluations and interpreting the data generated for SUPAC submissions.
 
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.
 
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 ...
 
Using Quality by Design (QbD) for Process Optimization of a Novel Oral Solid Dosage Form
Metrics, Inc
Joe Cobb and his team used the principles of QbD to improve the robustness of a core tablet for a novel modified release oral solid dosage form. View the AAPS 2012 poster and watch a short video about how Metrics applies the principles of QbD to solve formulation development issues.
 

Contract Research Organization Video

Diteba's Capabilities Presentation NDI ADRL Inc. dba Diteba Explore Diteba's Laboratory Testing capabilities and find out how we can help you turn your research into reality and expedite the process of bringing ...
 
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 ...
 
Contract Research Organization CNBE Pharmaceuticals

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Contract Research Organization Wockhardt Information
Contract Research Organization Lyophilization Technology, Inc. Pharmaceuticals
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