Monday, October 15, 2018
Certara, a leader in model-informed drug development, regulatory science, market access and real, world evidence solutions, today announced that it has formed a strategic collaboration with Hedera Hashgraph. Synchrogenix, Certara’s regulatory sciences division, has been building distributed applications in the life sciences and healthcare markets that will expand its reach in the areas of transparency and disclosure, regulatory reporting and data sharing, and collaboration/communications from drug development through market access.
“We are experiencing a period of unprecedented growth in science and technology. The promise of distributed ledger technologies, such as those used by other highly regulated industries, including financial, legal and insurance, and now in life sciences, is to create an open, transparent and yet confidential infrastructure to reap the many benefits of that explosive growth. For example, by digitizing R&D, lifecycle management, and real-world evidence data in a secure and trusted manner, we can identify the right patients at the right time for a given treatment, while maintaining trust and privacy for all stakeholders. We can also enhance patients’ ability to manage, engage and control how their data can be used to further innovation or advance the availability of treatments.”
Synchrogenix President Kelley Kendle
Synchrogenix has already developed a proof of concept (POC) in industry supply chain management in collaboration with Hedera. This POC is centered on the global challenge of drug shortages, which have recently been prominent in the news due to a number of quality and supply issues. This type of near-real time information availability and transparent flow of critical supply data is vital for informed risk management and better responsiveness to stakeholders. The life sciences industry is premised on creating treatments and making them readily available to the people who need them.
“Regulators around the world, including those I have worked with at the Food and Drug Administration and Centers for Disease Control and Prevention, are openly embracing the use of advanced technology to progress their mission. Public distributed ledger technology, particularly in the manner provided by Hedera, provides a good option for global regulators, allowing them to achieve the compliance and transparency they need in a secure, high-performance network designed for collaboration. I believe this is the future for accountable collaboration and compliance in the life sciences and healthcare.”
Synchrogenix VP of Technology and Innovation Jim Nasr
Synchrogenix has long supported the life sciences and healthcare industries by providing technology solutions for managing regulatory requirements, stakeholder communications, and transparency and disclosure requirements. For example, the company launched ClinGenuity in 2015, which was the industry’s first artificial intelligence tool to support content generation, and the extraction and redaction of critical information throughout the development lifecycle. ClinGenuity provides efficiency to meet the growing demands of information availability, personal data protection, and innovation utility.
“Highly regulated industries such as healthcare and life sciences are ripe for the accountability that distributed ledgers like Hedera can bring to their supply chain. We are delighted to be working with Certara to usher in a new era of visibility and transparency into a market that touches so many people’s lives every day.”
Jordan Fried, VP of Global Business Development for Hedera
Today, the growing need to meet regulatory requirements and protect confidentiality, while also supporting the need for collaborative research, including patient engagement and contribution, requires technology that provides speed, efficiency, and adherence to the strictest privacy requirements, while also reducing any conflicts of interest.
provides a cutting-edge solution that furthers capacity, scalability and value for the intrinsic rights of the individuals it is intending to serve. Through its unparalleled security algorithms, fairness, and speed, it can continue to build the trust and reputation of all stakeholders through information availability and communication in drug development and delivery to enhance participation and truly achieve a better treatment paradigm for all.