The Provantis® General Toxicology product is a modern, flexible solution that supports the toxicologist in the management, performance, analysis and reporting of all study types. It fulfils the needs of product safety studies in pharmaceuticals, agro-chemicals and contract research and satisfies all protocols approved by regulatory authorities worldwide.

Data Collection

The full range of Data Collection types are supported including:

• Clinical Observations
• Palpable Masses
• Bodyweights
• Dosing
• Food and Water Consumption
• FOB
• User Defined Measurements

This module also handles the in-life phases of a reproductive study.

Protocol Management

The protocol module allows the study director to define the protocol to Provantis, which then manages the duties of the technicians on a day-to-day basis to ensure protocol adherence. The system handles studies on any species and strain, placing no limit on the number and order of parameters measured, or the study design.

Reporting

A wide variety of table formats are available, including:

• Individual animal data tables
• Group summary tables
• Incidence analysis by animal group, symptom, severity
• Time to response
• Mass location diagrams
• Raw data and audit trail reports

Work Scheduling

One of the most sophisticated aspects of Provantis is the link between the protocol and data collection modules, which provides the automated scheduling of all animal room activities.

Labeling

Label creation is quick, simple and completely user-definable allowing you to use over 350 standard label formats (including Avery) or customize your own size and layout.

You may select fields directly from the Provantis database and incorporate objects such as graphics, text, or fields that prompt users for input prior to printing. This may include bar-coded information (25 formats) and the definition can be saved for use by others.

By using Labeling you can create any label required for the life cycle of your study such as rooms, cages, food bins, dose pots and ECG traces.

Integration

Provantis is unique in terms of integration. On any given study, all data collection modules share a single protocol and common glossary management and security structures.

• Find Out More Contact Us

---

• 

Provantis Pathology is a comprehensive, intuitive and flexible software solution that supports the pathologist in the collection, processing and reporting of data for gross and histopathology, including mass tracking and organ weights. The Provantis Pathology solution provides a consistent, familiar look and feel, seamless access to your favorite Microsoft applications and powerful, flexible reporting. Provantis Pathology is used by organizations across the globe, from single user remote Pathologists to multi-site laboratories.

Data Collection

Data collection is fast, accurate and flexible. As well as offering a choice of keyboard entry, using user defined codes, or mouse entry picking from lists, there are a wide variety of user preferences to allow you to work in the way you choose – one animal at a time – by tissue - in a matrix of animals and tissues – the choice is yours. Sophisticated completion checking prevents errors and ensures protocol adherence.

Numerous shortcuts are available to the experienced user and keyboard/mouse activity has been ergonomically reduced to a minimum.

Integration

The Pathology module is fully integrated with the rest of the Provantis suite. It shares a common protocol, ensuring all other data such as In-life, necropsy, organ weights and clinical pathology data is available to the pathologist. Provantis Pathology can also be integrated with Spotlighter™, our new Historical Data Management solution.

Reporting

A large selection of standard ready-to-publish reports are available. These feature multiple selection criteria, including page headings, animal/group selection and the option to include full or partial observation detail (eg tissues, morphology, modifier):

Summary reports - Intergroup comparison of gross/histo observations, Intergroup comparison of organ weights and organ weight ratios, Gross/Histopathology observations - animal cross-reference, Tumor summary, Combination incidence of tumors, Chronological listing of tumors, Completed animals, Cause of death summary, Incompleteness check, Major Pathological findings, FDA Biometrics report

Individual animal reports - Animal data, Gross pathology observations, Correlation of findings, Cause of death, Palpable mass diagnosis and Individual organ weights

An example of the flexibility can be seen in the intergroup comparison reports, where there is an option to show male/female-only data or combined. One of the reporting format options is to show animals by removal reason and group. Other options include animals with findings only and/or observations split by severity. For histo, the user is able to request neo and non-neoplastic observations separately or combined. Incidences can be shown as percentages or absolute. Syndromes and Merging and Include/Exclude facilities allow manipulation of the presentation of findings.

