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Contract Research Organizations - CROs
- Driven by pharma's complex research initiatives and need to reduce product development costs; CROs are an increasingly important healthcare sector requiring highly focused marketing strategy
- Contract research organization post-approval monitoring is climbing due to advanced therapies, ongoing assessment of long term use and the interest in gaining more indications from individual therapies
... Learn about Health Economics Outcomes Research (HEOR) and Comparative Effectiveness Research (CER), explore the resources below ...
Contract Research Organization Overview
The top 10 CROs hold more than 50% of the market. This is expected to increase over the next few years in response to fluctuating R&D productivity, competition among the key CRO customer entities and expiring patents. By 2022, the worldwide CRO market is estimated to be worth $45 billion.
A series of sizable acquisitions have remade the CRO sector. LabCorp. announced in July, 2017 it was acquiring Chiltern for approximately $1.2 billion. Parexel was acquired by Pamplona Capital Management (a private equity / financial investment company) in mid-2017; the deal was valued at approximately $5 billion. In early May, '16 IMS Health extended an offer to acquire Quintiles for $9.2 billion. The new entity is comprised of 50,000 employees with exceptional healthcare data capabilities in commercial and clinical applications -plus enormous clinical research resources for pharma, device and other healthcare industry stakeholders...
- To reduce research & development costs, drug companies have outsourced greater portions of these functions to CROs to avoid inherent fixed costs of maintaining facilities and ongoing costs of compensating full time staff.
- The FDA is seeking deeper, more intricate data sets to base their approvals on, CROs have increased their clinical and analytical management resources to conduct more advanced, more introspective trials with better reporting.
- As pharmaceuticals become more complex (self-injectable therapies, biotech drugs, biosimilars, advanced oral agents) and medical devices more intricate, manufacturers are required to have more stringent production control processes in place, along with total quality assurance monitoring and advanced reporting, to meet approval standards.
- More companies are utilizing CROs in post-approval monitoring surveillance roles to satisfy FDA requirements, upping their game in ongoing quality control throughout the product lifecycle including variations in reported side effects, product quality and other measurable outcomes
- Pharma manufacturers are seeking the maximum number of indications for their molecules which enables them to get wider clearance for use by payers which generates more revenue; ongoing research drives these initiatives.
- To bolster the foundation upon which to make clinical / promotional claims, drug companies are more closely scrutinizing data in earlier stages of development for positive attributes which lend themselves to more marketing applications, CROs are responding to this with more revealing data sets.
- Increasingly, CROs are being actively engaged by pharma for actual trial design advice and other consultation as the CRO's have substantial experience derived from developing an array of molecules in different therapeutic classes and monitoring their quality levels.
- "Personalized" treatment paths of oncology demand unique clinical trial design and monitoring. The individualized approach to oncology treatment drives exploration and innovation; it has the potential to revolutionize treatment protocols and achieve positive outcomes.
Clinical and Commercial Challenges for Contract Research Organizations
Clinical research organizations have enormous business demands on their plates now and more to come. The FDA deploys Compliance Program Guidance Manuals (CPGM) to manage its field operatives on the inspectional and investigational activities regarding CROs and other research stakeholders. Their bioresearch monitoring activities, policies and regulations ensure the protection of research subjects and the integrity of data submitted to the agency in support of a drug approval application or other approval and licensing requests. This is in addition to municipal, State, Federal and other government agency oversight to reinforce all necessary measures required for accurate data and clinical research best practices for prescription drugs and other medical products.
To be competitive, CROs need to be able to deliver more advanced means of analysis and monitoring while keeping up with increased regulatory requirements and the changing, higher level requirements of clients and the industry. The growing sophistication of therapies needed to treat more challenging conditions requires a research infrastructure that allows for complex analysis to be conducted at an accelerated pace. If a product is approved, there is frequently additional needs for post-approval surveillance and added indication exploration. These are revenue opportunities for CROs but they require additional organizational resources to execute.
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards which apply to all clinical laboratory testing performed on humans in the United States with the exceptions of clinical trials and basic research. Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can begin analysis operations of human samples for diagnosis. CLIA regulations set quality standards for laboratory testing performed on specimens from humans (blood, body fluid, tissue) for diagnosis, assessment of health, prevention and treatment of disease.
... This is a list of Contract Research Organizations (CROs); scroll down for details about CDC CLIA-Certified Laboratories, Health Economics Outcomes Research (HEOR) and Comparative Effectiveness Research (CER) presentations and CRO market sector trends ...
... This CDC resource provides demographic information about CLIA-Certified Laboratories, including CLIA number, facility name, address and type of CLIA certificate ...
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