← Preclinical Services
Preclinical Services
WE ACCOMPANY YOU
We are committed to being your trusted partner throughout the entire journey of your medical device product development. From the early stages of proof of concept to regulatory GLP studies for esteemed organizations such as the FDA, cFDA, or Notified Bodies, we provide comprehensive support tailored to your unique preclinical needs.
Our preclinical services encompass a wide range of critical elements, including study design, model selection, protocol writing, and medical device performance evaluation. With our expertise in pathology, both macroscopic and microscopic evaluations, we offer valuable insights into the effects of your technology on soft and hard tissues. Additionally, we assist in the preparation of regulatory dossiers, ensuring compliance with the necessary requirements.
With our integrated chain of services, we provide a convenient one-stop-shop experience for a higher level of efficiency. By streamlining your preclinical development process, we help reduce time to market and overall costs. Our team performs a diverse array of procedures, including open surgeries, interventional procedures, and device implantations, accompanied by advanced imaging and comprehensive pathology analyses. Through this multidimensional approach, we guide your innovative technology to reach new heights.
PROOF OF CONCEPT, R&D AND FEASIBILITY STUDIES
Unleashing the Potential of Early-Stage Innovations.
We understand that the early stages of medical innovation are crucial for success. For proof of concept and feasibility studies, we provide the expertise, attention to detail, and flexibility required to unlock the potential of nascent technologies.
In proof-of-concept studies, we work closely with emerging technologies, offering guidance and advising our clients on their development. Our experienced team troubleshoots product design challenges, facilitating improvement and innovation while not claiming any intellectual property. We excel in real-time problem-solving, enabling successful completion of procedures with early prototypes and collecting essential data and images to demonstrate the project’s promise to key stakeholders.
In R&D and feasibility studies, we prioritize consistency by maintaining a surgical and technical team that remains dedicated across cases. Our meticulous approach focuses on perfecting product design, delivery systems, and placement procedures, taking into account factors such as ease of use, navigability, risk of tissue trauma, and thrombogenicity. Our expertise spans multiple disease models, providing comprehensive insights into the feasibility and potential impact of your innovation.
At Veranex, we prioritize efficiency to reduce time to market and costs. Our consultative approach ensures the utmost confidentiality of your technology, results, and intellectual property. We adhere to strict procedures and guarantee a complete service marked by rigor, adaptability, and on-time performance. Our highly trained team is adept at managing unexpected events commonly encountered in early studies, ensuring seamless progress throughout the process.
With a global presence and a track record of working with leading companies in the United States, Europe, China, and Israel, we have earned a reputation for our unique capabilities and approach. Choose us as your trusted partner for proof of concept and feasibility studies, and benefit from our client-oriented, efficient, and passionate commitment to driving your innovation forward.
GLP-COMPLIANT STUDIES
Uncompromising Quality and Regulatory Excellence.
We are committed to conducting GLP-compliant studies of the highest caliber. With our stringent quality assurance system, we ensure pristine data that meet the rigorous standards set by regulatory authorities. As an accredited institution with the necessary authorizations from French regulatory institutions, we have undergone FDA and OECD inspection and validation, further affirming our commitment to excellence.
Our institutional Animal Care and Use Committee ensures that all studies conducted at our facility strictly adhere to the Guide for the Care and Use of Laboratory Animals and European Community recommendations. For advanced studies and those intended to support regulatory submissions, we follow Good Laboratory Practices (21 CFR part 58). This includes the utilization of written protocols, standard operating procedures, calibrated equipment, accredited large model facilities, skilled personnel, rigorous data tracking, robust biostatistics, and the preparation of formal study reports.
In our pursuit of our clients’ success, we understand that technical expertise in the operating room alone is not enough. Enduring and compelling results demand flawless data collection, which undergoes constant scrutiny, verification, validation, interpretation, and archiving within our robust quality assurance system. Adhering to Good Laboratory Practices, we ensure that our work aligns with the highest professional standards in preclinical research.
