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Ventura, California - SanaClis, a leading global clinical research organization (CRO), and a prominent provider of clinical trial supply...
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The Hidden Cost of Clinical Delays
6 minute read
Delays in clinical trials are costly, both financially and strategically—but many of them are preventable.
SanaClis’ integrated clinical supply chain model eliminates the inefficiencies of fragmented vendors, ensuring
smooth planning, real-time visibility, and faster execution. In addition to being a full-service global CRO, the
company offers a full spectrum of solutions that keep trials on track, from Qualified Person (QP) services and
customs brokerage to direct-to-patient delivery. With proven reliability, financial stability, and a focus on proactive
planning, SanaClis turns supply chain readiness into a strategic advantage for sponsors of all sizes.
Introduction
In clinical development, time is money. Every additional month a trial remains open can cost a sponsor millions of
dollars, not just in operational expenses but in lost market opportunity, delayed revenue, and diminished competitive
advantage. For emerging biotechs, the stakes are even higher. Extended timelines can jeopardize investor
confidence or the ability to secure the funding needed to keep programs moving forward.
Despite these realities, supply chain readiness is often treated as an afterthought, addressed reactively rather than
strategically. This oversight can create costly bottlenecks — delayed site activations, product shortages, or
regulatory hold-ups — that ripple through a study’s timeline.
Forward-thinking sponsors are changing that paradigm. By treating the clinical supply chain as a critical driver of
study success rather than a support function, they are building in the resilience and agility needed to keep trials on
track. With integrated planning, real-time visibility, and expert guidance, a well-prepared supply chain doesn’t just
prevent delays; it actively accelerates development, reduces costs, and positions promising therapies to reach
patients sooner.
The Cost of Delays
Delays in clinical development are more than just operational setbacks; they are strategic risks with significant
financial and clinical consequences. For emerging biotechs, the impact is even sharper. A delay in first-patient-in
or a mid-study bottleneck can undermine investor confidence or slow the funding needed to advance a program.
Even when the science is strong, sponsors without the operational support to keep studies on schedule may find
themselves struggling to maintain momentum in a highly competitive landscape.
The cost is not only financial. Timely execution is often tied to patient outcomes, especially in rare disease or
oncology trials where every delay can mean slower access to potentially lifesaving treatments. The cumulative
effect of these delays underscores why a reactive approach to supply chain planning is no longer acceptable. By
building readiness into the earliest phases of development, sponsors can mitigate risk, improve predictability, and
keep their programs moving forward without unnecessary disruption.
Integrated Supply Chain Advantage
The clinical supply chain is often viewed as a back-end operational task, but in reality, it is one of the most critical
levers for ensuring speed, quality, and predictability in a study. When planning, logistics, and distribution are siloed
or outsourced to multiple vendors, communication gaps and delays are almost inevitable. As a full-service global
clinical research organization (CRO), SanaClis addresses this challenge with an integrated, end-to-end model that
keeps every aspect of the supply chain under one roof and closely aligned with the clinical operations team.
By owning its supply chain infrastructure, including depots, packaging and labeling operations, and regulatory
expertise, SanaClis eliminates the disconnects that can slow a trial before it even begins. This integration creates
a single point of accountability, enabling faster decision-making and tighter coordination between the teams
responsible for study start-up, site activation, and ongoing distribution. The result is a streamlined process where
operational planning and logistics work hand in hand, reducing the risk of missed milestones or product
unavailability at critical points. Beyond core logistics, SanaClis provides Qualified Person (QP) release, customs
brokerage, and direct-to-patient delivery, ensuring that even the most complex supply requirements are handled
with speed and compliance.
This model also provides sponsors with something equally valuable: confidence. With full visibility into inventory,
shipments, and timelines, sponsors know exactly where their materials are and can make informed, real-time
decisions when adjustments are needed. For biotechs operating with lean teams, that kind of transparency and
predictability can make the difference between a study that stays on schedule and one that drifts off course.
Speed in Action: Case Studies
The value of a well-integrated, data-driven supply chain becomes clear when you look at how it performs under
real-world conditions. Time and again, SanaClis’ approach has turned what could have been major delays into
examples of accelerated execution.
One striking example involved a sponsor preparing for a global trial that required multiple Qualified Person (QP)
audits in the United States. A competitor projected that completing the necessary audits across eight facilities would
take approximately nine months, delaying the start of the trial by more than half a year. By leveraging its in-house
expertise and network of experienced QPs, SanaClis reduced that timeline to just three weeks, compressing a
critical bottleneck and enabling the sponsor to begin dosing on schedule.
Similar advantages show up in study start-up timelines. Where many organizations plan for a 12-month window to
initiate sites, SanaClis typically completes this process in closer to six months. That acceleration doesn’t just shorten
the path to first-patient-in; it can also mean earlier data collection, faster decision-making for subsequent phases,
and the potential to reach regulatory milestones ahead of plan.
These efficiencies are not isolated achievements but the result of systems and processes designed to align every
part of the trial’s operational framework. By keeping critical functions connected and anticipating challenges before
they create roadblocks, SanaClis helps sponsors achieve timelines that many in the industry view as aspirational
without compromising on quality or compliance.