A number of animal history reports (including mass tracking from in-life, through gross to histo), raw data and glossary reports are also available.

Latest Features

New functionality includes:

• Advanced Matrix entry – allowing even faster data entry directly in the matrix
• Direct, automatic inclusion of pathology data into protocol and reports
• Enhanced Completion checking
• Simplified Glossary definition and maintenance
• Automatic production of histology labels from Protocol to Labeling module
• Remote Pathology allows offsite slide reading with full In-Life/Gross information

• Fact Sheet Download
• Find Out More Contact Us

---

• 

Instem's Clinical Pathology solution is based on the Provantis® Clinical Pathology product. This product provides bench-level functionality for the collection and processing of Clinical Pathology data, as well as further ‘Supervisor’ review, amend and release options to ensure quality results are released back to the study.

Quality Control material can be defined, maintained and used throughout the system to check instrument performance prior to and / or during animal data collection.

The system is driven by the protocol entered in the General Toxicology product, directing sample collection in the animal room and subsequent analysis within the Clinical Pathology laboratory. This level of product integration ensures there is no need to re-enter protocol details. Ad-hoc study samples may also be run as required.

Clinical Pathology specific reports are held within the ‘Supervisor’ module and provide:

• Analytical ‘run’ reports to mimic instrument data print-outs
• Study based animal result and sample raw data reports
• QC based raw data and historical analysis reports

Final study reports are provided from the Provantis Tables & Statistics module and integrate Clinical Pathology data with all other study data

Key Features

• Configurable instrument interfacing software (uni and bi-directional)
• Clear spreadsheet style layout of result data
• Real time display of instrument data capture
• QC collection, validation and export
• Different display modes (results / exceptions) for efficient data review
• Measurement tagging for easy addition of comments and results
• Security controlled data changes
• Full audit trailing

Latest Features

• Production of sample labels (including bar-codes) through Provantis Labeling Module
• Electronic signature on review sign-off steps
• Screen lock-out facilities throughout system
• Security enhancements in data transfers
• QC lot maintenance, QC data storage and QC reports
• Randomised / Counter-balanced collection lists
• Dilution factor / audit trailing utility
• Optional additional levels of data review

• Find Out More Contact Us

---

• 

The Reproductive Toxicology product is a modern, flexible solution that supports the toxicologist and teratologist in the management, performance, analysis and reporting of all reproductive study types, including:

• ICH study types (fertility and embryo-foetal development, pre- and post-natal development and embryo-foetal development)
• Multi-generation
• Developmental toxicity
• Behavioral
• Developmental neurotoxicity

Protocol

The reproductive toxicology module is fully protocol driven. The protocol recognizes the complex, phased nature of many reproductive studies and allows activities to be scheduled relative to study, pairing, mating and littering days, generational phases and observed events or measurements. This allows technicians to easily see what activities are due on which animals. The data entry programs prompt them in accordance with this schedule.

Data Collection

The full range of data collection functions are available, including:

• Oestrous cycle assessment
• Caesarean section
• Sperm analysis
• Fetal pathology
• Pairing
• Blind reading within fetal pathology
• Evidence of mating
• Supervisor review of fetal findings
• Parturition
• Development signs
• Fate allocation
• Assignment to next generation

In addition the entire general toxicology data collection functions are provided for parental animals, litters and unidentified and identified pups.

