Clinical development can be a challenging and resource-intensive process for small and emerging biotechs. These
companies often run lean, with just a handful of people available to manage complex clinical operations, navigate
regulatory hurdles, and keep investors confident in their progress. Timelines are tight, budgets are limited, and the
stakes could not be higher. Any delay in starting a study, enrolling patients, or generating data can jeopardize not
only a development program but the company’s ability to secure the next round of funding.
The right clinical research organization (CRO) partner can make the difference between momentum and frustration.
SanaClis has built its reputation on meeting biotechs where they are — delivering flexible, fit-for-purpose solutions
that scale with the sponsor’s needs. Founded in Central and Eastern Europe more than two decades ago, SanaClis
has grown thoughtfully into a truly global CRO, bringing its high-touch approach to sponsors across the globe. By
combining the reach and expertise of a full-service CRO with an integrated clinical supply chain and the agility of a
boutique organization, SanaClis helps emerging companies advance their programs without the burden of rigid,
one-size-fits-all processes, while also supporting large pharmaceutical sponsors through targeted functional
services.
The result is a partnership model that is as adaptable as the biotech it supports: streamlined enough to deliver
speed and efficiency in early-stage programs, yet robust enough to grow alongside a sponsor as their pipeline
matures and expands globally. This is the essence of “right-sized support for right-sized sponsors” — tailored
services that allow smaller organizations to compete with the same confidence and operational rigor as much larger
players.
Flexibility as a Competitive Advantage
For many biotechs, partnering with a CRO can feel like trying to fit a square peg into a round hole. Large, process-
heavy CROs often impose rigid systems that are better suited to the structured environments of major
pharmaceutical companies, leaving emerging sponsors struggling to adapt. SanaClis takes a fundamentally
different approach. Its operating model is built on the principle that no two sponsors are alike, and its services are
tailored accordingly, whether a company needs focused functional support or a fully outsourced solution.
With more than 3,600 clinical projects successfully delivered as a functional and full-service provider, SanaClis has
demonstrated that flexibility and scalability are not mutually exclusive, whether serving a lean virtual biotech or a
global pharmaceutical leader. This flexibility starts with understanding where a sponsor is in its development
journey. Early-stage or virtual biotechs, often without internal clinical teams, may need end-to-end execution
support. In those cases, SanaClis effectively operates as an extension of the sponsor’s team, managing everything
from trial design and regulatory submissions to site activation, patient recruitment, and data management. Sponsors
benefit from seamless execution without having to rapidly build infrastructure or hire specialized staff.
On the other end of the spectrum, larger biopharma companies often require targeted functional services to
augment their internal capabilities. SanaClis adapts to those needs as well, offering specialized expertise in areas
such as regulatory affairs or biostatistics to complement an existing team. At the same time, clinical supply chain
management is a fully integrated core capability that ensures seamless alignment between operations, logistics,
and trial execution. This integrated strength, combined with functional expertise, applies across geographies and
therapeutic areas, allowing sponsors to engage at the level of support that makes the most sense for their program
and their organization.
Equally important, the partnership does not end when a study closes. SanaClis is structured to scale with its clients
as they progress from early proof-of-concept trials to multi-country phase II and III programs. Processes, systems,
and dedicated staff expand in step with the sponsor’s needs, maintaining continuity and institutional knowledge that
speed execution and reduce operational risk. This ability to grow alongside a sponsor — without forcing them to
change vendors or reestablish trust — is a major advantage for companies that aspire to take their programs global.
Integrated Services Under One Roof
Clinical development involves a web of interconnected functions: clinical operations, regulatory compliance,
biostatistics, data management, and supply chain management, among others. In many organizations, these
elements are handled by a patchwork of vendors, each with its own processes, systems, and communication styles.
While this approach may seem efficient on paper, it often introduces friction, delays, and unnecessary costs as
teams struggle to stay aligned.
SanaClis takes a different path, keeping all critical clinical trial services under one roof. From protocol planning and
site selection to data analysis and logistics, the company’s core teams work in close coordination from the earliest
stages of a program through study completion. This integrated structure eliminates the silos that can slow progress
and ensures that every function is aligned on the same objectives, timelines, and quality standards. This model has
supported the seamless execution of more than 335,000 clinical shipments worldwide, ensuring consistent quality
and timelines across complex programs.
The benefits of this model are tangible. When clinical operations and supply chain teams collaborate daily, for
example, site activations can be paired with the timely delivery of investigational products and kits, preventing the
bottlenecks that can delay first-patient-in. Likewise, in-house data management and biostatistics teams can rapidly
provide insights to inform protocol amendments or adaptive design decisions, reducing turnaround times that might
take weeks or months in a multi-vendor environment.
For sponsors, this translates into a smoother, faster, and more predictable execution process. There is a single
point of accountability, fewer handoffs, and a unified project team that truly understands the nuances of the program.
This not only accelerates timelines but also gives sponsors greater confidence that their studies are being managed
cohesively, with full visibility into progress and challenges at every step.
Agility and Quality
In an industry where timelines are tight and the cost of delay is steep, speed alone is not enough; that speed must
come paired with quality and reliability. SanaClis has refined an operating model that delivers both. Nearly 95% of
its full-service projects are completed ahead of schedule, giving sponsors the dual advantage of faster data
generation and reduced operational costs and reflecting both operational strength and a commitment to client
success. For early-stage companies, that acceleration can mean a critical edge in securing funding or advancing
to the next phase of development. For larger organizations, it helps align clinical timelines with strategic and
commercial goals.
