Articles - Ancillare, LP

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:

GxP compliant, with established SOPs and ongoing quality audits
Built for operational excellence and packaging integrity
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.

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.

Why Investigator Sites Shouldn’t Order Ancillary Supplies: Uncovering the Hidden Risks that Could Derail Your Clinical Trial

Apr 16, 2025 | Articles

Risks of Investigator-Managed Supplies

Clinical teams in pharma and biotech often look for ways to optimize budgets and streamline operations. One approach that may seem efficient is allowing investigator sites to order their own ancillary supplies for clinical trials. While it may appear to offer greater flexibility and control, this decentralized model introduces hidden risks in clinical trial supply chain management, such as including increased costs, regulatory risks, and operational inefficiencies.

Lack of Standardization

When investigator sites source their own ancillary supplies and equipment, it creates inconsistencies in product quality, regulatory compliance, and compatibility across sites. These discrepancies compromise study integrity and patient safety, which are critical aspects of regulatory compliance in clinical trials.

Higher Costs, Not Savings

It may seem cost-effective to shift ancillary supply management to sites, but it often leads to higher overall expenses due to:

Paying higher per-unit costs due to non-bulk purchasing
Missing supplier discounts compared to centralized procurement
Adding administrative burden on sites

Rush orders alone can cost up to 50% more than standard procurement, according to industry data. By contrast, centralized procurement strategies use economies of scale and supplier negotiations to lower costs and improve financial efficiency across the clinical trial supply chain.

Regulatory and Compliance Risks

Allowing investigator sites to independently manage ancillary supplies increases the risk of using non-compliant or unvalidated products. This can lead to protocol deviations, audit findings, and delays in regulatory approvals. Effective clinical trial risk management becomes much harder to maintain with decentralized procurement.

Recent FDA Form 483s from 2024 cited sites for poorly maintained equipment, missing calibration records, and failure to follow sponsor protocols. These issues could have been avoided with centralized quality control. Poor site-level burden management in this area can significantly delay trial timelines.

Logistical and Supply Chain Issues

Centralized procurement streamlines clinical trial logistics, inventory tracking, and supplier accountability. When sites handle purchasing non-IMP supplies, there’s a higher likelihood of stockouts, shipment delays, and supply mismatches, impacting trial timelines and data integrity. A strategic approach to clinical trial solutions ensures that the supply chain runs smoothly, mitigating these risks.

Improper Equipment Management

Most sites lack the resources to handle the full lifecycle of clinical trial equipment, including calibration, maintenance, and end-of-trial disposition. Without centralized oversight from a partner, trials risk delays, noncompliance, and increased costs due to improper equipment management.

Complicated Inventory Management

Effective inventory tracking and replenishment require specialized systems and oversight that many sites lack. Poor inventory management can lead to stock shortages, expired supplies, and inefficiencies that delay trials.

Burden on Investigator Sites

Asking sites to handle procurement adds unnecessary stress to already overburdened staff, increasing the risk of mistakes and delays. This can negatively impact site satisfaction and retention, ultimately hindering the success of your trial.

Negative Impact on Sustainability

When sites independently order ancillary supplies, inefficient ordering, increased packaging waste, excess inventory, and redundant shipments contribute to unnecessary carbon emissions and environmental waste. Centralized procurement allows for optimized shipping, reduced packaging, and better resource allocation, supporting sustainability goals.

Compromised Patient Safety

Improper supply management can directly affect patient safety. Issues like expired products or supply shortages can lead to adverse events or delays in treatment, impacting both patient health and trial integrity.

A Smarter Approach to Ancillary Supply Management

Instead of pushing procurement to individual sites, clinical teams should partner with a full-service provider that manages ancillary supply management from trial start-up through closeout. A global, strategic partner helps sponsors reduce site burden and deliver high-quality, cost-effective solutions for every aspect of the clinical trial supply chain.

