ESENCHY THERAPEUTICS
TECHNOLOGICAL AND CLINICAL CONSULTING
Technological Consulting
Esenchy manages two brands in the Medical Technological Field : Etherai Visions and TrialBlock
ETHERAI VISIONS
In Etherai cutting-edge AI meets the future of clinical trials.
Discover how our innovative approach addresses the critical needs in drug development, sparking interest from diverse pharmaceutical leaders. Our company's technology minimizes patient exposure in clinical trials, positioning us as the go-to solution for progressive pharmaceutical companies, constantly Innovating as our functional, intelligent control arm for regulatory authorization.
Research:
- Dive into the transformative world of cutting-edge technology that turns unmet medical needs into compelling AI-driven solutions.
- Discover how our focused research on rare diseases and oncology captivates the attention of pharmaceutical leaders.
- Uncover the potential of AI in revolutionising the drug development process, making it an attractive proposition for industry players.
- Stay tuned for updates on our upcoming product—an intelligent control arm ready for regulatory authorization.
Botients:
- Understand how our innovative approach transforms the necessity for clinical trial subjects into a compelling solution—Botients, the future of research.
- Explore the undeniable advantages of utilising Botients in trials, turning the need for patient safety into an irresistible call for innovation.
- Learn about the ethical considerations and safeguards that make Botients a must-have solution for responsible and progressive research.
- Preview our upcoming product line, featuring an intelligent control arm designed to streamline regulatory authorization processes.
Clinical Trials:
- Learn how the pressing need for more effective clinical trials is met with the transformative impact of AI, making us the industry's preferred choice.
- Explore our ongoing and completed trials, showcasing how our technology is addressing industry challenges and creating new possibilities.
- Understand why choosing us means embracing the future of drug development and influencing positive change in the pharmaceutical landscape.
- Anticipate the introduction of our groundbreaking product—a functional, intelligent control arm for seamless regulatory approval in clinical trials.
TRIAL BLOCK
In Trial Block we revolutionize clinical trials through blockchain technology.
We explore with our innovative approach in data collection within clinical trials and observational studies, which enhance transparency
and security.
Let us teach you how we empower patients with our unique formula, allowing them to take control and make decisions about their data, becoming the rightful owners.
Dive into our mission to increase the value of blockchain by incorporating truthful, audited data from CROs, Sponsors, and Regulatory Agencies.
Blockchain Data Collection:
- Discover the transformative power of blockchain in securely collecting patient data for clinical trials and observational studies.
- Explore the benefits of obtaining patient consent for data sharing through a digital data collection notebook.
- Learn about our patient-centric formula, granting patients control and decision-making authority over their data on the blockchain.
- Explore the smart contract system that enables patients to share data selectively, on their terms.
Value-Driven Blockchain:
- Understand the correlation between the value of blockchain and the inclusion of truthful, audited data from CROs, Sponsors, and Regulatory Agencies.
- Explore how our platform adds significant value by creating a trustworthy ecosystem for all stakeholders in the clinical research process.
- Learn about the benefits of contributing verified data to the blockchain and the impact on the overall value of the system.
Tokenization:
- Dive into the future with our tokenization approach to clinical trial data.
- Explore the benefits of tokenizing data, creating a valuable and exchangeable asset in the clinical research landscape.
- Understand the potential for stakeholders to participate in and benefit from the tokenized ecosystem.
COMPANY
Our team members come from companies that have been pioneers in the implementation of Quality Standards in the Technological , biotech and pharmaceutical industry. We are specialized in the development of Advanced Therapies and Innovative Medicines for the manufacturing of Gene and Cell Therapy medicines for clinical trials.
We are a client-centered company. In addition to providing our own services, we work with our clients and offer them, upon request, one-off collaboration with other companies with expertise in each of the project’s strategic areas: Engineering (for the design and set-up of facilities).
Clinical Services
Technical, regulatory and strategic consulting.
We provide regulatory, technical and quality assurance support as well as project feasibility studies, training, management of technology transfers, auditing services and the preparation of the necessary documentation.
Training
Ample training program and seminars in the field of Advanced Therapies, covering different aspects of regulations and development. We also provide training in the peculiarities of Manufacturing and Quality System processes.
Implementation of Good Manufacturing Practices (GMP)
We advise, cooperate and collaborate with clients who need our wholistic consulting services for the implementation, training and GMP certification of manufacturing facilities for Advanced Therapies and Innovative Medicines.
Elaboration of quality documentation
We prepare specific documentation and elaborate standardized working procedures; validation protocols adapted to your organization; processes and a Quality System that will comply with the requirements of Quality Standards.
