Budgeting for a clinical trial is challenging. Clinical trial sponsors do their best to anticipate every dollar they will need, but there are always unforeseen costs that emerge.
It’s better to be prepared for the unexpected than surprised by it later. An experienced clinical research organization (CRO) like ours has been through many clinical trials before, so they know what to expect and where teams most often encounter unforeseen costs.
Here are the four most significant areas where costs can add up.
The Biggest Clinical Trial Budget-Busters
Clinical Trial Delays
Many clinical trials experience enrollment delays, site start-up delays, or product availability delays, which can increase costs. Delays mean potentially higher IRB fees, more monitoring visits, more site selection and start-up costs and more staff turnover. Turnover leads to more training, which also adds to your costs.
Every day of delay also means one less day that your device is not on the market bringing in revenue for your company.
A good CRO will be eager to offer to help with other areas of your trial. However, it’s important to make sure you’re not unintentionally adding to the scope of the project when you ask them for help with something that isn’t included in the agreement. That could include:
- Training your team in the fundamentals of good clinical research
- Supporting your in-house team with additional monitoring
- Assisting with data management
- Assembling a data safety management board (DSMB) or clinical events committee (CEC) to assist with safety monitoring
- Conducting an audit to prepare your team for an inspection
While you should always consider additional services when they make sense for your trial, the right CRO will be transparent about any additional costs to your company.
Managing clinical sites, especially in an IDE study, often involves frequent travel, which costs money.
The travel costs associated with a clinical trial can be significant.
A good CRO will help you determine which study tasks can be done remotely and which are essential to do on-site.
For instance, conducting a trial master file review that requires several team members to be on site for several days can cost upwards of $10,000 when travel costs are factored in. Conducting the same trial master file review remotely can cut that cost in half.
Staff turnover is one of the most frustrating challenges clinical trial teams face, whether it’s the loss of in-house team members or turnover within your CRO or other vendors.
It’s also costly. Each new hire requires onboarding time and additional training to ensure compliance. The current industry average for CRO turnover is hovering around 30%, a five-year high, according to the ACRP.
Your team can minimize this common clinical research budget-buster by hiring a CRO with a proven track record and turnover that is below the industry average.
How To Choose A Budget-Friendly CRO
A clinical trial is a marathon, not a sprint. You want to hire a contract research organization who will serve as a true partner and protect your budget over the long haul. The right CRO will treat your budget like their own. They will provide an accurate estimate to help you budget and contain costs throughout the study. That includes making adjustments as needed and communicating any additional costs to your team before billing you for extra charges.
A CRO can help your trial stay on track and on budget, provided you’ve accounted for the cost of their services. This whitepaper will cover everything you need to know to budget for a CRO, from getting buy-in to avoiding unexpected costs.
Please take time to download this valuable resource and learn what to expect when budgeting for a CRO.