A global partner can:

Reduce costs through economies of scale and supplier negotiations
Ensure regulatory compliance in clinical trials and product standardization
Streamline logistics and inventory tracking
Manage equipment calibration, maintenance, and reclamation
Support sites by allowing them to focus on patient recruitment, enrollment, and care
Advance sustainability goals through smarter supply management

Having clinical sites manage their own ancillary supplies, equipment, and medical devices does not optimize your clinical trial supply chain management. In an industry where precision, compliance, and patient safety are critical, decentralized ancillary supply management introduces unnecessary risks and headaches. A dedicated partner ensures streamlined operations, regulatory compliance, and cost efficiency.

Ready to simplify your clinical supply chain and protect your clinical trial’s success? Let’s talk.

References

Counting the Ways Supply Chain Inefficiencies Impact Patient Care, Medical Design & Outsourcing. Read
FDA Form 483 Observations, 2024. U.S. Food and Drug Administration. FDA.gov

Clinical Trial Supply and Logistics Supplement: Quality assurance and regulatory compliance, and ancillary supply chain management

Aug 30, 2024 | Articles, Industry Publications

The evolution of the clinical trial ancillary supply chain (CTASC), the globalisation and expansion of clinical trials in the most difficult regions of the world, and the requirement for better, faster and leaner methods, have presented a myriad of unforeseen and unprecedented risks and challenges for the CTASC organisation. The CTASC professional must possess the ability to research, evaluate, execute and guarantee that all components and all links in the chain align to achieve success.

As published in International Clinical Trials: Clinical Trial Supply and Logistics Supplement

VIEW THE ARTICLE

To Research Faster, You Need an Ancillary Partner Who Reaches Further

Jul 30, 2024 | Articles

Bringing innovative therapies to the market involves more than sound science. It requires operational excellence in every step of the clinical trial journey to raise the probability of success.

Every clinical trial is unique. From protocol to therapeutic specialty to patient nativity, each trial has specific and unique needs. However, every clinical trial shares a common characteristic: the dependency on well planned processes to deliver on-time and on-budget studies.

At Ancillare, we develop leading global programs to manage the ancillary supplies that are critical to how far a clinical trial can progress and how fast it gets there.

Like IPs, Ancillary Delays Derail Clinical Research

Ancillare–the leader in ancillary supplies and equipment management programs–calculates that Sponsors could achieve over 30% in cost savings by optimizing how they manage their trial’s ancillaries.

Sponsors spend a lot of energy and resources coordinating the efficient sourcing and regulatory requirements of the clinical side of the trial.

However, the truth of trials is that both a biosimilar and a portable refrigerator can bring a clinical trial to a halt. And send budgets and timelines spiraling.

Even minor oversights in ancillary supplies can prevent or delay revolutionary therapies from reaching the patients they were developed to help.

Trials truly built to accelerate research and expand global treatment delivery demand expert management of every detail of the trial process. And the most significant of the overlooked details is often ancillary supplies and equipment.

There Are No Small Parts in Clinical Trials

Clinical trials require the alignment of many moving parts. If one of them stops, two things tend to happen: timelines extend and costs rise.

Ancillary supplies and equipment programs provide an excellent illustration of how Sponsors can lose time and money by leaving some components of their trials unattended, or poorly planned and managed.

Supply Chain Gaps Cost Sponsors Millions

Ancillaries–every non-drug item needed to execute a trial–represent about 4.2% of a clinical trial’s cost. On average that means anywhere from $168k-$840k at the outset of the trial. May not sound like a significant upfront line item, but a lack of management and subsequent delays cost upwards of $600k/per day (with estimates as high as $8MM).

Managing ancillaries requires skills that demand extraordinary levels of competence in logistical coordination, sourcing, transnational relationships, risk and project management.

Sponsors and CROs rightly spend the majority of their supply chain focus on the IP itself. But without a specialized skill set around ancillaries and equipment, they end up paying higher prices for ancillary items and incurring increased freight, storage, reclamation, and disposition expenses. Compounded upon that is the constant juggling of regulatory and coordination intricacies that require import/export expertise and on-the-ground experience in the countries and at the sites where trials are being conducted.

