May 27, 2019
Bringing a new drug to the market is an expensive venture and can take up to 10 to 15 years from discovery to launch. Clinical trial costs are increasing and so is the complexity of managing it. According to the Tufts CSDD March 2019 Report, Sponsors are spending more on CROs for developing new medicines rather than their own internal team and infrastructure.
Budgeting for clinical trials can be a complex process with multiple variables that need to be properly accounted for and managed as assumptions. The following are the top challenges in the budgeting process for clinical trials:
The increase in Industry-Sponsored trials, Clinical sites are on the verge of looking to cut costs. There is a high unmet market need for a centralized automated solution to handle budgeting aspects such as billing and administrative functions. Clinical trial budgeting has acquired significance and plays a pivotal role to achieve the financial objectives and to drive operational efficiency.
With the right budget management solution, the budget created can be easily shared, submitted, reviewed and approved by any assigned authority, with an ability to set up process flows and approval process with a simple point and click steps. The solution provides complete audit tracking capability with details like what fields were changes on what date and by whom etc.
Sites play a very critical role in Clinical Trials and it’s very important that they get paid in a timely manner for the services they render. However, numerous surveys have shown that sites participating in studies face huge challenges related to timely payments leading to low satisfaction scores by sites on Sponsors and CROs.
Developing a new medication is a tedious process and costs of clinical research are constantly on the rise. These are the main reasons for the decreasing trend in the number of filings with the FDA.According to the U.S. Department of Health and Human Services (HHS), clinical trial procedure costs are the highest in the first three phases of the clinical study.
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