In an age where healthcare is evolving faster than ever, the organizations that stand out are not just innovative — they’re built on vision, precision, and an unshakeable focus on the human being at the center of it all. CEBIS International is one such organization. And behind it stand two complementary forces: Mihai Manolache, the visionary CEO shaping the future of precision medicine, and Andreea Manolache, the meticulous Chief Operations Officer who ensures that future is delivered flawlessly, every single day.
Together, they’ve turned an idea launched in 2007 into a global life sciences group operating across 29 countries, with 1,000+ professionals, three operational hubs, and a track record of managing over 100,000 patients monthly across a wide range of therapeutic areas.
“You don’t build something this big by thinking short-term,” says Mihai.
“And you don’t scale it without discipline,” adds Andreea.
“We’ve always believed that innovation only matters if it reaches the patient.”
Let’s see how CEBIS International delivers patient-centered healthcare innovation across continents, from genomics to digital trials!
From a Shared Vision to Global Impact
What began as a joint dream—two young professionals committed to bringing clinical science closer to the people it was meant to serve—has become a blueprint for integrated healthcare innovation. Today, CEBIS International provides:
- Clinical trials from Phase I to IV (including FIH, BA/BE)
- Advanced genomic and genetic testing
- Decentralized and hybrid clinical trials
- Patient support and adherence programs
- Digital health infrastructure and medical logistics
Their shared leadership style is based on trust, transparency, and accountability. Mihai leads strategy, innovation, partnerships, and global development. Andreea leads operations, logistics, quality assurance, training, and execution. Together, they’ve crafted a company that’s as fast as a startup, as reliable as a multinational, and as grounded as a family business.
Three Continents, One Coordinated System
At the core of CEBIS’s infrastructure is a tri-continental hub system:
- Lugano, Switzerland: European HQ focused on quality, ethics, and clinical governance
- Houston, Texas: Command center for North American studies and partnerships
- Hyderabad, India: Execution hub powering data science, biostatistics, and tech
And yet, the true engine remains in Bucharest, Romania, where Andreea leads the Global Operational Hub that manages project execution, logistics, finance, training, compliance, and site coordination.
“Bucharest is more than our origin—it’s our backbone,” says Andreea. “We’ve proven that world-class infrastructure can be led from Eastern Europe.”
Genomic Testing: The Next Chapter in Precision Medicine
This year, the group launched a new frontier: genomic and genetic testing services under the CEBIS umbrella.
The service, which went live in July, empowers physicians to tailor treatment based on molecular signatures. It’s a bold leap into personalized medicine, and it’s fully integrated into the CEBIS patient ecosystem—supporting everything from oncology and cardiology to neurology and autoimmune diseases.
“This isn’t an accessory—it’s a strategic core,” says Mihai. “We want to empower real-time, data-driven decisions that optimize therapy and reduce uncertainty.”
Andreea’s team managed the roll-out with absolute precision: logistics, compliance mapping, integration with digital platforms, and patient reporting. “We didn’t just launch a platform—we launched a fully operational, Europe-wide advanced diagnostic service in under 30 days,” she says.
What Sets CEBIS Apart
At CEBIS, innovation and execution are two sides of the same coin. That duality is what separates them in a crowded life sciences space. Among their unique differentiators:
- Full patient lifecycle services: From trial enrollment to real-world evidence
- Global standards compliance: ISO 9001, 13485, 27001, 45001
- Smart digital platforms: Including IRT, CTMS, EDC, and AI-driven trial design
- Real-time patient support infrastructure, fully multilingual and multinational
- Integrated genomic testing aligned with PSPs and decentralized trials
“We don’t believe in siloed services,” says Mihai. “We design medical ecosystems where patients, physicians, healthcare companies, and data all work together—seamlessly.”
Operational Excellence: The Andreea Way
If Mihai is the architect, Andreea is the chief engineer. Her ability to manage complexity across borders, languages, and systems is the glue that keeps CEBIS running with military-grade consistency.
Her operational framework includes:
- Real-time dashboards and escalation ladders
- Cross-trained regional teams
- Audit-ready documentation at all times
- Training programs for GCP, pharmacovigilance, and decentralized monitoring
“Innovation only matters if it’s delivered with accuracy. My role is to protect that executional trust,” says Andreea.
A Culture of Ethics, Innovation, and Impact
CEBIS has embedded a deep culture of accountability and human-centered performance. Their leadership model includes:
- Weekly executive briefings across time zones
- Active mentorship for emerging leaders
- KPI dashboards at every level of the organization
- Biannual audits of adherence and patient engagement protocols
- Constant reinvestment in staff training, certification, and well-being
“We hire based on mindset first. Skills follow,” says Andreea. “We build people who can think, adapt, and lead.”
Extending the Vision: CEBIS Capabilities and Global Reach
CEBIS International has grown not only in scope but in technological depth. With over 360 clinical trials completed, a presence in more than 30 locations worldwide, and a database of over 150,000 screened patients, CEBIS delivers global clinical research services through a highly specialized infrastructure.