Our GLP-compliant studies have a proven track record of success in supporting regulatory submissions for both US FDA and worldwide regulatory bodies. Veterinary surgeons meticulously and consistently perform all procedures, contributing to an outstanding 95% success rate. This not only saves time and costs but also upholds the Three Rs principle of animal research, emphasizing the principles of Replacement, Reduction, and Refinement.
Together, we will navigate the path to success while maintaining the utmost commitment to animal welfare and scientific rigor.
PATHOLOGY EVALUATION
Unraveling Insights through Comprehensive Analysis.
Our in-house Pathology Department offers a comprehensive and state-of-the-art portfolio of services, ensuring the safety, performance, and efficacy assessment of new biomaterials or devices. With a commitment to GLP compliance, our expert team provides integrated sample processing, evaluation, interpretation, and reporting.
Pathology plays a crucial role in evaluating device safety and performance in preclinical research and is pivotal in regulatory guidance documents such as ISO 10993, ASTM International, OECD guidelines, and FDA recommendations. Through meticulous macroscopic and microscopic evaluations conducted in carefully selected large models, we gather critical information about the biological responses to medical devices or biomaterials.
Our team of veterinary pathologists collaborates closely with our veterinary surgeons, conducting protocol design, macroscopic assessments, and tissue sampling. Histopathological observations are interpreted comprehensively and integrated with clinical outcomes, imaging data, and macroscopic findings at the time of explantation.
With years of hands-on experience, our pathologists deliver reliable and skilled services tailored to meet our clients’ needs. In addition to routine histology services, such as paraffin embedding, sectioning, and standard staining, we also offer specialized techniques. These include frozen sectioning, MMA resin embedding of hard implants, EXAKT® cutting and grinding, special stains for qualitative assessment, and immunohistochemistry for specific cell or tissue component visualization.
Histopathology reports from Veranex are renowned for their clarity, didactic nature, and rich illustrations. They include narrative descriptions, qualitative and semi-quantitative assessments, individual data from large models, annotated microphotographs, and histomorphometry data. We can also provide professionally edited images suitable for publication and organize oral presentations and scientific discussions upon request.
INTERVENTIONAL AND SURGICAL TRAINING
Empowering Expertise for Optimal Clinical Application
In the realm of novel medical devices, surgical training is an essential requirement for investigators, clinicians, and sales representatives alike. At Veranex, we recognize the critical role of training in advancing patient care. Located in the heart of Paris, our dedicated research center provides state-of-the-art facilities that mirror hospital operating rooms (ORs) and catheterization laboratories (Cath labs), ensuring a seamless transition to human use.
We offer tailored training sessions in up to 6 operating suites simultaneously, designed to meet the specific needs of our clients. Our fully-equipped technical platforms replicate the hospital environment, offering a familiar setting for hands-on surgical procedures and wet labs. With lecture halls and classrooms accommodating up to 150 seats, we provide the space and resources necessary for effective teaching sessions.
In addition to in-person training, we offer real-time remote training capabilities, allowing participants to engage from adjacent conference rooms or remote locations. Our video communications capabilities ensure seamless observation and interaction during the training sessions.
Veranex goes beyond technical support, offering comprehensive event-planning assistance. We assist in arranging hotel accommodations, transportation, and catering services, ensuring a hassle-free and productive training experience.
Our team is dedicated to helping you plan and execute comprehensive training sessions for your investigators, customers, salespeople, and other guests. We aim to empower your key stakeholders with the knowledge and skills required for successful clinical application.
Examples of our training experience span various fields, including cardiology, vascular interventions, ophthalmology, robotics, and more. Whether it’s implantable heart valves, coronary artery stents, or laparoscopy instruments, our expertise extends to a wide range of technologies. We have conducted training with cutting-edge systems such as Philips 3D rotational angiography, Philips EPIQ Evolution 3.0 echocardiography machines, and robotic surgical systems like Robocath’s R-One.
We understand the importance of providing a supportive and conducive environment for learning. Our fully refurbished research center offers an attractive and comfortable space, fostering a productive training atmosphere. We are committed to facilitating successful training sessions for your team, ensuring they are equipped with the knowledge and experience to utilize sophisticated medical technologies effectively.
Together, let’s elevate your team’s skills and enhance patient care through comprehensive training sessions that are tailored to your specific needs.