iStudyReporter

Pharmaceutical companies face the challenge of making the approvals process more efficient, speeding up official approvals for pharmaceuticals, and bolstering market position and competitiveness.

iStudyReporter is a unique solution aimed at extremely efficient approval document creation for pharmaceutical companies while significantly reducing errors, streamlining approval procedures and cutting the time required.

iStudyReporter solution

iStudyReporter is an innovative standardised product family that automatically generates complex study reports and approval documents from a whole variety of data sources within a matter of minutes. These documents are compliant with all of the international regulatory, the tool ensures data integrity and statutory requirements including all of the necessary graphics and statistical analyses.

up to data developed the iStudyReporter product family together with leading international pharmaceutical companies. These solutions are compatible for integration into existing IT environments with almost real-time data transfer from all of the major LIMS, ELN, CDS, ERP (SAP), MES and similar software solutions. Tables, graphics, statistical diagrams, trend reports, QC charts, and similar are all customisable to corporate guidelines using iStudyReporter, with full data integrity build-in and thus completely eliminating the need for time-consuming processes such as intermediate manual steps and QC checks.

iStudyReporter product family benefits

  • Automates lab procedures from creating approval documents to submission
  • Implements full data integrity for submission documents
  • Eliminates the need for manual steps and time-consuming intermediate procedures in creating approval documents
  • Reduces reviews to content, eliminating the need for data verification
  • Simplifies and streamlines the entire approvals process
  • Increases data security and traceability
  • Integrates seamlessly into existing IT and application environments
  • Generates more approval reports in a given time window

iStudyReporter product family features

  • Remote Collector queries all of the data sources available for relevant information while maintaining complete transparency and validity.
  • iStudyReporter uses the data collected and automatically generates complex documents within minutes at the click of a mouse.
  • The documents are based on a variety of MS Word templates according to purpose and recipient, and include additional text blocks and information such as study data and titles. 
  • iStudyReporter also provides predefined configurable tables and graphics for generation in a template.
  • The tables generated are transferred into a template.
  • Template management simplifies the process of handling different templates from study sponsors.
  • Continuous versioning management in iStudyReporter eliminates the need for additional checks and reviews.
  • An audit trail ensures consistent change tracking in approval reports.

At a glance

iStudyReporter comes with a distinct set of features, that enable the application to efficiently create complex study documentation and a document life-cycle with full data-integrity:

Word template based document generation

Wizard based setup of document content

Predefined and configurable tables and statistical evaluations (bioanalytics, stability)

Protected data areas to ensure data-integrity and avoid revalidation of each document

Freely commentable and revisable

Versioning with audit trail and eSigs

Word template based document generation

The tables choosen in the wizard selection are inserted into a Word template (defined by the customer) and protected against manual changes (optional).
This eliminates the need for repeated validation of data tables and ensures data-integrity in such documents.
Despite the protection of the data areas, all remaining sections of the document can be revised manually.
With each new version, all manually inserted text is transferred to the new version of the document - only the protected data sections are updated with the most current data.

Wizard based setup of document content

Report content is dynamically determined by the data in the underlying LIMS. Necessary general information on what data needs to be retrieved (e.g. study to be reported, storage conditions, experiments and analyses performed) is defined using a wizard. The definitions can be changed from version to version (audit trail). New reports can be created based on existing reports.

Predefined and configurable tables and statistical evaluations (bioanalytics, stability)

The elements to be inserted into a document (tables, graphics, statistical evaluations) can be selected in the wizard from a predefined list. The content is inserted in the document created at the positions provided for this purpose in the template.
Tables and graphs are predefined for the specific purpose of the document and are populated with data according to the underlying LIMS (e.g. tables are created automatically for each storage condition or each combination of analyte/species/matrix).

 

Protected data areas to ensure data-integrity and avoid revalidation of each document

The inserted tables rotected against manual changes (optional). This eliminates the need for repeated validation of data tables and ensures data-integrity in such documents.
Despite the protection of the data areas, all remaining sections of the document can be revised manually.
With each new version, all manually inserted text is transferred to the new version of the document - only the protected data sections are updated with the most current data.

Freely commentable and revisable

The inserted tables rotected against manual changes (optional). This eliminates the need for repeated validation of data tables and ensures data-integrity in such documents.
Despite the protection of the data areas, all remaining sections of the document can be revised manually.
With each new version, all manually inserted text is transferred to the new version of the document - only the protected data sections are updated with the most current data.

Versioning with audit trail and eSigs

Reports, created documents and templates are stored version controled. An audit trail ensures that the traceability of changes. The implementation of eSigs ensures the use of the system within the framework of 21CFR11.

iStudyReporter product family

Bioanalytics

Gives you an efficient solution for generating bioanalytical study reports using Thermo Scientific™ Watson LIMS™.

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Stability

Gives you an integrated solution for simple and fast approval report generation using a stability LIMS such as Sample Manager, LabWare, LabVantage.

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RemoteCollector

Gives you a unifying solution for generating complex study reports from a variety of data sources.

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Customer references

"One of our constant aims at Biotest is to optimise processes towards speeding up our development processes and keeping our edge on the competition, and iStudyReporter Stability has proven to be a valuable contribution towards using the SAP system in our lab to its fullest potential. This solution ensures really thorough stability data management."

Dr. Christoph Apel, Head of stability studies, Biotest

Success Story

Biotest

"We’ve never managed a software project with the smoothness and professionalism of up to data support. […] Many of the specific requirements were already included as standard, making for especially speedy process implementation."

Dr. Martina Wein, LIMS project manager, Boehringer Ingelheim

Success Story

Boehringer Ingelheim

“When you use iStudyReporter, you’ve got to think outside the box relative to conventional approaches to reporting. We’re not talking any more about individual reports, but rather complete approval documents that we’d otherwise never be able to generate so quickly. The solution provides us with turnkey stability documents that can be commented on individually and also meets all data integrity requirements.”

Eric De Maesschalk, Head Global e-Analytics, Corporate Analytical Sciences, UCB Pharma GmbH

Success Story

UCB Pharma GmbH

"iStudyReporter allow my team to only focus on scientific and added values sections when issuing a report and totally remove all activities related to the edition of the document itself (data table, trend chart, …)“.

François Delcroix, Stability & Critical Materials Manager / Corporate QC Support, UCB Pharma GmbH

Success Story

UCB Pharma GmbH

Do you have any questions about iStudyReporter?

Need more information, or would you like to arrange a meeting with us?

We would be pleased to help you out, and would welcome the opportunity to talk to you.

Experience delivers Excellence

up to data is specialized in high-quality IT services. The company offers a comprehensive portfolio of services - from consulting and design to the development of customized software solutions and customized laboratory information and management systems to the secure operation of the IT infrastructure, based on individual service level agreements. up to data has more than 25 years of experience in the life science, pharmaceutical, chemical and biotech industries and serves well-known companies in Europe and the USA.

Quality

up to data is certified by DQS to the following standards: ISO 9001:2015 (Certificate-Reg.No: 272524 QM15)

Besides the implementation of the above-mentioned ISO-Standards, and as the result of many years experience, we are especially aware of the standards and regulatory guidelines that our customers need to conform to. In the laboratory environment these include, among others, GAMP-Guidelines and the GxP-Standards.