knowledge

Worldwide Clinical Trials selected up to data´s reporting solution “StudyGen 360” to perform bioanalytical study reports

Bioanalytik

Wörrstadt, Germany – June 15, 2023 – up to data, a long-standing supplier of report generation software for regulatory purposes, announces that it has been selected by Worldwide Clinical Trials, Inc. (Worldwide), a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications, to provide solutions for automatic generation of their bioanalytical study reports.

Aligned with its consistent growth path, Worldwide was looking for innovative IT solutions in the area of lab-automation and lab-workflow optimization. To achieve maximum efficiency and compliance with the latest regulatory requirements of the ICH M10 guideline, one focus of Worldwide is on the harmonization and automation of manually-generated regulatory reports for bioanalytical studies.

As a leader in providing report writing solutions for the Life Sciences, up to data’s flagship product StudyGen 360 is implemented by 18 of the top 25 pharmaceutical and biotech companies in the U.S. and Europe. StudyGen 360 is recognized as the de-facto standard for automated eCTD-compliant reporting from different laboratory data systems and therefore was the first choice for Worldwide.

Norbert Bittner CEO, up to data: “Our long-standing experience enables us to help our customers in achieving their ambitious and sustainable goals. The widespread use of StudyGen 360 in major pharmaceuticals and CROs illustrates the ongoing recognition of our solution as the gold standard in automated GxP-reporting”.

 

About Worldwide Clinical Trials

Worldwide is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Our capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by our accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program.

Anchored in our company’s scientific heritage, we are therapeutically focused on cardiovascular, metabolic, neuroscience, oncology, and rare diseases. Our deep therapeutic knowledge enables us to develop flexible plans and quickly solve problems for our customers.

Our team of 3,000+ professionals spans 60+ countries, and believes that through a culture that embraces diversity, equity, inclusion, and belonging (DEI&B), everyone plays a vital role in making a world of difference for patients and their caregivers. We are united in cause with our customers to improve the lives of patients through new, innovative therapies.

For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

 

About up to data

up to data was founded in 1992. It is an international provider of innovative and customizable IT solutions for the Life Sciences, pharmaceutical, chemical, and biotech industries with offices in Europe, North America, and Asia-Pacific. The company product offerings include LIMS, data review, and report writing solutions. up to data is certified by DQS for ISO 9001:2015 Quality Management Standards.

For more information about up to data, please visit www.uptodata.com or follow us on LinkedIn.

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up to data GmbH
Ulla Horst-Hassinger, Marketing Manager

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