Take on the role of the Research Manager, responsible for the review of CTA’s and budgets for upcoming trials to determine if they are adequate and if not to identify items that need to be negotiated with a sponsor. Based on the scenario presented in the assignment identify items from both the CTA and the budget for possible negotiation with the sponsor. Create a negotiation plan by responding to the questions for the assignment. Assignment to be 4 – 6 pages (1.5 or double-spaced) in APA format with references to support your work. (Objective 7)
Phase 3, multi-center IND clinical trial of adult males and females 45 – 75 years of age to compare the sponsor’s investigational drug to the standard of care drug in the treatment of coronary pulmonary obstructive disease (COPD),
Recruitment period is one year.
Upon enrollment the study will last 2 years (24 months).
After last patient visit (all sites), data lock will occur 3 months post.
Study close-out visit will occur 3 months post data lock.
The sponsor has contracted with a CRO to manage all aspects of the study.
Clinical Site Information
· Site is affiliated with a medical center
· Site conducts mostly phase 2 & 3 IND studies
· Each study coordinator is assigned 5 – 8 studies (dependent on study size, complexity, and number of subjects)
· All study coordinators are required to have a current national certification and have earned a bachelor’s degree.
· Coordinators have anywhere from 2 – 15 years of experience.
· Site metrics:
. 95% ability to meet recruitment goals
. Site has been existence for 20 years
. Site has conducted over 1,500 studies
. History of completing studies on time
. During its 20 years, the site has had 25 FDA inspections and received 8 FDA 483s; all of which were resolved promptly, CAPAswere created to address the observations, staff were retrained, and the issues have been resolved.
. Deviation rates have been less than 10%
. Violation rates less the 6%
· Site is located in a city that is ranked as one of the top five in the US for cost of living
· Staff salaries are 10 – 15% higher than industry standards
· Site policy requires that the sponsor cover any liability insurance
· Site charges 38% overhead
· Site prefers to be reimbursed per subject per visit
· Site wants no cap on the number of screen failures to be reimbursed by the sponsor
· Study billing is done through the medical center’s central billing office.
Sponsor/CRO’s Proposed CTA offers the site:
· $8,000 start-up fee
· Reimburse the site for 5 screen failures
· 30% overhead
· Procedure reimbursement rate is 10% lower than the site’s cost.
· Staff compensation is 10 -15% lower than the site’s cost
· Proposed site reimbursement by milestone payments.
· No reimbursement for staff time during monitor visits as they believe this a cost of doing business for the site.
Based on the scenario and the information provided create a negotiation plan. In your plan address the following questions:
1. What are the items you want to negotiate? List these according to site “needs” and “wants.”
2. How would you prepare for the negotiation with the CRO?
3. What would you provide as justification for each item you are negotiating?
4. What strategies would you use during the negotiation? Explain.
5. Summarize what you would consider and acceptable agreement between the site and the CRO. Explain.
Be creative. There are multiple ways to approach negotiation of the CTA and the budget. Provide appropriate headings and subheadings in your paper for easy transition.