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Ancillary Kitting: More than Just Packing Boxes

Ancillary Kitting: More than Just Packing Boxes

Sep 19, 2025 | Articles, Featured

Some Sponsors assume they can cut costs or gain flexibility by shipping ancillary supplies in bulk to investigator sites. While this may seem efficient, ancillary kitting is far more than a logistical task. It is a strategic function that directly impacts patient safety, data quality, and regulatory compliance.

When sites are left to pull supplies from bulk inventory for each patient visit, Sponsors risk delays, inconsistencies, and quality failures that can compromise trial timelines and outcomes. Without centralized expertise and infrastructure, “hunting and gathering” becomes a source of risk rather than a point of control.

Here’s why relying on sites to source ancillary supplies directly is not a best practice.

 

Kitting Is a Strategy, Not a Packing Task

Effective ancillary kitting begins long before any items are packed. It involves upstream protocol alignment, global regulatory knowledge, and precise inventory planning and end-to-end supply chain coordination.

This complexity demands more than a logistics vendor. It requires a partner with the infrastructure and expertise to execute kitting with accuracy and reliability.

A qualified ancillary kitting partner must be:

  1. GxP compliant, with established SOPs and ongoing quality audits
  2. Built for operational excellence and packaging integrity
  3. Experienced in country-specific import regulations and labeling standards

Ancillare meets all these requirements. Our regulatory and quality collaborate with Sponsors to ensure every kit meets trial- and country-specific requirements, reducing the risk of delays, noncompliance, and site burden.

Why Site-Assembled Kits Create More Risk Than Reward

When Sponsors ship bulk supplies to clinical sites for local assembly, they introduce uncontrolled variables that can derail the trial. Most clinical sites are not equipped or staffed to handle kit assembly onsite with the oversight and compliance required.

Common risks of site-assembled kits include:

  • Increased workload for site employees, distracting from patient care
  • Kit content variations that lead to protocol deviations
  • Improper storage or inventory handling, including expired supplies
  • Customs delays and rejections due to inaccurate documentation
  • Lack of visibility and tracking once supplies leave the Sponsor

What appears to be a flexible or cost-saving solution often leads to inefficiencies, compliance issues, and increased patient risk.

Strategic Kitting Begins with Purposeful Design

True strategic kitting aligns directly with protocol requirements, enrollment forecasts, and site-specific needs. At Ancillare, we bring structure and predictability to the process with:

  • Protocol-driven kit configurations, customized by region or visit
  • Demand planning based on real-time enrollment and usage data
  • Centralized inventory with GDP-compliant storage
  • On-demand kitting to support resupply or urgent site needs
  • Expert supply selection through our Medical Supply Consulting team
  • Global network and specialized teams versed in country-specific requirements

While one box might seem like it can hold everything, many items require unique handling or packaging, and not all supplies are compatible. Expiration tracking must also be carefully managed.

This integrated approach ensures that clinical sites receive the right supplies at the right time for the right patient — reducing waste, avoiding shortages, and eliminating overages.

Custom Ancillary Kits Built to Protocol, Not Pre-Packaged

No two clinical trials are alike, and neither are their ancillary supply needs. Ancillare designs and assembles fully customized ancillary kits tailored to protocol requirements, regional regulations, and patient visits.

We manage the full kit production and distribution process, leveraging our unmatched global network to deliver with speed, accuracy, and compliance. Our teams monitor both regional and global trends to help Sponsors anticipate challenges and build resilience into their supply plans.

By aligning each kit to the patient journey — not just a supply list — we ensure that clinical sites receive exactly what they need, when they need it, without unnecessary burden or waste.

Ancillare supports a wide range of kit types, including:

  • Ancillary Trial Kits
  • Blood Collection Kits
  • Nursing Kits
  • Patient Supply Kits
  • Site Support Kits
  • Lab Kits for Specimen Collection

As your single-source partner, we work collaboratively to implement flexible, scalable solutions — simplifying the complexity of clinical trial supply while increasing site efficiency and Sponsor confidence.

Kitting with Ancillare: A Strategic Advantage

Ancillary kitting is not a background task; it is a strategic component that can advance or delay your clinical trial. When done right, it brings clarity, consistency, and control to a complex global supply chain.

Working with Ancillare makes it easy to alleviate site burden through expertly sourced and assembled kits, built to your exact specifications and designed to support every aspect of the patient’s journey.

Ancillare is more than a service provider. We are a strategic partner, purpose-built to support Sponsors and CROs across the full clinical trial supply chain. Our kitting solutions are compliant, customizable, and aligned for global execution to help Sponsors move faster, reduce risk, and stay focused on clinical trial success

Ready to Elevate your Ancillary Kitting Strategy?

Partner with Ancillare to streamline trial execution and gain control over one of the most overlooked — yet critical — components of the clinical trial supply chain.
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The Hidden Cost of Quality in Clinical Trials and Why Choosing the Right Partner Pays Off

The Hidden Cost of Quality in Clinical Trials and Why Choosing the Right Partner Pays Off

Aug 19, 2025 | Articles, Featured

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. 

 

Clinical Trials Insights 2021 – Stay Ahead of the Supply Chain

Clinical Trials Insights 2021 – Stay Ahead of the Supply Chain

Jan 17, 2022 | Articles, Featured, Industry Publications

A lack of correct ancillary supplies can be the difference between a clinical trial starting on time or having to delay at significant cost to the sponsor. The Covid-19 pandemic exacerbated what would already be a difficult task of sourcing and purchasing trial equipment. Ancillare CEO Joanne Santomauro explains how the situation developed and how her company stayed ahead of the curve and minimised the impact of shortages in the supply chain.

As published in Clinical Trials Insight 2021

VIEW THE ARTICLE
The Drivers of Success in Ancillary Supply Chain Management

The Drivers of Success in Ancillary Supply Chain Management

Feb 24, 2020 | Featured, White Papers

With an emerging Clinical Trial Ancillary Supply Chain™, and little research into effective management models, it has never been more urgent for management systems to step up to an increasingly complex trial landscape. Today’s pharmaceutical landscape relies increasingly on outsourcing efforts. Meanwhile, global rules, laws, and regulations continue to evolve at a rapid pace, and pressure to expedite market approvals for new drugs mounts. Due to the intertwined factors, a new, extremely complex global ‘ancillary’ supply chain has emerged. In this era of change, how does the ancillary supply chain respond to the needs of a rapidly changing industry and create better outcomes for drug discovery organisations and their patients?

As published in International Clinical Trials Journal

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