One of the keys to this consistent performance is SanaClis’ lean, focused team structure. Unlike larger CROs that
often overload their clinical research associates or project managers with multiple concurrent studies, SanaClis
deliberately manages workloads to preserve attention, quality, and morale. This approach not only reduces the risk
of burnout but also fosters a culture of accountability and ownership, where team members can devote the
necessary focus to each program.
Equally important is the stability of the team itself. With an annual staff turnover of only about 5%, SanaClis
maintains a level of continuity that is rare in the industry. The same professionals who launch a study are often the
ones guiding it through completion, carrying forward institutional knowledge that helps avoid repeated learning
curves and ensures smoother execution. This consistency also builds trust and familiarity with sponsors, creating
partnerships that feel less transactional and more collaborative over the long term.
This combination of agility and quality is not a coincidence. It is the result of intentional choices about structure,
culture, and process. By balancing efficiency with care and by valuing both speed and stability, SanaClis provides
sponsors with the confidence that their programs are in experienced, focused hands from first planning discussions
to final database lock.
Bridging Biotech and Big Pharma Standards
As the company expanded from its roots in Central and Eastern Europe to develop a global footprint expanding into
Western Europe and the United States, it has maintained the balance of rigorous systems and the personalized
approach that early clients valued, ensuring smooth collaboration across geographies and company sizes. One of
the challenges for emerging sponsors is finding a partner that understands the rigor and compliance expectations
of larger pharmaceutical organizations while still providing the agility and attention that smaller companies need.
SanaClis bridges that divide with systems, infrastructure, and expertise designed to meet the most stringent global
standards without sacrificing the flexibility that makes its model so effective for leaner teams.
From IT architecture and cybersecurity protocols to quality management systems and regulatory compliance
frameworks, SanaClis operates at a level that satisfies even the most complex requirements of multinational
pharmaceutical companies. Sophisticated electronic quality management systems (EQMS), secure data
environments, and validated platforms for study planning and documentation provide the assurance that every
process meets international regulatory and data protection standards.
At the same time, the organization retains the responsiveness and high-touch service that smaller sponsors value.
This dual capability allows SanaClis to support a virtual biotech’s first-in-human trial with the same level of rigor it
applies to global phase III studies for larger clients. As those smaller sponsors grow, they don’t need to seek out
new partners or undergo disruptive transitions; the same trusted team can scale seamlessly with their expanding
portfolio and geographic reach.
This balance of big pharma-grade infrastructure with boutique-level adaptability has become a defining strength. It
positions SanaClis as a partner that can deliver operational excellence at any scale, enabling emerging biotechs to
compete and collaborate on equal footing with much larger players in the global clinical research landscape.
Proof in Performance
Strong claims of flexibility, quality, and speed mean little without results to back them up, and this is where SanaClis
consistently distinguishes itself. The company’s track record of delivery ahead of schedule is more than a statistic;
it reflects a finely tuned operational model designed to anticipate challenges, align teams, and keep studies on
track. The company’s expansion into the Unites States, carefully timed after delays caused by the COVID-19
pandemic, demonstrates its commitment to thoughtful, sustainable growth rather than chasing rapid expansion at
the expense of quality.
For small biotechs, that performance often translates into a critical competitive advantage. By accelerating trial
start-up and execution, SanaClis helps emerging companies generate the data they need to secure funding, attract
partners, or move quickly into the next phase of development. For more established clients, the same operational
discipline keeps complex, global programs moving smoothly, avoiding the cascading delays that can cost millions
and disrupt strategic timelines.
Equally telling is the company’s steady growth. SanaClis has maintained roughly 25% year-over-year expansion,
not just in revenue but in organizational capability, reflecting both the trust of returning clients and the ability to scale
responsibly without compromising quality. This sustained momentum is supported by high client retention and a
reputation for being an “easy partner to work with,” a factor that often leads sponsors to deepen relationships across
multiple programs as their pipelines advance.
These results make clear that the SanaClis model delivers on its promise: providing right-sized, high-quality support
that adapts to each sponsor’s needs while consistently driving programs forward with speed, precision, and
reliability.
Conclusion
The journey from discovery to clinical success is rarely straightforward, particularly for smaller and emerging
sponsors operating with limited resources and high stakes. What these companies need is not just a vendor but a
true partner that understands their unique pressures, adapts to their pace, and scales with their growth. SanaClis
has built its approach around that need, combining the depth and infrastructure of a global CRO with the agility,
attentiveness, and responsiveness of a boutique organization.
By tailoring support models to each sponsor, integrating all critical services under one roof, and maintaining a team
structure that values focus and continuity, SanaClis delivers more than operational efficiency. It offers sponsors
confidence and the assurance that their studies will be executed with the speed, rigor, and care required to keep
their programs on track and their investors and stakeholders aligned.
For emerging biotechs, this means having a trusted partner that can accelerate early development without
overcomplicating processes. For more established organizations, it means a scalable solution that can handle
complex, multi-region programs without losing the personal, collaborative approach that makes a partnership truly
productive. In every case, the goal remains the same: to provide right-sized support for right-sized sponsors,
empowering innovation and helping promising therapies reach patients faster. With thousands of projects delivered,
hundreds of thousands of shipments executed, and a consistent record of on-time delivery, SanaClis offers
sponsors more than promises — it offers a proven model for driving clinical success.