Together, these gaps and inefficiencies lead to delays, significant increases in goods and equipment costs, and additional management fees to handle rush issues. Sponsors and CROs can quickly see budgets and timelines spiral out of control.

Prevention’s Power: Reach Further and Research Faster

Ancillare has dedicated the last 17 years to making clinical trials happen in over 100 countries – collaborating with Sponsors to address and relieve their unique pain points while developing tailored plans that acknowledge prevention as the best medicine.

Ancillare’s work is grounded in partnership. Not just with the Sponsors who trust us with their trials’ ancillary supply and equipment programs, but also across the globe and throughout our extensive strategic depot network. The difference maker for Sponsors and CROs alike is our hands-on approach in both the planning and the operational execution of their programs.

Our full service partnerships include:

Protocol analysis to anticipate supply and equipment needs.
Medical consulting to mitigate risk of item availability and/or regulatory issues.
Single-source model with 22 strategic global depots.
Import/export management facilitating trials’ requisitions.
Returns, reclamation, and disposition services to support closeout requirements.

Ancillary supply and equipment programs are a strategic investment, not an expense. Taking a patchwork, ad hoc approach, or figuring things out along the way, can and will result in hidden costs and vital days lost for patients’ access to life-improving treatments.

Schedule a consultation today, and let’s keep your research moving forward.

Know + Know How: Reengineering Consultative Partnerships in CTASC™ Management

Feb 1, 2022 | Articles

Today’s clinical research environment requires cooperation and insight across countless organizations, teams, and specialists. More and more, Sponsors are turning to trusted third parties with high levels of expertise to make their trials run effectively.

Collaboration often develops into long-term partnerships, which can produce tremendous value. On the other hand, mismanaged partnerships can also spur frustration and dead ends. A common example is the consultative exchange, which often leaves Sponsors with a wealth of advice — but no path to implementation. Without the operational means to execute the strategy, they are back to square one.

The Strategy to Success

To make the most of consulting engagements, Sponsors should aim to partner with teams that not only demonstrate specialized knowledge, but also the ability to put their own advice into action. The difference between the two can be difficult to spot — but probing for anecdotal examples gives tremendous insight. It is always worth the time to ask prospective partners about the types of challenges they have been brought in to solve, and the specific steps they take to arrive at solutions.

Another indicator of an implementation-oriented partner is use of technology. Whether looking at companies of larger scale who offer full clinical trial management systems, or smaller teams with specialized programs and solutions, Sponsors will benefit far more with robust technologies at their fingertips.

Nuances of Clinical Supply Chain Management

Some aspects of conducting clinical research benefit from highly specialized support. Sourcing and managing ancillary supplies for clinical trials is a prime example. There are countless approaches to outsourcing ancillary supply and equipment management, but some will only place greater burden on the Sponsor when all is said and done.

Ancillare developed the Clinical Trial Ancillary Supply Chain (CTASC™) approach for precisely that reason. While Sponsors need to make informed decisions about their clinical supply chains, they also need support to innovate along the way. The consulting component of CTASC is an invaluable resource for Sponsor teams, particularly in the planning and start-up phases. It bolsters risk management in clinical trials, and ensures that protocol considerations do not take a backseat.

Sponsors can also choose to turn over their ancillary supply chain management entirely, reaping the benefits of an end-to-end solution. A fully managed CTASC means no loose ends after the engagement comes to a close — everything is handled, all the way through to returns, reclamation, and disposition.

CTASC™: a Holistic Solution

Ancillare is reimagining what consultative partnerships in clinical research can be. CTASC makes supply chain expertise practical, with hands-on support to bring entire strategies to fruition. Our engagements are flexible, and we work closely with Sponsors to address and relieve unique pain points. To find out how Ancillare can support your team, contact us today.

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