Are you aware of the hidden biometrics costs in your clinical trials?
Where are you losing valuable time and money?
When managing a clinical trial, it is natural to focus on the obvious costs.
But what about the costs you do not see?
Hidden challenges can quietly inflate budgets and delay timelines, often without anyone realizing where things went wrong.
These hidden costs stem from more than just systems and processes, they arise from how teams work together. In this blog post, we will uncover the visible and hidden costs of biometrics in clinical trials and, more importantly, share how you can tackle them to stay on track and within budget.
What do biometrics costs cover?
Biometrics is all about the data in your clinical trial.
From collecting, analyzing, and reporting it – these are the steps that ensure the data is accurate, validated, and also meets the regulatory standards required for approval.
Most of the visible biometrics costs come from:
- Size – the bigger the trial, the more data there is to manage, and therefore a higher cost.
- Complexity – intricate protocols or multiple endpoints make trials even harder to manage, thus complex.
- Therapeutic area – specialized fields like oncology often need unique expertise.
- Duration – longer trials mean higher costs over time.
- Reporting and regulatory requirements – meeting strict compliance standards takes time and effort.
While these factors are well-known and planned for, the hidden drivers of biometrics costs are often overlooked – and these can disrupt even the most carefully managed trials.
The hidden drivers of biometrics costs
Hidden cost drivers are not always easy to spot.
They are often linked to how teams communicate, coordinate, and adapt to challenges in the moment.
Let us have a closer look:
Clinical trials bring together a wide range of stakeholders, such as statisticians, project managers, laboratory staff, and medical monitors.
Each team has different priorities and processes, and when these are not aligned, things can easily go wrong from there.
For example, data analysis teams may need information in a specific format, but if this requirement is not communicated clearly to data collection teams, you could end up with delays, errors, or even rework.
A source of solution is to build stronger connections between teams by embracing open communication and making sure everyone understands each other’s needs. Structured meetings, shared documentation, and clearly defined handoffs can make a significant difference.
Without clear agreements on timelines, data formats, or quality standards, it is easy for confusion to creep in.
If no one specifies how or when for example lab results can or should be delivered, it can lead to errors that take time to fix.
By agreeing on expectations upfront, and creating detailed documentation that outlines roles, timelines, and deliverables, this ensures clarity from the start. Consistently revisiting these agreements throughout the trial keeps everyone aligned.
Changes to trial protocols are sometimes necessary, but each amendment creates a certain chain reaction.
Databases need updating, analysis plans must be revised, and parts of data must be revalidated.
And then it is back to square one.
It is not about avoiding change. It is about managing it effectively. Planning for potential updates and communicating changes clearly can help minimize disruptions and enhance the feeling of involvement within each of the teams.
While it is great to have an involved team, having too many people making decisions can slow things and create confusion – not to mention frustration.
Accountability becomes unclear, and tasks are often duplicated or delayed.
By effectively mapping out the number of decision-makers and giving each person clear responsibilities, you can avoid inefficiencies and keep the project moving forward, preventing anything from falling between two stools.
Disorganized review processes can drag out timelines unnecessarily.
If feedback is fragmented or redundant, it takes much longer to finalize key deliverables like statistical analyses or regulatory submissions.
Creating a consolidated and structured review process ensures that teams stay aligned and timelines are met without extra delays.
Take control of your biometrics costs
Clinical trials are a team effort, and biometrics is at the heart of making your trial a success.
While visible costs are easy to track, it is the hidden costs, arising from lack of precise contractual agreements, communication, poor coordination, and unclear responsibilities, that can cause the most disruption in the daily workflow.
By focusing on how teams work together and addressing these hidden cost drivers, you can save valuable time and money.
At BioStata, we understand the human side of biometrics.
We specialize in helping sponsors manage their clinical trial data with clarity and efficiency, while ensuring that:
- your processes run smoothly
- your teams stay aligned
- your trial stays on budget.
Reach out and we will be happy to help with regaining a comprehensive overlook of all your costs.
Do you need help identifying your hidden biometrics costs?
Fill out the form, and we will get back to you to answer any questions or discuss a potential meeting.