Reporting

Reproductive toxicology data can be tabulated and analyzed in many formats, including:

• Individual animal data tables
• Group summary including various statistical analyses
• Reporting by phase
• Analysis of reproductive end-points
• Calculation of numerous indices (e.g. fertility, survival, reproductive performance, observation indices by litter and foetus)
• Analysis of pup data
• Raw data and audit reports

Latest Features

• Blind Reading in Fetal Pathology
• Supervisor Review for Fetal Pathology Findings
• Staggered Delivery Randomization
• Label Creation & Printing, including reproductive toxicology information
• New Reproductive Tables
  • Intergroup Comparisons:
    • Pup Mortality
    • Pup Bodyweights
    • Pup Bodyweights Gains
    • Litter Weights
    • Litter Weights Gains
    • Pup Developmental Markers – By Day Summary
    • Pup Developmental Markers – Cumulative Count
  • Delivery Data:
    • General Details
    • Mean Pup Counts Changes to Existing Tables
  • New Analysis Periods
    • Weight Gain Tables allow the definition of weight gain intervals
    • Pup Tables allow multiple analysis periods
  • Better Account of Reproductive Phases
  • Descriptive Statistics
    • Mean
    • Standard Deviation
    • Maximum Contributory Value
    • Minimum Contributory Value
    • Standard Error (of Means)
    • N – number of contributory values
• Reproductive Statistics
  • 1 way, 1 way mixed & 2 way ANOVA
  • Kruskal Wallis
  • Likelihood Ratio Chi-Square
  • Generalised Wilcoxon’s test for censored data

• Find Out More Contact Us

---

• 

The Tables and Statistics product generates tables and, if required, performs statistical analysis on data collected by most other products in the Provantis® family. At any point during a study you can produce tables with a variety of content and formatting options.

Tables and Statistics with its ease of use, flexibility and coverage of most of standard statistical processing, and its integration with the Protocol & Report Assembly product, can play an important role in meeting the ever increasing demand to produce faster, higher quality, secure reports.

Key Benefits

• Common table production framework for all data
• Flexible table generation options
• Standard statistics available to non-specialist users
• Faster reporting via table profiles
• Secure, validated integration with Protocol & Report Assembly

The Open Architecture

Provantis 8 introduces the new Open Architecture concepts to the Tables and Statistics product. The Open Architecture frees the user from the complexities of the Oracle database, presenting the data in a simple, industry standard, XML file and formatting the data onto the report page using the BusinessObjects Crystal Reports XI reporting tool.

Features

• Open Architecture
• Industry-standard tools - Oracle, Microsoft, SAS, Crystal Reports XI
• Statistics
• Descriptive
• Comparative
• User definable by parameter or table
• Formatting
• Flexible table formats
• Variable fonts, font sizes, paper sizes,margins
• Easily changed or added to
• Output formats Word, PDF, RTF
• Graphical or tabular output
• Ease-of-use
• One-shot reporting
• User definable table headings
• Comprehensive footnoting
• Table preview
• User chosen table content
• Dispatcher for overnight processing
• Optimised performance

Integration

Tables and Statistics is fully integrated with the rest of the Provantis family of products, as well as other commonly used tools such as SAS, Microsoft Office, BusinesssObjects, Crystal Reports XI and Adobe. You can create outputs as XML files for use by other applications, or so that you can apply your own SAS procedures. Integration with the Provantis Protocol and Report Assembly product allows you to combine tables with other contributions, for example text, graphics and spreadsheets, into a secure final report.

• Find Out More Contact Us

---

• 

DISPENSE is a comprehensive computer based system for test item control.

The DISPENSE system maintains a full record of test item usage right from the initial receipt through formulation/dispensing activities to disposal.

DISPENSE makes extensive use of bar code identification and on-line electronic data capture from balances to ensure the highest level of data integrity.

Test Item Receipt

On receipt, the test item is logged into the DISPENSE system by completing a series of on-screen forms. Some information is mandatory such as name, batch number and expiry date. When all the details have been registered, each container is then assigned a unique barcode by Dispense and labels produced.