Project feasibility studies
We collaborate with our clients in the design of their optimal regulatory path. We also make a financial assessment to determine the investment needed for the development of medicines for Advanced and Innovative Therapies.
Preparation and review of Clinical Trial application forms
We prepare and/or review the Investigational Medicinal Product Dossier (IMPD), based on the documents shared by the client as well as the Research Protocol.
Preparation of the application document for the Use Authorization
We prepare the documentation to apply for the Use Authorization for Advanced Therapy Medicinal Products (ATMPs) (quality, clinical and non-clinical documentation) of non-industrial manufacturing, in the context of hospital institutions.
Technology transfer
Our manufacturing process comes from a GMP point of view. We offer clients determine the most appropriate manufacturing process, scale-up, validation and quality control. We also elaborate the necessary documentation for each Advanced Therapy Medicinal Product (ATMP) for those clients who need to adapt their R&D products and processes to standardized GMP manufacturing or who need to transfer their manufacturing processes to another manufacturer (CMO).
Cell Therapy Products & Services
The complexities of cell therapy programs present not only scientific but technical challenges as well. They are highly customized and vary greatly based on product attributes. Due to tremendous promise to cure many types of diseases, there is significant pressure to accelerate these programs through regulatory approval faster than ever. It is therefore crucial to find a partner who offers access to a robust scientific and regulatory network and integrates the various elements of your program to achieve your milestones.
Research-use Human Cells
Fresh and cryopreserved leukopaks, mobilized leukopaks, bone marrow products, cord blood products, and isolated cells (MNCs, T cells, NK cells, and other cell populations) to support and expand your research efforts.
GMP-compliant Human Cells
Cell sourcing for superior leukopak and bone marrow aspirate cellular starting material that adheres to strict cGMP requirements for the advancement of autologous and allogeneic cell therapies.
Diseased State Biospecimens
Our cell sourcing capabilities include Covid-19 related products, isolated immune cells, tissues, and fluids collected from patients undergoing treatment for various disease types.
Specialized Products
Customizable product requests, antigens, bio/cryopreservation media, and in vivo solutions.
Customized Products and Services
Beyond cell sourcing material, we offer specialized services such as targeted donor recruitment through HemaCare Donor Center (a Charles River company) and contract research to facilitate the success of your cell therapy.
Animal Primary Cells
We offer a large selection of cryopreserved murine immune system mast cells, bone marrow cells, dendritic cells, macrophages, spleen cells, and chondrocytes to complement our human immune cell products.
OUR WORKS
1. Regulatory,
We understand the scientific and technical challenges , it’s for that we work ensuring compliance, flexibility on the production capability and on-time delivery.
A vital part of the clinical trial or marketing application, or post-approval strategy is CMC (Chemistry, Manufacturing and Control). We reach our milestone with scientific and regulatory expertise in all areas of CMC development. In order to ensure our program progresses as scheduled. During Drug Substance and Drug Product development, we follow specialized guidance and support. At ESENCHY, we understand how to anticipate and overcome potential difficulties in the development of new chemical entities and biologics, including cell and gene therapy.
2. Preclinical development,
Due to the increasing complexity of drug development and regulatory environment, the nonclinical and clinical plan, critical component, throughout the healthcare product development cycle require more and more customization and global vision. Nonclinical and clinical data are presented and interpreted in various regulatory interactions during the life cycle of a product.
At ESENCHY, our regulatory and nonclinical experts help design an optimal nonclinical development plan and prepare critical meetings with regulatory agencies adopting a benefit-risk approach to enable our products to move to the next phase.
3. Clinical Development,
- Study Design: Design and review patient-centric protocol with endpoints. Align the study with overall development goals taking into account all stakeholders.
- Study Preparation: Optimize the timeline to first-patient-in. Advice for patient recruitment and network building. Legal representation in the EU/EEA, UK and Switzerland.
- Study Submission: Prepare and submit clinical trial application to secure study approval.
- Study Conduct & Data Management & Analysis: Optimize interaction between all stakeholders and ensure data collection and quality supporting your endpoints.
- Our deep understanding and discerning power regarding the regulatory requirements and their implementation in different bodies and regions brings unique insights to our project.
- We have a global reach and the capability to manage the study long-term.
- Our therapeutic expertise, product knowledge and know-how in orphan diseases, oncology and immunology empower us for today’s complex studies.
- Clinical Safety: Build a scalable safety system, oversee and manage the clinical risk assessment.
- Regulatory Maintenance: Maintain regulatory dossier to ensure compliance.