Solutions for Study Data Management and Reporting

StudyGen 360

The StudyGen 360 product family is a powerful scientific data platform for the management of clinical trial data. It 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.

Various StudyGen modules support the different requirements and scientific challenges in the areas of bioanalytics, immunogenicity, pharmaceutical stability and archiving.

StudyGen 360 is a cloud-based, scalable, pay-per-use application that ensures end-to-end data integrity for your clinical trials. All study-relevant information is collected in a centralized data repository without the limitations of a conventional LIM-System. This innovative cloud-based data management approach provides end-to-end data compliance from sample collection to the final study report.

Manage all study-relevant data in a central data repository and benefit from new approaches to analyze and compare your study data over the entire course of your study according to scientific criteria and requirements.

StudyGen is the right solution for all Pharma, Research and CRO companies, especially designed to optimize the collaboration in a Sponsor-CRO relationship.


Sample Management

Bioanalytical Study Data Managment without LIMS

Bioanalytics SaaS

Automated Bioanalytical Reporting without LIMS

Bioanalytics Watson

Automated Bioanalytical Reporting based on Watson LIMS


Automated Stability Study Reporting based on LIMS data


Long term archiving of Watson Study Data

Let´s drive change in Clinical Study Data Management

Established 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.

StudyGen 360 supports your Clinical Trial

Fast Time to Market

Reduced workload through automated, template-based report generation without time-consuming, manual creation processes or data revalidation (QC checks).

Direct Applicable

Regulatory-compliant, preconfigured reporting elements for all preclinical, clinical and stability studies.

Simple Application

Easy-to-use thanks to WIZARD software and user interface based on common applications, 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 others) assures data integrity throughout the process. Optimized data exchange between CRO and Sponsor.


Ensured longevity through continuous further development, 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, iStudyReporter is already used by 15 of the top 25 pharmaceutical and biotech companies in the US and Europe. StudyGen 360 platform marks the next important milestone in the expansion and development of highly specialized reporting solutions for the pharmaceutical industry.

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