Data integrity, bioanalytics, report generation, automation, Sciex Analyst, Microsoft Excel

Lack of data integrity in report generation without LIMS

The typical data workflow in a bioanalytical laboratory without a further, downstream system (LIMS) and with e.g. Sciex Analyst software for measuring raw data is characterized by the creation and control of Excel files.

Study planning, run planning, data review, data analysis, and report writing are based on data that are usually copy-and-pasted from each other:

Report generation using Sciex Analyst software usually looks like this:

(1) Sequence files are created based on a study design (sample demographics). The sequence files are transmitted to the analyst workstation and processed there (samples are measured) (2). The raw data is stored by the Analyst Workstation (Sciex Logo) in binary format (3). For further processing, result data are generated as data export files in Excel format (Excel Logo) (4). Using macros or copy & paste, the data is then reviewed in additional sheets, results tables are created and statistical analyses are calculated (5), and finally the results tables are transferred to a Word template to create the final report (6).

At each step of the workflow, there is a risk of inadvertently changing data, with a possible direct impact on regulatory outcomes. Data integrity can only be guaranteed here by manually checking the data at each step.

Data management for report generation - with full data integrity

studygen for bioanalytics without LIMS

studygen was developed to streamline this reporting workflow and eliminate manual review steps.

An optimized workflow using studygen is as follows:

  1. Sequence files are created based on a study design (sample demographics). The Sample Demographics are loaded into the software

  2. The sequence files are transmitted to the analyst workstation and processed there (samples are measured)

  3. Raw data is stored by the Analyst Workstation (Sciex Logo) in binary format and loaded into the software

  4. studygen creates a “submission-ready” report or SEND file from the provided data without losing data integrity – the report does not need to be revalidated.

Efficiency, data integrity & assured compliance

Your advantages

Automation

Automated solution with full data integrity independent of specific instrument and/or LIMS software

Flexibility

Data import from various data sources (Analyst, SoftMax Pro, …, Excel, PDF, CSV, Oracle DB, SQL Server, …)

Compliance

Implementation of all requirements of 21 CFR Part 11, preconfigured reports according to the requirements of ICH M10 and the FDA Guidance (MVA) of 2018, incl. optional reporting of failed runs

Prequalified tables and graphs

For all types of bioanalytical analyses and experiments (toxicology, clinical analyses, validation experiments)

Advanced template editing functions

Integrated layout editor for different templates according to specific sponsor requirements

Time saving & clarity

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

TOP studygen Bioanalytics without LIMS functions

Data Management

  • Study documentation incl. Sample Demographics
  • Data import from Sciex Analyst (RDB, WIFF, XML), SoftMax Pro, Excel or customer-specific LIMS
  • Flexible assay configuration

Data Review

Transparent access to raw data

Reporting

  • Graphical Report Template Builder (Excel-like math & stats.)
  • Word Document generation
  • Available table templates: tox, clinical, validation templates for small and large molecules, immunogenicity, clinical, validation templates.

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.

Support of different output formats

  • Word/Excel/Pdf

Predefined report types

Learn more

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

EDISON, NJ, USA - 07 Sep 2022 up to data announces their upcoming release of a cloud-based bioanalytical report writing solution for CROs as part of their studygen product family,… more »
Bioanalytics
Press Release

studygen raas – Reporting-as-a-Service for pharmaceutical studies

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

Your contact person for reporting in Europe

Sigrid Sander
Customer Engagement Manager studygen Europe

t + 49 6732 9490-10
e sales@uptodata.de

Your contact person for reporting in USA

Debbie Schmidt
Customer Engagement Manager studygen USA

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