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Non clinical

Discovering and developing new candidates and formula is key to sustain R&D and accelerate product development and commercialization. Diversity and amount of data collected in R&D are increasing each year.

This is why Data Analysis and Data Sciences are taking a central place in exploiting this mine of information and help to make decision.

With our expertize regarding discovery and product development and evaluation we help our client either on pre-clinical studies, omics and biomarkers analysis or even CMC and Insights.

Data processing and explorationfor your in vitro & in vivo pre-clinical research projects

 

Pre-clinical Studies

OMICS & biomarkers

Data Analysis and Pipeline development for Omics and Biomarkers from R&D to Clinical Studies​

Insights

Data Analysis and Pipeline development for Omics and Biomarkers from R&D to Clinical Studies​

Data Sciences support for product development, quality, CMC and manufacturing​

 

Industrial statistics – CMC

Clinical

We provide comprehensive support to our clients throughout Phase 2 & Phase 3, covering everything from study synopsis design to the final study report and publication. By bringing extensive experience, in therapeutic areas such as cardiology, COVID-19, diabetology, gastroenterology, immunology, infectiology, neurology, oncology, rare diseases, rhumatology and others.. Alsinova offers a full spectrum of services, including medical support, pharmacovigilance, regulatory affairs, data sciences, clinical operations support. ​

While clinical trials are fundamentally people-centered projects, developed and conducted by people for the well-being of people, we recognize that the true power of digital solutions, AI, and automation in clinical trials is realized when these tools support and empower the people who design, manage, and participate in them. ​

By combining the human element with cutting-edge technology, we drive efficiency, innovation, and a more compassionate approach throughout the clinical development process.

EAP

Unlock rapid, secure access to innovative treatments with our expertise in managing Early Access Programs (AP1 and AP2)

Early Access Programs  play a critical role in giving patients the opportunity to access experimental treatments before they are officially approved. In urgent or life-threatening situations, where conventional therapies have failed, these programs offer a vital lifeline. As specialists in Early Access (AP2) and Compassionate Use (AP1), we provide end-to-end support, from program design to execution, ensuring full compliance, patient safety, and treatment efficacy every step of the way.

Tailored Solutions for Early Access Programs

We work with you to create a custom-tailored Early Access Program that aligns with your product’s specific needs and addresses the unique challenges faced by patients. This includes:

Navigating the Complex Regulatory Landscape

Managing an Early Access Program can be complex. We simplify communication and collaboration with regulatory agencies like the FDA, EMA, and other relevant authorities, ensuring all regulatory and ethical requirements are met.

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Comprehensive Safety and Efficacy Monitoring

We implement robust processes for monitoring adverse events, analyzing treatment safety and efficacy, and maintaining open communication with patients to ensure their well-being throughout the program.

Advanced Data Collection and Analysis

Using cutting-edge tools for data collection and analysis, we manage patient and healthcare professional feedback, providing you with detailed reports that support informed decision-making and continuous program optimization.

Why Choose Us for Your Early Access Program?

  • Regulatory Expertise: We bring extensive knowledge of regulatory processes, ensuring that your Early Access Program adheres to all relevant guidelines and regulations.
  • Patient-Centric Approach: Our focus is on patient safety and quality of care. We prioritize real-time monitoring and proactive risk management to protect patients at every stage.
  • Tailored Strategies: We understand that each program is unique. Our solutions are customized to meet the specific needs of your product and the patients it aims to help.
  • End-to-End Support: From initial program design to  follow-up, we handle every detail of your Early Access Program, allowing you to focus on what matters most: delivering life-changing treatments to patients in need.

With our experience and expertise, we ensure that your Early Access and Compassionate Use  programs run smoothly, efficiently, and in full compliance with global standards. Whether you’re launching a new treatment or offering a life-saving solution to patients in urgent need, our team is here to help.

Ensuring Access. Prioritizing Care.

RWE

Running a Real-World Study: Complex Challenges, Concrete Solutions with Alsinova

Clinical research is evolving. It is no longer confined within investigator sites—it now reaches patients where they live, thanks to hybrid and digitalized approaches. This transformation opens up new scientific opportunities, but it also brings significant challenges.

At Alsinova, we turn those challenges into performance drivers for your studies.

Healthcare Data Access: Complex by Nature

Long-Term Patient Engagement

Addressing Methodological Complexity

Human-AI Synergy

True empowerment

Accelerating Timelines with Agility

Healthcare Data Access: Complex by Nature

Finding and leveraging the right data for your study can quickly become overwhelming—massive volumes, diverse formats, and multiple sources (connected devices, national databases (SNDS), biobanks, etc.).

We design solutions that are natively interoperable and scalable, capable of adapting to data volume and variety. Our integrated analytics tools turn raw data into real-time, actionable insights at every stage of your project.

Long-Term Patient Engagement

Real-world studies require a new level of patient involvement. Sustained engagement is now a critical success factor.
Alsinova offers a truly patient-centric approach. From listening to patients’ needs to co-creating with advocacy groups, we design a smooth, inclusive, efficient, and accessible experience, from the first contact to the final form.

Accelerating Timelines with Agility

Time pressures around project management and publication deadlines are intensifying. Every day counts in bringing a treatment to market.
With agile digital tools, streamlined processes, and real-time dashboards, your teams can focus on high-value tasks. Your organization becomes more responsive—without compromising scientific rigor.

Addressing Methodological Complexity

Mixed-methods research, AI-powered analytics, advanced data visualization, and integrated qualitative/quantitative analysis—today’s studies demand specialized, often multidisciplinary expertise.
We bring together the best experts for each project, through our agile ecosystem of partners. You gain access to scientific and operational excellence tailored to your unique challenges.

Make Your Clinical Study a True EXPERIENCE

For PATIENTS

A human, engaging experience—designed to fit into their everyday lives.

For SPONSORS

An agile collaboration—for studies that are faster, smarter, and stand out.

For SITES

A trusted relationship—supported by tools that simplify day-to-day operations.

At Alsinova, we combine clinical expertise, technological mastery, and active stakeholder listening. Because we believe that a well-run study begins with a well-designed experience.

Why Choose Alsinova?

We don’t just support your studies—we elevate them. Here’s why our sponsors trust us:

  1. Certified Access to the SNDS
    We have been authorized to work with the French National Health Data System (SNDS) since 2017, enabling us to integrate rich, real-world data into your research securely and efficiently.
  2. Our Own Technology
    We own and operate a fully proprietary digital platform, built and maintained by our own engineering teams. This means greater control, continuous innovation, and fast adaptability to your study’s specific needs.
  3. Truly End-to-End Support
    From study design to data collection, analysis, and submission—we provide end-to-end project support. You get a single point of contact and seamless coordination across every phase.
  4. International Reach
    We work across multiple countries and regulatory environments, with the ability to manage real-world studies across hundreds of sites and thousands of patients in many countries.
  5. Human + Tech Synergy
    We believe in the perfect balance between human expertise and digital intelligence. Our teams combine clinical insight, tech mastery, and a deep understanding of stakeholders—from patients to sponsors.