Clinical Research Organizations (CRO)

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:

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.