Why Estimation Accuracy Matters For The FDA Approval Process

Accuracy matters. In fact, a minor inaccuracy during the FDA approval process can end up costing your organization an average of a million dollars a day for an average of three months. And if your CRO doesn’t provide you with an accurate estimate, you can start adding significant costs on top of that.

It’s a common tale. You get an estimate from your CRO. Then you find out the estimate was not actually all inclusive. There’s additional spending on this or that, and it’s not peanuts. The costs are significant. However, you’re now locked into working with this CRO. Switching horses in the middle of the race is more costly in terms of both time and money than just seeing the thing through.

In fact, some sponsors have come to accept that CRO estimates will necessarily never be accurate. You’ve settled on simply finding the least inaccurate estimate you can. Maybe you’ve even started budgeting for extra spending later on during the approvals process. Not only does this make your costs unpredictable, it’s also unnecessary.

Common reasons for increased costs include:

• Extended Timelines: The length of a project is frequently closely tied to its overall cost. Delays in your timeline mean increased costs.

• Amended Protocols: Whenever a study design gets reworked, the means a lot of time — and a lot of money.

• Changing Analysis Plan: When data is analyzed and presented differently, there will be a lot of reworking of the data. That’s going to be very expensive. Nailing down just how you plan to analyze and present data up front will ensure you don’t run into any surprise charges later.

Many times what this boils down to is a poor fit. The partner CRO either works in a field different than yours or, for some other reason, doesn’t fully understand your needs. Thus, they can’t provide an accurate estimate. And that’s just the beginning of your troubles.

Accuracy with your data begins with an accurate estimate. A partner organization who can’t accurately estimate your costs is more likely to have trouble providing you with accurate data later on down the line. What’s more, your financials can’t be beholden to the vagaries of a partner CRO.

The right biostatistics CRO focusing on data analysis can provide you with accurate results in line with your original budget. What’s more, they can even find places where other partners have provided inaccurate data, allowing you to avoid potentially expensive headaches in the FDA approval process.

Read our free recent white paper on the why and how of selecting a biostatistics CRO on the basis of accuracy. Inside we discuss the stakes, common pitfalls and how you can avoid working with an inaccurate CRO ever again, starting with your estimate. This can save your organization millions and help to ensure your drug gets to market before any of your competitors.

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