Certara & Xybion Partner to Integrate Nonclinical R&D Software to Streamline Assessing Drug Safety & Efficacy

PRINCETON, NJ / ACCESSWIRE / August 8, 2023 / Xybion Digital Inc. (TSXV:XYBN) ("Xybion"), a global, low-code SaaS company that enables digital transformation in highly regulated labs and Certara, Inc. (CERT), a global leader in biosimulation, announced today that they have signed a partnership agreement to bring new integrated solutions in the Nonclinical R&D space with Xybion's Nonclinical LIMS-Pristima® XD and Certara's SEND Explorer™, Pinnacle 21™ and other software products.

Today's lab operations are becoming increasingly digitized. This creates vast amounts of data that can be utilized for predictive outcomes. However, siloed technology products used in these labs are not able to create that value. Xybion and Certara join hands to remove some of these barriers by integrating their products to plan and execute studies and manage, analyze, and visualize data to accelerate predicting drug safety and efficacy.

Pristima® XD, preclinical LIMS software, creates an end-to-end digital laboratory execution environment with the flexibility of managing various study types for GLP and non-GLP labs. Certara's SEND Explorer™ Product Family is a best-of-class data warehousing and visualization application capable of consuming nonclinical study data in a wide variety of formats including SEND (Standard for Exchange of Nonclinical) datasets, static spreadsheet formats, and direct connection to Xybion's Pristima data collection system (or the Savante data repository) allowing organizations to monitor in-progress studies and visualize/query data from ongoing and/or completed studies in the assessment of compound safety.

"Our partnership with Xybion allows us to help scientists to improve their ability to monitor, query, and visualize non-clinical study data to better assess compound safety and make well-informed decisions based on these data," said Leif Pedersen, President, Software, Certara. "Combined strengths of Pristima, Savante, and SEND Explorer will allow organizations to expedite data review, gain insights from their nonclinical research investments, support scientific curiosity, and promote a culture of analytic excellence."

Dr. Pradip Banerjee, Chairman and CEO of Xybion Digital said, "We are so proud to have the partnership with Certara to enhance the digitization capabilities and deliver 10x values to the Nonclinical R&D stakeholders. Our combined solutions are very timely and needed across various geographies. Our partnership will offer solutions globally."

Together, Certara and Xybion products provide the following capabilities:

• Study planning
• Protocol management
• Study execution and data collection
• Quality, compliance, and deviation management
• Data Management
• Visualizations for ongoing studies
• Multi-study visualizations
• Patterns and trends within or across studies
• Anticipate regulatory concerns
• Support scientific collaboration and communicate findings
• Leverage historical data in drug development decision-making
• Data validation and SEND submission

"Data-driven decision making and sharable knowledge and insights using multiple-study data is going to enhance the performance of nonclinical labs. Our combined technologies will make this process seamless and significantly improve the quality of data for more accurate insights," adds Kamal Biswas, President & COO, Xybion.

About Xybion Digital

Xybion is a global Software & Services company that helps enterprise life sciences organizations accelerate new drug development into approved medicines. Xybion digitizes drug research and development, laboratory testing, regulatory approvals, and pharmaceutical manufacturing on a single, unified cloud platform that is cost-effective, ready to deploy, and easy to use. Xybion has over 160 clients in 29 countries using its low-code software to accelerate speed of innovation, improve compliance, expand capacity, minimize operating risks, and reduce expenses while keeping employees safe. These modules are unified creating a robust lab execution system that provides seamless experience for all laboratory staff and a very simple IT ecosystem to maintain for the IT organization.

Learn more about Xybion at https://www.xybion.com/

Media contact, Xybion:
Joseph Kalina
Xybion Digital
609-512-5790 x 316
jkalina@Xybion.com

About Certara

Certara, a global leader in biosimulation, accelerates medicines using proprietary biosimulation software, technology, and teams of pharmaceutical development experts with broad and complementary expertise to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries. For more information, please visit www.certara.com.

Media Contact, Certara

Sheila Rocchio
Certara
Sheila.Rocchio@certara.com

Related Links

https://www.xybion.com/

SOURCE: Xybion Digital Inc.