This strategic partnership brings next-generation, patient centered clinical research solutions to the healthcare industry. The purpose is to improve R&D performance through innovative technologies powering fully-consented data exchanges, enhanced patient recruitment and engagement, as well as regulatory-grade evidence generation.
PARIS & METUCHEN, N.J., December 07, 2022--(BUSINESS WIRE)--CALYM Carnot Institute, the academic consortium dedicated to public-private partnership research in lymphoma, and Embleema, the innovative software provider for patient-driven, regulatory clinical data platforms for precision medicine, today announced a strategic partnership to develop next-generation clinical research solutions aimed at accelerating clinical innovation.
Clinical research in precision medicine currently suffers from arduous patient recruitment and retention, unclear consent frameworks for secondary use of data, and lack of regulatory standards for multi-omics based therapies. CALYM and Embleema’s combination of world-class capabilities brings unique R&D solutions to sponsors for enhanced patient recruitment, consent and engagement, fully-consented and auditable data interchange and generation of regulatory-grade evidence.
"Patients are at the center of all medical research projects. Data transparency, security and accessibility are key concerns. It is a privilege to partner with Embleema to build the next generation trusted patient centered network with all stakeholders involved in our research programs" says Emmanuel Gomez, General Manager of CALYM Non-Profit Organization.
Robert Chu, Chief Executive Officer of Embleema added: "We are very excited to partner with CALYM and its world-class clinical research network in Lymphoma. By combining our capabilities, we will be able to accelerate R&D and bring new cures faster to patients suffering from Lymphoma."
Embleema provides blockchain-enforced patient consent management for clinical and long-term follow-up studies and regulatory-grade evidence generation through its HIVE big data and bioinformatics platform currently in use by the U.S. Food and Drug Administration and by CDISC for defining evidence generation standards in cell and gene therapy.
CALYM Carnot Institute network covers the full R&D chain in the fight against lymphoid tumors to generate state of the art research programs. Scientific and medical expertise are supported by an academic investment center to develop next state of the art research, for the final benefit of patients.
By bringing trust in every aspect to the clinical data for every stakeholder of the drug R&D ecosystem, whether patient, investigator, researcher, sponsor, or regulator, CALYM and Embleema’s partnership mark an inflection point in precision medicine R&D by bringing foundational technology solutions for enhanced patient engagement and fully-consented, regulatory-grade data interchanges ultimately accelerating the availability of new cures in Lymphoma.
Embleema's software platform brings precision medicine sooner to patients by collecting and generating regulatory-grade evidence. Embleema’s platform natively unifies clinical, molecular and real-world data and is the sole one used by the FDA for its regulatory evaluation of health products involving genomic datasets. The protocols and algorithms contained in Embleema’s platform are also the basis for future CDISC standards for cell and gene therapies. In addition to the FDA, Embleema serves leading pharmaceutical companies, biotechs, patient advocacy groups, academia and clinical research networks.
For more information, please visit www.embleema.com.
About CALYM, Carnot Institute
CALYM is the academic consortium of experts dedicated to partnership-based research. The purpose of the Carnot Institute CALYM, a consortium for the acceleration of innovation and its transfer to the field of lymphoma research, is to promote the development of diagnostic and care solutions for lymphomas, in partnership with the public and private socio-economic sector. It consists of 20 complementary research organizations: 18 public research laboratories, LYSA cooperative group, and LYSARC, its academic clinical research organization.
For more information, please visit lymphoma-research-experts.org/calym/.
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Emmanuel Gomez (CALYM), +33 613 254 334
Robert Chu (Embleema), +1 914 572 8108