Compliant Applications for Automated Submission Ready Report Creation
StudyGen 360
StudyGen 360 stands for an application family in the area of regulatory study data reporting. Our clear productgoal is developing a future clinical study data platform that offers Pharma and CROs flexible options for study data collection, management and evaluation up to report creation for authorities at the push of a button.
With our StudyGen 360 product family, we offer a powerful scientific information plattform that can map the different requirements and scientific challenges in the field of bioanalytics, immunogenicity, pharmaceutical stability and archiving.
Let´s drive change in Clinical Study Reporting
Established partner for Pharma, Biotech and CROs
Developed in collaboration with leading pharmaceutical companies, StudyGen 360 allows you to automatically generate submission ready reports and approval documents within minutes. Closed-loop process management ensures the integrity of your data from data collection to report generation, eliminating the need for tedious data revalidation. This makes our solutions ideal for the creation of preclinical, clinical and stability studies, used in Pharma, Biotech or in a CRO – Sponsor relationship.
Pharmaceutical companies and CROs around the world rely on StudyGen 360 because it not only automates processes, but also ensures seamless data collaboration based on multiple data sources up to GxP-compliant automated reporting.
Report ready for future demands
StudyGen 360 is based on the features of the iStudyReporter application, which has been established in the pharmaceutical and CRO market for more than 20 years. The extended modular and cloud-based approach makes our application future-proof and thus fit for the technological change smart labs are facing today.
The application family is as flexible as your needs, both in terms of functionality and technology. Our product strategy clearly follows market requirements for “pay what you use” and lightweight cloud solutions. As a result StudyGen 360 is available as on-premise, cloud, hybrid or SaaS solutions.
Data Driven Study Management
The StudyGen 360 application family brings also enhanced functionality to meet the increasing needs with regards to data awareness and data review.
CLINICAL STUDY DATA IS KEY: especially for innovative and future oriented labs – collecting, managing and evaluating appropriate study data in compliance with the regulatory requirements will be decisive for the success of your clinical trials.
How StudyGen 360 supports your labs needs
Fast time to market
Fast time to marketReduced workload through automated, template-based report generation without time-consuming manual creation processes or data revalidation (QC checks).
Direct applicable
With regulatory-compliant, preconfigured reporting elements for all preclinical, clinical and stability studies.
Simple Application
Simple ApplicationEasy-to-use thanks to WIZARD software and user interface based on Microsoft Office applications and use of Microsoft Office applications for report generation.
Regulatory Security
21 CFR Part 11 -compliant with FDA regulations for electronic documentation, electronic signatures and human-readable archiving, traceability through versioning and audit trail.
Data integrity
Merging of data from various sources (Lims, SAP, Excel, databases and other sources) and assured data integrity throughout the process. Optimized data exchange between CRO and sponsor.
Future-proof
Ensured longevity through continuous development, the use of the latest technologies and cloud options.
iStudyReporter becomes StudyGen 360
In order to be able to adapt our solutions even more flexibly to the constantly changing requirements in the area of research & development in clinical studies, StudyGen 360 will serve as a platform for our reporting solutions in the future.
As a leading provider of report writing solutions for the life science market, our iStudyReporter is already used by 15 of the top 25 pharmaceutical and biotech companies in the US and Europe. Our StudyGen 360 platform marks the next important milestone in the expansion and development of highly specialized reporting solutions for the pharmaceutical industry.
Learn more
StudyGen 360 Reporter Bioanalytics SaaS – Bionanalytical Study Data Managment without a LIMS
Success Story Boehringer Ingelheim
up to data announces the release of a cloud-based bioanalytical report writing solution for CROs
