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.

Sources Used in Documents:

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:

"A Cra S Initial Site Visit To A Pharmaceutical Firm" (2015, October 11) Retrieved April 20, 2024, from
https://www.paperdue.com/essay/a-cra-initial-site-visit-to-a-pharmaceutical-2156474

"A Cra S Initial Site Visit To A Pharmaceutical Firm" 11 October 2015. Web.20 April. 2024. <
https://www.paperdue.com/essay/a-cra-initial-site-visit-to-a-pharmaceutical-2156474>

"A Cra S Initial Site Visit To A Pharmaceutical Firm", 11 October 2015, Accessed.20 April. 2024,
https://www.paperdue.com/essay/a-cra-initial-site-visit-to-a-pharmaceutical-2156474

Related Documents

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

38 per share on the company's common stock for the first quarter of 2005. The dividend is payable January 3, 2005 to stockholders of records at the close of business on December 3, 2004. Growth in the ZETIA and VYTORIN franchises are expected to continue. T There are currently several candidates in Phase III that Merck plans to file in 2005 as well as Type 2 diabetes treatment and three vaccines.

There are two constant irritations in U.S. pharma companies' relationships internationally: Some developing nations, such as India, Brazil and South Africa, are chipping away at the patent situation, trying to shorten the time until the drugs can be brought out in generic form. The U.S. has supported high prices as the cost for innovation. Since other countries are not playing along, this means that their citizens are benefiting from the innovation paid

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

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 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