CLINICAL TRIALS FINANCE MANAGEMENT

      CLINICAL TRIALS FINANCE MANAGEMENT

Clinical trials financial services team assist clinical trials by contributing staff skilled in handling budgets, financial management and oversight of clinical trials.

 FINANCIAL SERVICE TEAM SUPPORTS CLINICAL TRIALS BY:

1) Analysing financials:

• Gives financial analysis support to both investigators and their study team across the life of a clinical trial.

• Explicate budgets and manage expenses.

• Make sure that the clinical trials are in compliance with the university policies/procedures and state/federal regulations.

2) Create reports:

• Produce twice a month economic reports that include netted income, increased expenses, and gives a summary information to both principal researchers and departmental peers.

• They collect and present the data in such a way that will be helpful in decision making.

3) Stalking study budgets vs actual costs:

• Prepare monthly summary budget variance reports for departmental administration.

• Analyse budget vs actual variances and communicate with clinical teams to assist with operational decision making.

• Monitor budgets and recommends action when there is a potential for deficit spending.

 4)Additional services:

• Ensure timely invoicing to sponsors and associated collections.

• They conduct fast and precise study to address over expenditure issues.

BUDGETING:

Present clinical research climate makes the planning and negotiating of study budgets and contracts stressful, time consuming, frustrating, and full of pitfalls. Because a clinical trial contract is a fixed price agreement, investigators are obliged to perform the act described in the contract, even if the definite costs go beyond the study agreements.

Successful budgeting thus requires a thorough understanding of direct and indirect expenses associated with performing clinical research.

DIRECT VS INDIRECT EXPENSES 

 These differ widely among institutions and countries.

By

Hema Durgasi (208/0621)

Pharm D

     REFERENCE:

     https://crsc.umn.edu/clinical-trial-accounting

https://ctsi.umn.edu/services/clinical-trials-financial-services

https://journals.lww.com/anesthesia-analgesia/Fulltext/2004/07000/Budget_Negotiation_for_Industry_Sponsored_Clinical.35.aspx