Verified Document

A Cra S Initial Site Visit To A Pharmaceutical Firm Business Plan

¶ … Clinical Research Associate (CRA) Visit to a Major Pharmaceutical Firm An agenda for the visit that you will send to the site prior to the visit

The agenda set forth in Table 1 below will be sent to the pharmaceutical firm preparatory to the site visit:

Agenda for CRA Site Visit

Activities

9:00-9:30 A.M.

Introductions and orientation

9:30-10:15 A.M.

Preliminary presentation to selected division chiefs and researchers concerning the CRA's role and responsibilities

10:15-10:30 A.M.

Break

10:30-12:00 A.M.

Meetings with researchers and clinicians in their divisions concerning purpose of clinical trials, relevant protocols and controlling legislation

a.m. -- 1:00 P.M.

Lunch

p.m. -- 2:00 P.M.

Review of research to date and findings

p.m. -- 3:00 P.M.

Meeting with pharmaceutical firm's staff attorneys concerning U.S. Food and Drug Administration requirements for clinical trials (Jackson, 2007)

3:00 p.m. -- 4:00 P.M.

Concluding presentation concerning the findings that emerged from the site visit

4:00 p.m. -- 4:30 P.M.

Questions and answers

The desired outcome of the visit (what you must know as a result of the visit)

The initial site visit should provide the CRA with the background information needed to formulate appropriate areas for oversight and identify...

Copies of all proposals and finalized studies for ongoing and planned clinical trials;
2. Findings from ongoing clinical trials; and,

3. A roster of the lead researchers and responsible executives (Hurst & Dennis, 2013).

A list of what you must collect from the site before you leave

The following information and items must be collected prior to the CRA's departure from the site:

1. An executed contract authorizing the CRA to perform oversight services for the pharmaceutical firm; and,

2. Copies of the items listed above.

A list of supplies for the visit (what you will bring with you to the site)

The following supplies will be taken to the site for the initial visit:

1. Handheld tape recorder for field notes;

2. A copy of the firm's organizational chart; and,

3. Legal pads and pens.

References

Hurst, C. & Dennis, B. (2013, Fall). Developing a clinical research associate training program at Dillard University: The impact of collaboration. ABNF Journal, 24(4), 104-107.

Jackson, L. A. (2007, June). A prescription for success: Finding career opportunities in the pharmaceutical industry. Black Enterprise, 36(11), 210-212.

Sources used in this document:
References

Hurst, C. & Dennis, B. (2013, Fall). Developing a clinical research associate training program at Dillard University: The impact of collaboration. ABNF Journal, 24(4), 104-107.

Jackson, L. A. (2007, June). A prescription for success: Finding career opportunities in the pharmaceutical industry. Black Enterprise, 36(11), 210-212.
Cite this Document:
Copy Bibliography Citation

Related Documents

Pharmaceutical Industry the Purpose of
Words: 2330 Length: 9 Document Type: Term Paper

This relationship has an effect on the payment rates that CMS sets. Higher cost pharmaceutical therapies are systematically reimbursed below acquisition cost (i.e., the payment system is biased against full reimbursement for higher cost therapies). Reimbursement compared to acquisition cost for the top IO pharmaceuticals by total expenditures indicates that 9 of the 10 are significantly under reimbursed." Clinical Trials Report: Congress established Medicare beneficiaries numbering 40 million with a prescription

Pharmaceutical Industry How Does the
Words: 1497 Length: 5 Document Type: Term Paper

For example, before its paten ran out, "the price of Schering-Plough's top-selling allergy pill, Claritin, was raised thirteen times over fives years, for a cumulative increase of more than 50%, over four times the rate of general inflation." In 2002, the average price of the fifty drugs most used by senior citizens was approximately $1,500 for a year's supply, and although this refers to what the companies call the

Pharmaceutical Industry and Sec
Words: 2811 Length: 8 Document Type: Research Paper

McKesson Corporation (Mckesson) is an American pharmaceutical distributor with operations mainly in the U.S. The firm has been in operation since 1833, and boasts extensive market share, robust financial strength, and strong market power. The firm has built strong relationships with its key stakeholders, which adds to its strengths. Nonetheless, limited diversification and market focus as well as the threats of competition, unfavourable regulatory changes, and counterfeits present significant concerns

Pharmaceutical Industry and Society
Words: 954 Length: 3 Document Type: Research Proposal

Sustainability in Pharmaceuticals Industry Ethical Pricing in the Pharmaceutical Industry The reality of medicine if the modern era is that resources must be allocated to help support the development of new pharmaceutical and in turn, there must also be a way to compensate those who devote their resources to help cure some of the preventable diseases that plague the modern age. The moral issue at stake here is distributive justice, and Rawls'

Pharmaceutical Industry and Drug
Words: 1613 Length: 5 Document Type: Essay

Drug Development (From Nature to the Market) The process of drug development is a complex one. The pharmaceutical industry is required to adhere to strict governmental regulations, set out by the Food and Drug Administration (FDA), which involve numerous phases of testing and clinical trials, close monitoring of the drug's effects on users, its stability, dosage forms (the preparation), and so on. This paper will describe the drug development process,

Ethical Dilemma Faced by the Pharmaceutical Industry
Words: 1665 Length: 6 Document Type: Research Paper

Pharmaceutical Ethics Issues Generally, business ethics is a concept that has not been upheld or exemplified to any high standard by the modern pharmaceutical industry. It is an industry frequently plagued by unethical marketing decisions and practices, the pursuit of business strategies and policies that violate public trust in spirit if not necessarily in the written word, and that has embraced research practices that are sometimes highly questionable. In the modern

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