In clinical research, Sponsors are under constant pressure to do more with less. They must cut costs, speed up timelines, and navigate growing regulatory complexity — all while delivering reliable, high-quality results.
At first glance, choosing the lowest-cost provider may seem like a smart move. But time and again, that decision leads to hidden costs, delays, and patient risks.
The Hidden Cost of Poor Quality in Clinical Trials
At Ancillare, we’ve seen it firsthand. Sponsors who select vendors based solely on the upfront price often end up spending twice as much correcting quality-related issues, including:
- Regulatory delays
- Non-compliant packaging
- Temperature excursions
- Missed or late shipments
This mirrors industry-wide findings. The American Society for Quality reports that poor quality can account for 15-40% of total business costs, much of it hidden in rework, delays, and noncompliance. (ASQ, Cost of Quality)
Poor quality in ancillary supply management affects more than logistics. It creates cascading problems throughout the clinical trial, from protocol deviations to missed shipments. But the most serious risk is to patients. Without oversight from subject matter experts in global regulatory compliance, medical, and quality assurance, there is a real possibility that patients may receive incorrect, delayed, or compromised supplies. These breakdowns can jeopardize patient safety, impact outcomes, and erode trust in the trial itself. The cost is not only financial — it is human.
What Is the Cost of Quality (CoQ) in Clinical Trials?
The Cost of Quality (CoQ) includes all the expenses an organization incurs to achieve and maintain the required level of quality. Understanding CoQ is crucial for Sponsors managing clinical trial supply chains because they extend far beyond simple inspections or compliance checks.
CoQ is traditionally divided into four key categories:
Prevention Costs:
These are investments made to avoid defects before they occur. Examples include staff training, process design and validation, quality planning, and maintaining a strong Quality Management System (QMS). Prevention reduces the likelihood of costly failures downstream.
Appraisal Costs:
These costs involve measuring and monitoring activities such as inspections, audits, and testing. They help detect defects early in the process before they reach clinical sites.
Internal Failure Costs:
These arise from errors identified before delivery, including rework, wasted materials, delays, and additional labor required to fix issues before the product reaches its destination.
External Failure Costs:
These are the most damaging costs incurred when defects are discovered after delivery. They include site dissatisfaction, protocol deviations, regulatory noncompliance, reputational harm, and sometimes financial penalties.
Many Sponsors underestimate these costs since some, especially failure costs, are hidden or indirect. However, failing to invest adequately in prevention and appraisal often leads to greater internal and external failure costs, threatening trial timelines, budgets, and overall trial success.
How Quality Failures Impact Patients and Outcomes
When ancillary supply chains break down, the impact is not only financial. Quality failures can lead to:
- Missed patient doses
- Delayed or interrupted care
- Participation setbacks
- Compromised trial integrity
Ultimately, the patient bears the consequences of supply chain gaps, making quality not just a compliance issue, but an ethical responsibility.
Why the Right Partner Matters in Ancillary Supply Management
Quality is not just a checkbox — it’s a critical factor in controlling costs, ensuring compliance, and protecting patients.
Ancillare’s fully integrated model embeds quality and regulatory oversight into every stage of the clinical trial supply chain. Our global Quality Management System (QMS) is designed for the complexity of multinational studies, helping Sponsors avoid costly setbacks.
With centralized oversight and harmonized processes, Ancillare helps Sponsors:
- Streamline planning and sourcing from the start
- Ensure compliance in kitting, packaging, and labeling
- Maintain full traceability during global distribution
- Meet storage and temperature controls requirements
- Support reconciliation and reclamation
By combining global infrastructure with deep quality and regulatory expertise, Ancillare prevent errors that compromise clinical trial timelines and patient safety.
Quality Is a Strategic Investment, Not an Expense
For clinical trial Sponsors, quality is not optional, it is a strategy investment. It protects patients, safeguards timelines, and enhances trial integrity.
At Ancillare, quality is built in from the start; not managed after the fact. From protocol analysis to site delivery to final reclamation, we reduce complexity and risk while supporting speed, compliance, and cost control.
When evaluating partners, the question is not only what a service costs, but what it could cost if quality is compromised.
Partner with Ancillare for Quality in Clinical Trial Supply Chain Management
Contact Ancillare to discover how we can help you manage your clinical trial ancillary supplies with the quality, oversight, and consistency your trial — and your patients — deserve.
