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.


StudyReporter Bioanalytics Watson

Automated Bioanalytical Reporting based on Watson LIMS

StudyReporter Bioanalytics SaaS

Bioanalytical Study Data Managment without a LIMS

StudyReporter Stability

Automated Stability Study Reporting based on LIMS data


Long term archiving of Watson Study Data

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

Reduced 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

Easy-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.


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.

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StudyGen 360 Reporter Bioanalytics SaaS – Bionanalytical Study Data Managment without a LIMS

Subscription-based regulatory reporting for pharmaceutical studies, designed with CROs and smaller research labs in mind. more »
Product Flyer

Success Story Boehringer Ingelheim

Learn how Boehringer Ingelheim successfully converted their bioanalytical reports to automated reporting in a very short time, and the challenges the world's leading pharmaceutical company faced. more »
Data Integrity
Success Story

up to data announces the release of a cloud-based bioanalytical report writing solution for CROs

A subscription-based, affordable solution that eliminates upfront implementation costs generating immediate value. more »
Press Release

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

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.… more »
Press Release