Three Forces, One Vision:
Shaping the Future
For UAE, Qatar, Saudi Arabia, Oman, Bahrain and Kuwait
Three Forces, One Vision:
ABOUT US
Our Consortium CSD-HIVE and Neo-Science represents a strategic alliance between two leading U.S.-based technology pioneers and UAE-based partner, specializing in various software platforms: including regulatory genomics and digital healthcare infrastructures, clinical data monitoring system, patient registry, Real World Evidence information platform. With a focus on healthcare technology, personalized medicine, and precision therapeutics, our consortium boasts a track record of excellence in developing tailored data management platforms for healthcare and clinical research. Our clientele includes esteemed organizations such as the FDA, NIH, NCI, CDC, as well as publicly traded biotechnology, pharmaceutical companies and academic institutions.
- HIVE - CSD Capabilities
- United States FDA Partnership
- Successes and Impact
- European Regulatory Landscape
- Neo - Science Local Partner
HIVE – CSD Capabilities
The HIVE-CSD data systems include platforms for genomic and multi-omics, centralized clinical data monitoring, data quality and integrity, data integration and reconciliation, analysis and reporting. Our technologies have been pivotal in empowering significant healthcare and research entities, establishing a critical role in regulatory review process, particularly U.S. Food and Drug Administration (FDA). This longstanding partnership underscores our commitment to advancing healthcare technology, significantly contributing to medical research and patient care enhancements.
United States FDA Partnership
Central to our collaborative efforts of HIVE-CSD, is our role in the development and deployment of the HIVE (High Performance Integrated Virtual Environment) protocol, a project in concert with the United States Food and Drug Administration. This collaboration underscores our commitment to propelling healthcare technology forward, marking a significant stride in medical research and patient care improvement (Wilson & Simonyan, 2014) . Since 2011, the U.S. Food and Drug Administration (FDA) has utilized the HIVE platform as the exclusive platform for research and regulatory reviews.
The US FDA recognizes HIVE as the only platform Authorized to Operate (ATO) in a regulatory environment big data platform fit for genomic datasets.
Successes and Impact
The HIVE-CSD technology has been used by numerous government and private industry programs for clinical research, quality control, and data standardizations. This technology has been a part of many successful regulatory submissions and FDA approvals, including precision medicine cell and gene therapy products, NGS based companion diagnostic systems, pathogen diagnostic systems, medical device technologies, vaccine development and treatments for oncological and rare diseases.
European Regulatory Landscape
In addition to our successful operation under U.S. regulatory landscape, we have successfully navigated the European regulatory landscape, adhering to the European Medical Devices Regulation (EU MDR), the In Vitro Diagnostic Regulation (IVDR), and ensuring compliance with GDPR and HIPAA.
Neo – Science Local Partner
Neo-Science, our esteemed local partner based in Abu Dhabi, brings invaluable expertise in Life Sciences, Molecular Diagnostics, Omics, Bioinformatics, and AI reporting tools for both research and clinical sectors. With their local presence and extensive experience, Neo-Science will play a crucial role in providing project management support and technical expertise for the successful implementation of the related projects in GCC region (UAE, Qatar, Saudi Arabia, Oman, Bahrain and Kuwait).
0+
Years in Business
0%
Team Members with MS, MA, MD, Ph.Ds
0%
Client Return Rate
0+
Successfully Delivered Projects
SERVICES & PRODUCTS
We understand every project has unique demands. That’s why our products are fully customizable to meet each client’s specific needs. Whether it’s diagnostics, genomics, OMICS, or AI, we work with you to deliver tailored solutions that align with your project’s goals, ensuring precision and value.
Let’s talk
Have a project in mind?
info
Let’s collaborate to bring your vision<br> to life with our expert solutions
mail_outline
phone_in_talk