The company’s digital transformation is anchored in its proprietary platform, TRIAL-HUB®, which supports everything from AI-powered protocol design and real-time feasibility analysis to automated SAP generation and CTA workflow optimization. All systems are 21 CFR Part 11 and EU CTR compliant, ensuring audit-readiness and global compatibility.
Preclinical and early-phase operations
In preclinical and early-phase operations, CEBIS boasts a 60-bed state-of-the-art facility equipped with Class 100,000 cleanrooms, onsite diagnostic tools, an in-house pharmacy, and a CLIA-certified safety lab. This environment supports Phase I and proof-of-concept studies across diverse populations including renal/hepatic impairment, metabolic syndromes, and CNS disorders.
On the late-phase front, CEBIS specializes in decentralized and hybrid trial models, remote monitoring, wearable integration, and site-less data capture. These capabilities dramatically increase recruitment speed, retention rates, and data richness, while lowering cost and burden on participants.
Its bioanalytical lab spans 700 sq meters and is equipped with Triple Quad LC-MS/MS systems and over 250 validated methods. Data management services include CDISC-compliant database programming, SDTM/ADaM datasets, real-time analytics, and eTMF integration.
Therapeutic expertise covers a wide range: oncology, hematology, gastroenterology, immunology, rheumatology, gynecology, nephrology, infectious diseases, gene and cell therapy, neurology, rare diseases, and pediatrics. This depth ensures robust scientific and operational support across all study phases.
Patient support and patient adherence programs
Patient support remains central. CEBIS employs a team of adherence-focused professionals—nurses, doctors, psychologists—working via PSP eMed and digital platforms to guide patients through every step of treatment. These programs not only improve outcomes but generate rich real-world data for sponsors and physicians alike.
Quality and safety are embedded in CEBIS’s operations through an independently structured Quality Management System (QMS) that emphasizes data integrity, process standardization, regulatory compliance, and continuous improvement.
The combined leadership of Mihai and Andreea Manolache has elevated CEBIS to a gold standard in patient-centric research delivery, offering speed, scale, and scientific rigor without ever compromising on care. With operations bridging continents, disciplines, and technologies, CEBIS continues to shape the future of global health innovation.
AI and Technology: Catalysts for Intelligent Clinical Trials
At the heart of this transformation is TRIAL-HUB®, a proprietary digital platform developed by CEBIS. It includes modules for AI-powered protocol development, statistical analysis plan (SAP) design, and smart CTA preparation. These features allow for rapid trial startup and a streamlined regulatory workflow—reducing operational delays while enhancing compliance with global standards such as 21 CFR Part 11 and EU CTR regulations.
The platform includes a smart validation engine that flags inconsistencies and feasibility gaps in real time, ensuring protocols are both medically relevant and operationally executable. Version control, audit trails, and real-time collaboration interfaces across clinical, regulatory, biostatistics, and medical affairs teams provide unmatched transparency and coordination.
The integration of digital twins—virtual models of trial patients—is the next frontier. By simulating how a treatment would impact an individual based on their real-world data and genetic profile, CEBIS aims to refine treatment protocols in a predictive environment before real-world administration.
This fusion of clinical science with advanced technology enables CEBIS not only to accelerate research timelines but to do so with greater precision, safety, and insight. It is a future-ready approach that ensures every patient receives the most informed, optimized, and compassionate care possible.
Real Stories, Real Impact
CEBIS recently ran a multi-country oncology support program that combined clinical trial data with genomic insights and adherence protocols. The results were extraordinary:
- 90% patient adherence
- 48% fewer unplanned hospitalizations
- 3x more timely dose adjustments
- Improved outcomes and lower cost of care
This wasn’t a study. It was a clinical transformation, and it’s the model CEBIS now exports globally.
What’s Next: Vision 2026
With 2026 on the horizon, Mihai and Andreea are focused on:
- Scaling genomic testing into 10+ new markets
- Expanding AI-powered predictive models for treatment stratification
- Launching a modular licensing model for global PSPs
- Deepening decentralized trial infrastructure
- Building digital twins for simulation of long-term clinical outcomes
“We don’t want to grow just to get bigger,” Mihai says. “We want to grow smarter, deeper, and in ways that create generational change in how healthcare is delivered.”
Final Thoughts
The story of Mihai and Andreea Manolache is not one of overnight success or flashy headlines. It’s the story of discipline and devotion, of thinking long-term and acting decisively. Together, they’ve built a company that isn’t just part of the healthcare system—it’s actively shaping its evolution.
Their message is simple but powerful:
Innovation only matters when it reaches the patient – safely, precisely, and with empathy.
And that’s exactly what CEBIS International was built to do.
Mihai Manolache – PhD, Founder & CEO
Andreea Manolache – Co-Founder & Chief Operations Officer
📍 Headquarters: Lugano | Houston | Hyderabad | Bucharest
🌐 www.cebis-int.com | www.cebisusa.com
