医療従事者の為の最新医療ニュースや様々な情報・ツールを提供する医療総合サイト

Certara Introduces Pre-clinical Safety Store to Capture and Validate File-based Study Data in a CDISC-SEND Database

2014年04月30日 AM06:00
このエントリーをはてなブックマークに追加


 

ST. LOUIS

Certara™, the leading global technology-enabled drug development and drug safety consultancy, announced today the launch of its Pre-clinical Safety Store (PCSS). A companion product to D360, Certara’s integrated solution for the query, analysis and visualization of drug discovery and development data, PCSS enables the capture and validation of file-based pre-clinical study data in a CDISC-SEND architected database, meeting FDA recommendations for standardization of data formats for study data in regulatory submissions.

Pharmaceutical customers who pair PCSS with D360 will be able to access pre-clinical study data from contract research organizations (CROs) in minutes, in a consistent format, for study monitoring and cross-study analysis. PCSS also offers a terminology mapping tool that provides a consistent view of study data from multiple sources.

PCSS was developed in collaboration with D360 customers to address specific challenges that they were facing, such as CROs supplying their data in different file forms and using different names for the same test. PCSS uploads study data files into a SEND-based data system so that the information can be readily queried and analyzed by D360. PCSS also standardizes the naming convention used to match either CDISC-SEND controlled terminology or a customer’s own.

“Capturing study data using PCSS allows real-time study monitoring; it takes just minutes to upload and query the data and eliminates hours of complex file manipulation. That, in turn, permits rapid decision making about ongoing studies,” said Certara Chief Technology Officer Jonathan Feldmann. “Furthermore, by facilitating trend analysis of past studies, PCSS helps improve study design and drug development research.”

Certara will be demonstrating PCSS in booth #325 at the Bio-IT World Conference & Expo in Boston, MA from April 29-May 1.

About Certara

Certara is the leading technology-enabled drug development and drug safety consultancy. Its customers include hundreds of biopharmaceutical companies around the globe, together with several regulatory agencies. Certara’s solutions, which span the discovery, preclinical and clinical stages of drug development, enable data-driven decisions, leading to more precisely designed trials with a reduced risk of failure and improved subject safety. For more information, visit www.certara.com.

CONTACT

Certara
Diana O’Rourke, 314-951-3310
Director of Marketing
diana.orourke@certara.com
or
Media
Contact:

Rana Healthcare Solutions
Lisa Osborne,
206-992-5245
lisa@ranahealth.com

同じカテゴリーの記事 

  • EMS Kegel Trainer BODYDOCTOR Opens New Era of Health Care Solutions in Global Femcare Market
  • EMSケーゲルトレーナー BODYDOCTOR、Femcareのグローバル市場でK-HEALTH CAREに注目が集まる
  • InnoCare Announces Dosing of First Patient in Clinical Study of the Combination of SHP2 Inhibitor ICP-189 and EGFR Inhibitor Furmonertinib
  • METIS第3相臨床試験で主要評価項目を達成、非小細胞肺がんからの脳転移患者における頭蓋内進行までの期間を統計学的に有意に延長
  • Poxel to Report Its 2023 Annual Results by the End of April 2024