Verified Document

Clinical Trial Outsourcing Contract Issues In The Essay

Clinical Trial Outsourcing Contract Issues in the Outsourcing of Clinical Trials

The increasingly common practice of outsourcing clinical trials for pharmaceutical research and development is fraught with legal and ethical complications, especially as much of the outsourcing finds these clinical trials taking place in underdeveloped countries that lack infrastructure and appropriate civil and social oversight. In a scenario such as the one described, where an unequal partnership shares certain rights to the intellectual property and the physical substance that will be undergoing the clinical trial, new wrinkles in the responsibilities of parties and the necessities of established contracts arise. Looking to current research in the area can help determine the services and contract constraints that will be required to create an ethical and effective clinical trial that serves the immediate research and development needs of the pharmaceutical partnership hiring a central African...

Parts of this document are hidden

View Full Document
svg-one

A variety of medical and medical support services, from the recruitment of participants to initial examination to ongoing testing during the trial and many others, will be required as the fundamental operation of the trial (Rettig, 2000). There are also many accounting and legal services that will need to be procured, ensuring that the clinical trial meets with all relevant governmental criteria for United States/European standards and with the laws in place in the country selected for the trial, such that an entire industry of contract research has emerged (Sen & Shiel, 2006; Petryna, 2007; Rettig, 2000; Shuchman, 2007). These firms can ensure that all necessary services are adequately procured.
Clearly, contracting with a contract research organization to handle further contracting would be…

Sources used in this document:
References

Petryna R. (2007). Clinical Trials Offshored: On Private Sector Science and Public Health. BioSocieties 2:21-40.

Rettig, R. (2000). The industrialization of clinical research. Health Affairs 19(2): 129-46.

Shuchman, M. (2007). Commercializing Clinical Trials -- Risks and Benefits of the CRO Boom. New England Journal of Medicine 357: 1365-8.

Sen, F. & Shiel, M. (2006). From business process outsourcing (BPO) to knowledge process outsourcing (KPO): Some issues. Human Systems Management25(2): 145-55.
Cite this Document:
Copy Bibliography Citation

Related Documents

Clinical Research Administration Embracing the Scholar-Practitioner...
Words: 1117 Length: 3 Document Type: Essay

Clinical Research Administration Embracing the scholar-practitioner (SP) model in clinical research represents a critical responsibility to improve, to inform, and to inspire the lives of others: improve through scholarly research, inform through practical application, and inspire through leadership. During the semester, awareness was heightened as to the importance of scholarly writing, theory implementation, and leadership influence. Being charged with such responsibilities is not for the faint of heart. Becoming independent scholars

Clinical Research Ethics Medical Research Is the
Words: 1646 Length: 5 Document Type: Term Paper

Clinical Research Ethics Medical research is the most sensitive field of research in the entire field of academia. It is governed by several rules, regulations, and ethical standards. For instance, no research endeavor is allowed in case it hurts the life of any human being whether directly or indirectly. Secondly, any research that is to be done must meet environmental conservation measures and should not deride or harm human dignity in

Clinical Research and Nursing
Words: 662 Length: 2 Document Type: Essay

Membership in Professional Organizations Hospitals and other healthcare facilities observe patient experiences for assessing and improving care quality. As nursing professionals devote considerable time to their patients, they greatly influence patient experiences. For providing patients with superior quality healthcare, nursing staff must identify influential factors in the nursing environment. Patients' experiences in the care setting are recognized as markers of care quality assessment and improvement. When patient experiences are gauged by

Clinical Research and Discrimination
Words: 628 Length: 2 Document Type: Chapter

Letter to Support the Genetic Information Nondiscrimination Act of 2008 (GINA) The Genetic Information Nondiscrimination Act of 2008 (GINA) is an Act of U.S. Congress that makes it illegal for employers and health insurance companies to use genetic information against an individual. For instance, if a person has a genetic predisposition to a particular disease that runs in his or her family tree, an insurer is not allowed to use

Nurse Led Clinical Research: Neonatal Nurses' Perceptions
Words: 1279 Length: 5 Document Type: Essay

Nurse led clinical research: neonatal nurses' perceptions and experiences The aims of the study are to understand the experiences of clinical nurses in conducting and utilizing clinical research within their neonatal setting. This is a qualitative study of five neonatal nurses who were interviewed using semi-structured, face-to-face interviews to obtain the study data. This was a phenomenology-based study, which means it was meant to study the overall structure of the nurses experiences

Roles of Clinical Research Team Members the
Words: 570 Length: 2 Document Type: Term Paper

Roles of Clinical Research Team Members The relevance of a competently constituted clinical research team cannot be overstated when it comes to the success of clinical trials. This is true for both a site-based clinical research team and a sponsor-based clinical research team. Sponsor-Based Clinical Research Team Data Coordinator According to Robinson (2009, p. 9), "the primary role of a data coordinator is to ensure that the clinical trial database is accurate and complete,

Sign Up for Unlimited Study Help

Our semester plans gives you unlimited, unrestricted access to our entire library of resources —writing tools, guides, example essays, tutorials, class notes, and more.

Get Started Now