Contract Research organizations A Business Overview Shannon Staton PharmD 2016

About Contract research organizations (CROs) provide clinical trial and other research support services for: Pharmaceutical industry Biotechnology industry Medical Device industry Government institutions Foundations Universities “A person or an organization (commercial, academic, other) contracted by the sponsor to perform one or more of a sponsors’ trial related duties and functions.”

Pharmaceutical Product Development: A CRO Company http://www.ppdi.com/About/CRO-Overview

References

Services Provided Project Management Database design & build Data entry & validation Clinical trial data management Medicine and disease coding Quality and metric reporting Statistical analysis plans and reports Validation programming Safety and efficacy summaries

Advantages = Cost Savings Organizations that contract with CROs are able to acquire specific expertise without having to hire permanent staff CROs reduce the time it takes to conduct a clinical trial versus an in-house trial

Regulatory Aspects Conducting proper clinical studies for submission to FDA and for the protection of the rights and welfare of subjects involved in clinical studies. Responsibilities: Obtain agency approval, where necessary, before studies begin. Manufacture and label investigational products appropriately. Initiate, withhold, or discontinue clinical trials as required. Refrain from commercialization of investigational products. Control the distribution and return of investigational products. Select qualified investigators to conduct studies. Disseminate appropriate information to investigators. Select qualified persons to monitor the conduct of studies. Adequately monitor clinical investigations. Evaluate and report adverse experiences. Maintain adequate records of studies. Submit progress reports and the final results of studies. Sponsors may transfer responsibility for any or all of these obligations to Contract Research Organizations (CROs) permitted by written agreement. Responsibilities that are not specified in a written agreement are not considered to be transferred. CROs are subject to the same regulatory actions as sponsors for any failure to perform any of the obligations assumed. Monitors are employed by sponsors or CROs to oversee the progress of an investigation.

Market Growth CROs are a relatively new Industry segment was extremely small a decade ago Analysts suggest the industry is growing by 4 to 12% annually Predicted increase from 30% to 60-80% outsourcing of clinical trials activities CRO sector generates over $30 billion The ten largest CROs control over 50% of the market share including: Quintiles Paraxel Covance Pharmaceutical Product Development Icon INC Research

Opportunities for Pharmacists There are a variety of career paths within CROs for pharmacists; responsibilities and approximate time spent on these: 30% research 15% project/case management 10% data management 8% business/organization/department management and service Two of the highest rated aspects of being a CRO pharmacist include: Applying scientific and medical knowledge Interacting with colleagues of different disciplines

References Background of Biosearch Monitoring. FDA, US Department of Health and Human Services, 2015. Available at: http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm134105.htm Silverman, E. Why Contract Organizations are So Hot. Forbes, 2011. Available at: http://www.forbes.com/sites/natalierobehmed/2015/09/11/how-akshay-kumar-became-one-of-the-worlds-highest-paid-actors/ Stone, K. Contract Research Organizations. About Money, 2012. Available at: http://pharma.about.com/od/C/g/Contract-Research-Organization-cro.htm Pharmaceutical Product Development, Available at: http://www.ppdi.com/