Data integrity, bioanalytics, report generation, automation, Thermo Scientific™ Watson LIMS™.

Lack of data integrity in bioanalytical reports from Thermo Scientific™ Watson LIMS™.

Nearly 100% of submission reports for bioanalytical studies are prepared using Microsoft Word.

Thermo Scientific™ Watson LIMS™ offers a semi-automated reporting process for this purpose, in which data from standard masks are exported either to MS Word or, if not directly possible, to MS Excel for statistical analysis and transfer of the result to MS Word.

Even if all measures are taken in the LIMS solution environment to ensure data integrity, this is lost in semi-automated report generation. Re-verification of the report against the original data is therefore required for each report.

Automated report generation with 100% data integrity

studygen for bioanalytics with Thermo Scientific™ Watson LIMS™.

studygen for Bioanalytics replaces the complex conventional process of creating bioanalytical reports in Thermo Scientific™ Watson LIMS™ with an automated solution. Data in Thermo Scientific™ Watson LIMS™ is queried without delay. Regulatory bioanalytical documents such as validation and clinical reports can be created easily and quickly, completely eliminating manual steps, table formatting, and complex checks to ensure data validity.

studygen for Thermo Scientific™ Watson LIMS™ is the de facto industry standard for generating regulatory reports for any type of bioanalytical study – whether bioanalytical, clinical or validation studies, for small or large molecules based on LCMS, LBA or immunogenicity measurements. 15 of the 25 TOP pharmaceutical companies and leading CROs already successfully use studygen for their report generation.

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”)

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

Support of different output formats

  • Word
  • Excel
  • Pdf

Predefined report types

Your contact person for reporting in Europe

Sigrid Sander
Customer Engagement Manager studygen Europe

t + 49 6732 9490-10

Your contact person for reporting in USA

Debbie Schmidt
Customer Engagement Manager studygen USA

t + 1 732 417 3601