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

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

Certara 和 Xybion 合作整合非臨床研發軟件,以簡化藥物安全性和有效性的評估
Accesswire ·  2023/08/08 20:00

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 21and other software products.

新澤西州普林斯頓/ACCESSWIRE/2023 年 8 月 8 日/ Xybion Digital Inc.(TSXV: XYBN)(“Xybion”)是一家全球性的低代碼SaaS公司,在高度監管的實驗室實現數字化轉型,而生物模擬領域的全球領導者Certara, Inc.(CERT)今天宣佈,他們已與Xybion的Nonclinical LIMS-Pristima XD和Certara的SEND Explorer簽署了合作協議,在非臨床研發領域推出新的集成解決方案,平博 21和其他軟件產品。

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.

當今的實驗室運營正變得越來越數字化。這會產生大量可用於預測結果的數據。但是,這些實驗室中使用的孤立技術產品無法創造這種價值。Xybion 和 Certara 攜手合作,通過整合他們的產品來規劃和執行研究,管理、分析和可視化數據,從而加快藥物安全性和有效性的預測,從而消除其中一些障礙。

Leif Pedersen, President, Software, Certara, and Kamal Biswas, President & COO of Xybion signing partnership.
Certara 軟件總裁 Leif Pedersen 和 Xybion 總裁兼首席運營官卡邁勒·比斯瓦斯簽署了合作伙伴關係。

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.

Pristima XD 是臨床前 LIMS 軟件,它創建了一個端到端的數字實驗室執行環境,可以靈活地管理 GLP 和非 GLP 實驗室的各種研究類型。Certara 的 SEND Explorer 產品系列是一款一流的數據倉庫和可視化應用程序,能夠使用各種格式的非臨床研究數據,包括 SEND(非臨床交換標準)數據集、靜態電子表格格式,以及與 Xybion 的 Pristima 數據收集系統(或 Savante 數據存儲庫)的直接連接,允許組織監控正在進行的研究並可視化/查詢化合物安全性評估中正在進行的研究和/或已完成研究的數據。

"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."

Certara軟件總裁Leif Pedersen說:“我們與Xybion的合作使我們能夠幫助科學家提高他們監測、查詢和可視化非臨床研究數據的能力,從而更好地評估化合物安全性,並根據這些數據做出明智的決策。”“Pristima、Savante和SEND Explorer的綜合優勢將使組織能夠加快數據審查,從非臨床研究投資中獲得見解,支持科學好奇心,促進卓越的分析文化。”

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."

Xybion Digital董事長兼首席執行官Pradip Banerjee博士說:“我們很自豪能與Certara建立合作伙伴關係,以增強數字化能力,爲非臨床研發利益相關者提供10倍的價值。我們的組合解決方案非常及時,需要跨越不同的地理位置。我們的合作伙伴關係將在全球範圍內提供解決方案。”

Together, Certara and Xybion products provide the following capabilities:

Certara 和 Xybion 產品共同提供以下功能:

  • 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
  • 學習規劃
  • 協議管理
  • 研究執行和數據收集
  • 質量、合規性和偏差管理
  • 數據管理
  • 正在進行的研究的可視化
  • 多項研究可視化
  • 研究內部或跨研究的模式和趨勢
  • 預測監管問題
  • 支持科學合作並交流研究結果
  • 在藥物研發決策中利用歷史數據
  • 數據驗證和發送提交

"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.

“使用多項研究數據進行數據驅動的決策以及可共享的知識和見解將提高非臨床實驗室的績效。Xybion總裁兼首席運營官Kamal Biswas補充說,我們的組合技術將使這一過程變得無縫銜接,並顯著提高數據質量,從而獲得更準確的見解。

About Xybion Digital

關於 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.

Xybion 是一家全球性軟件和服務公司,致力於幫助生命科學企業組織加快新藥開發,使其成爲經批准的藥物。Xybion 將藥物研發、實驗室測試、監管批准和藥品製造數字化在一個統一的雲平台上,該平台具有成本效益、隨時可部署且易於使用。Xybion 在 29 個國家/地區擁有 160 多家客戶,他們使用其低代碼軟件來加快創新速度、提高合規性、擴大產能、最大限度地降低運營風險和減少開支,同時確保員工安全。這些模塊是統一的,創建了一個強大的實驗室執行系統,爲所有實驗室工作人員提供無縫體驗,爲 IT 組織維護一個非常簡單的 IT 生態系統。

Learn more about Xybion at

要了解有關 Xybion 的更多信息,請訪問

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

媒體聯繫人,Xybion:
約瑟夫·卡利納
Xybion Digital
609-512-5790 x 316
jkalina@Xybion.com

About Certara

關於 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 .

作爲生物模擬領域的全球領導者,Certara 使用專有的生物模擬軟件、技術和具有廣泛互補專業知識的藥物開發專家團隊來加快藥物研發速度,以改變傳統藥物的發現和開發。其客戶包括遍佈62個國家的2,000多家生物製藥公司、學術機構和監管機構。欲了解更多信息,請訪問。

Media Contact, Certara

媒體聯繫人,Certara

Sheila Rocchio
Certara
Sheila.Rocchio@certara.com

希拉·羅基奧
切塔拉
Sheila.Rocchio@certara.com

Related Links

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SOURCE: Xybion Digital Inc.

來源: Xybion Digital Inc.


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