The Standard report solution for Thermo Scientific™ Watson LIMS™

StudyGen 360 Reporter Bioanalytics

As an Watson LIMS add-on for over twenty years now, iStudyReporter and its successor StudyGen Reporter Bioanalytics is the de-facto gold standard for generating regulatory reports for any type of bioanalytical study from Watson LIMS.

15 of the 25 TOP pharmaceutical companies and leading CROs already successfully use StudyGen Reporter for their report generation.

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The Standard Reporting Solution for Watson LIMS

Whether bioanalytical, clinical or validation studies, for small or large molecules based on LCMS, LBA or immunogenicity measurements. Regulatory bioanalytical documents in line with ICH M10, such as validation and clinical reports can be created easily and quickly, completely eliminating manual steps, manual table formatting, and complex data revalidation checks to ensure data validity.

To meet the specific demands of heterogenous large labs StudyGen Reporter Bioanalytics provides a high degree of interoperability to offer maximum flexibility for data collection and processing from multiple systems (LIMS, ELN, SDMS, MS EXCEL etc.).

Increase the efficiency of your study report generation workflows for regulatory approval, accelerate your laboratory processes and subject them to regulatory requirements especially with regards to the new ICH M10 guideline.

Check out StudyGen Reporter Bioanalytics on Watson LIMS

  • Start Reporting Wizard and select REPORT TEMPLATE.

  • Select Project and choose appropriate Study as a next step.

  • Select a SET OF EXPERIMENTS to be included from a predefined list.

  • You could make use of our MATCHING OPTIONS and OVERWRITE NAMING STANDARDS in case it is needed.

  • Work on your OUTPUT FORMATS (number of columns, table protection, DTA to be included…) and choose your LAYOUT OPTIONS (SigFix, Decimal places, Ratio, Intra-assays, MRD…).

  • Create your REPORT DOCUMENT

  • Make use of Check-OUT functionality and define your APPROVAL CYCLE

Analytical Report, Tox Report, Validation Report, ADA Report, ADA Validation Report

Selection of GxP-Reports and Tables

Learn more about Clinical Data Management and Reporting

Contact us today and get your individual demo.

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Mature your Watson LIMS

StudyGen 360 Sample Reconciliation

Advanced sample reconciliation functionalities for Watson LIMS

Sample reconciliation plays a pivotal role in maintaining data integrity and ensuring the validity of analytical results. It involves tracking and accounting for each sample at every stage of analysis, including sample receipt, storage, preparation, analysis, and disposal. By accurately documenting the sample journey, researchers can trace any discrepancies, identify potential errors, and maintain confidence in the data generated.

In case your sample labelling is inconsistent, the StudyGen 360 Sample Reconciliation tool offers various matching options to take corrective measures. By interfacing directly with Watson LIMS, you could detect the affected sample by selecting the appropriate study information from your Watson LIMS Database. Choose the concerned sample and change the appropriate defaults without adjusting the original data in the Watson LIMS database. Your sample modifications will be executed, fully tracked and audited from and in our StudyGen 360 system. Furthermore an appriopriate Sample Reconciliation Table is generated and included in your GxP-report automatically by the push of a button.

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TOP studygen Bioanalytics functions für Thermo Scientific™ Watson LIMS™

Predefined report types

Different off-the-shelf tables for specific data preparation and presentation of data from different study types:

  • BA study report for small or large molecules

  • BA validation report for small or large molecules

  • ADA BA study report

  • ADA validation report

  • PK/Tox report

  • ICH M10 and FDA MV regulation compliant BA study report

Direct connection

  • Excel

  • Sciex Analyst© Software

  • Thermo Fisher™ Watson LIMS™

Digital report transmission (SEND)

Through an export interface, data can be digitally transmitted directly in the CDISC “Standard for Exchange of Nonclinical Data” (SEND) based on created submission reports. Secured by eSigs and audit trails for complete control over your processes and traceability.

Integrated “Document Life-Cycle with Version Management

  • Full version control

  • All modifications are tracked and audited

  • Transparent document release

  • Configurable document workflows

  • Detailed assignment of rights at group and person level

  • Integrated notification functions

Support of different output formats

  • Word
  • Excel
  • Pdf

Ensured compliance, data integrity & efficiency

Your advantages

100% data integrity

Fully automated solution with direct LIMS integration

Validated Thermo Scientific™ Watson LIMS™ Interface

Support of all data domains and study types (LCMS, LBA and Immunogenicity)

Implementation of all requirements of 21 CFR Part 11

Preconfigured reports according to the requirements (as of 2021) of ICH M10 and the FDA Guidance (MVA) of 2018, incl. optional reporting of failed runs

Prequalified tables and graphs

Preconfigured for all bioanalytical analysis types and experiments (toxicology, clinical analyses, validation experiments)

Configurable solution with support for a wide range of templates

LBA/LCMS (tox, clinical, small and large molecule validation template), immunogenicity (clinical validation template).

Time saving & clarity

Workflows for optimized support of CRO-sponsor collaboration (DTA and “Sample Reconciliation”)

Your contact person

Debbie Schmidt
Customer Engagement Manager studygen

t + 1 732 417 3601  
e sales@uptodata.de