SIMS and Data-Driven Planning
Visibility and precision are the foundation of a reliable clinical supply chain. SanaClis’ proprietary Supply Inventory
Management System (SIMS) was developed to provide both, giving sponsors a real-time view of their inventory
and shipments across the globe. Rather than relying on manual updates or disjointed vendor reports, SIMS creates
a unified platform where every stakeholder — clinical teams, supply chain managers, and sponsor representatives
— can see the same data, updated in real time.
This level of transparency transforms how sponsors plan and execute their studies. By combining current inventory
data with demand forecasts, SIMS enables proactive decision-making that reduces both risk and waste. Sponsors
can plan replenishments with confidence, avoid costly overproduction or understocking, and respond quickly when
enrollment patterns shift or sites require additional support.
The platform also supports scenario planning, allowing teams to model the impact of potential changes, such as
adding new sites, adjusting dosing schedules, or expanding to additional countries, before those changes create
logistical challenges. This predictive capability is particularly valuable for emerging biotechs, where even small
missteps in supply planning can have outsized financial and operational consequences.
By embedding data-driven planning into every stage of the trial, SIMS turns supply chain management from a
reactive task into a strategic advantage, ensuring that materials are where they need to be, when they need to be
there, without the inefficiencies and guesswork that so often lead to delays.
Lean Overhead, High Value
In an industry where operational excellence often comes at a premium, SanaClis has built a model that delivers
both quality and value. By maintaining lean organizational overhead and avoiding unnecessary layers of
bureaucracy, the company can offer pricing that is competitive without sacrificing the depth of expertise or the level
of service that sponsors expect. This efficiency is particularly meaningful for emerging biotechs, where budgets are
tight and every dollar must demonstrate impact.
What sets this model apart is its long-term perspective. Rather than optimizing for short-term gains or margins,
SanaClis focuses on building enduring partnerships. Supporting a small, early-stage trial may not be the most
lucrative engagement on its own, but it creates the foundation for a relationship that can grow as the sponsor’s
pipeline matures and expands. Over time, that trust and continuity translate into operational efficiencies and
smoother collaboration, benefitting both the sponsor and the patients waiting for innovative therapies.
By combining cost efficiency with consistently high-quality execution, SanaClis ensures that sponsors of all sizes
— whether preparing for a first-in-human study or managing a global phase III program — can access the level of
support they need without compromise. That balance of performance and reliability is reinforced by its AAA credit
rating and CDISC Gold membership, independent validations of the company’s financial stability and commitment
to global quality standards.
Continuity Builds Efficiency
True efficiency in clinical development comes from the stability of the team behind the program. High turnover rates,
common across the CRO landscape, can disrupt studies, slow timelines, and erode the trust that’s essential to
productive collaboration. SanaClis has taken a different path, fostering a culture that prioritizes employee retention
and engagement. With an annual turnover rate of roughly 5%, the company maintains a level of continuity that few
competitors can match.
This stability pays dividends for sponsors. The teams that launch a study are often the same ones that guide it
through completion, carrying forward critical knowledge about the program, its challenges, and its nuances. There’s
no repeated learning curve, no time lost in onboarding new personnel, and no risk of errors caused by
miscommunication between transitioning team members. For multi-year or multi-phase programs, this consistency
becomes a powerful advantage, enabling smoother execution and more confident planning.
Continuity also strengthens relationships. Sponsors build familiarity with their points of contact and gain confidence
that the people they rely on truly understand their priorities and expectations. That sense of partnership, reinforced
by steady operational performance, creates an environment where collaboration thrives and studies move forward
with fewer disruptions.
By investing in its people and maintaining a structure that supports both quality of work and quality of life, SanaClis
ensures that sponsors experience the full benefit of a committed, experienced team from first-patient-in to database
lock and often well beyond, as programs advance and partnerships deepen.
Conclusion
Delays in clinical development are costly in every sense: financially, strategically, and critically for patients waiting
for new therapies. Yet many of these delays stem from a common source: a supply chain that wasn’t ready when it
needed to be. Treating logistics as an afterthought leaves sponsors reacting to problems instead of preventing
them, often at the expense of both time and resources.
By making supply chain readiness a strategic priority, sponsors can transform one of the most common sources of
trial disruption into a driver of speed, efficiency, and confidence. SanaClis has built its model around this principle,
integrating supply chain expertise with clinical operations to deliver a seamless, end-to-end approach. The result is
a system where potential bottlenecks are anticipated and resolved before they become barriers, where real-time
visibility allows for rapid adjustments, and where every decision is guided by a clear view of its operational impact.
For emerging biotechs, this means staying on schedule and on budget while focusing internal resources on science
and strategy rather than logistics firefighting. For larger organizations, it means reducing risk and ensuring that
global programs progress with the predictability and precision that regulators, investors, and patients demand.
In clinical research, readiness is more than preparation — it’s a competitive advantage. By building that readiness
into the foundation of every trial, sponsors can accelerate development, control costs, and, most importantly, bring
promising therapies to the patients who need them faster.
