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CALYM and EMBLEEMA sign a strategic partnership to deploy next-generation clinical research solutions for life sciences.

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L’objectif, avec Embleema, éditeur de logiciels innovants pour les plateformes de données cliniques réglementaires axées sur le patient pour la médecine de précision, est d’améliorer :

  • la performance de la R&D grâce à des technologies innovantes permettant des échanges de données pleinement consenties,
  • le recrutement et l’engagement des patients, ainsi que la production de preuves de qualité réglementaire.

La recherche clinique en médecine de précision souffre actuellement d’un recrutement et d’un recrutement et maintien dans l’étude ardus des patients, de cadres de consentement peu clairs pour l’utilisation secondaire des données et d’un manque de normes réglementaires pour les thérapies multi-omiques.

 

La combinaison des capacités de classe mondiale de CALYM et d’Embleema apporte des solutions de R&D uniques aux promoteurs pour :

  • un meilleur recrutement des patients,
  • le consentement et l’engagement des patients,
  • l’échange de données pleinement consenties et vérifiables, et la production de preuves de qualité réglementaire.
“Patients are at the center of all medical research projects. Transparency, security, and data accessibility are major concerns. It is a privilege to partner with Embleema to build the next generation of a patient-centered trust network with all stakeholders involved in our research programs.”
Emmanuel Gomez, 
CEO of CALYM
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Embleema offers enhanced patient consent management through blockchain for clinical trials and long-term follow-up studies, along with the generation of regulatory-quality evidence through its big data and bioinformatics platform HIVE, currently utilized by the FDA (Food and Drug Administration) and CDISC (Clinical Data Interchange Standards Consortium) to define evidence generation standards for cell and gene therapy.

The CALYM Carnot Institute’s network covers the entire R&D chain in the fight against lymphoid tumors to generate cutting-edge research programs. Scientific and medical expertise is supported by an academic investment center to develop the next breakthrough research for the ultimate benefit of patients.

By instilling trust in all aspects of clinical data for all stakeholders in the drug R&D ecosystem, including patients, investigators, researchers, sponsors, and regulators, the partnership between CALYM and Embleema marks a significant milestone in precision medicine R&D. It brings fundamental technological solutions for improved patient engagement and fully consented, regulatory-quality data exchanges, thereby accelerating the availability of new treatments for lymphoma.

“We are delighted to partner with CALYM and its world-class clinical research network in the field of lymphoma. By combining our capabilities, we will be able to accelerate R&D and bring new remedies to lymphoma patients more quickly.”
Robert Chu, 
CEO of Embleema
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ABOUT EMBLEEMA OUR NEW PARTNER

Embleema is the regulatory-grade health data platform that accelerates the discovery of new drugs and speeds up the commercialization of new treatments.

Embleema’s software platform enables patients to benefit more quickly from precision medicine by collecting and generating regulatory-quality evidence. Embleema’s platform inherently unifies clinical, molecular, and real-world data and is the only one used by the FDA for its regulatory evaluation of health products involving genomic datasets.

The protocols and algorithms within Embleema’s platform also form the basis for future CDISC standards for cell and gene therapies. In addition to the FDA, Embleema serves large pharmaceutical companies, biotechnology firms, patient advocacy groups, universities, and clinical research networks.

The CALYM Carnot Institute is delighted to partner with Embleema to establish the next generation of patient-centered drug management systems.

Read the press release