• All test substance containers carry a unique bar coded label
• The test substance expiry date prevents it from being used in a formulation after expiry
• All receipt amendments are audit trailed
• Gross test substance container weights may be recorded on-line

Formulation Specification

Formulation instructions are entered into DISPENSE on a per study or project basis and each test substance batch is linked to a study or project. The formulation specification includes details of the test substance to be used, concentration, vehicle and formulated volume (or weight). Following completion of a formulation specification, bar coded labels are printed for all formulation containers.

Formulation options include:

• solutions / suspensions (mg/ml)
• solutions (%)
• capsules (mg)
• dietary formulations (mg/kg)

DISPENSE uses a formulation matrix which covers the requirement for multiple test substances and/or multiple vehicles for some projects.

Formulation Preparation

Formulation activities are controlled by DISPENSE. The bar coded labels on all formulation containers and vehicles are used to verify each step in the formulation process. The information on each formulation container label includes the project number and the dose group.

DISPENSE:

• calculates the amount of test substance and vehicle required for each formulation
• ensures that correct weights of test substance and vehicle are used
• records all weights on-line

After entering a study or project number, you are prompted throughout the preparation process to carry out weighing procedures according to the project formulation details. Balance readings are recorded on-line. Only balances that have previously been identified to the system may be used. Identifying the balance includes specifying the balance serial number, a description of the balance, and the number and values of the check weights to be used before any weighing may be carried out on the balance.

Accountability

DISPENSE requires the formulator to weigh the bulk test substance container before use on each formulation occasion (Start of Day Accountability). The bulk test substance container is then weighed following completion of formulation work (End of Day Accountability). DISPENSE calculates the theoretical usage of test material and compares this to the actual usage to produce an Accountability Report. Any discrepancy has to be accounted for by the formulator entering an appropriate reason into DISPENSE.

Reports

A variety of reports on test substances and projects may be generated. These include Test Substance Receipt, Formulation Specification and Accountability reports. Both standard and custom reports can be produced.

Security

Access to all areas of DISPENSE is controlled by a user ID password. Each user is assigned an ID and set of access privileges to the application. This means, for example, access to enter formulation specification details can be assigned to some users and not others.

• Find Out More Contact Us

---

• 

Instem provides a range of reporting products and services to enable our customers to derive the maximum value from their preclinical data. The Provantis® family of products provides a comprehensive set of standard tables for raw, individual animal and summary data, for numeric and observational data, and for in-life, clinical pathology, necropsy and pathology data.

Provantis is integrated with the industry standard SAS statistical analysis tool. Predefined analyses, including a complex decision tree, can be used and summary tables annotated with the results of the analysis. Customers can also use the full power of SAS to define their own analyses.

Instem also provides a Business Objects Universe that provides simple access to the complex Provantis data structures. The powerful and easy to use Business Objects tools can be used by end users to create their own ad hoc queries or unusual table designs. Instem also provides services to users who wish to create more complex tables.

The final product of preclinical study is the study report. This draws together a description of the study conduct, summary and individual data tables, statistical, and possibly graphical, analyses, and scientific conclusions. The Provantis Protocol and Report Assembly module allows customers to create study reports as Microsoft Word documents in a secure environment by combining tables and analyses produced by other Provantis modules, and outputs from non-Provantis systems (eg Microsoft Excel). All contributions to a report can be automatically reformatted as required, whilst at the same time protecting the integrity of the data. Users can develop their own formatting macros or use Instem services if they prefer.

Finally Instem has used its extensive knowledge of preclinical data and data collection systems to help customers create Data Marts for specific purposes such as historical data, and Data Warehouses as more general repositories of preclinical data.

• Find Out More Contact Us

---

• 

Introducing Spotligher™ - a new, stand-alone, web-based software solution for historical data management, enabling you to store, retrieve, and evaluate histopathology data across studies in control and treated animals

It is an easy-to-use, value-added solution for toxicologists, pathologists and study directors, which requires no database or datamining expertise. Spotlighter provides analytical outputs directly interpretable by scientists, which can support their argumentation whilst writing their report.

Spotlighter uses APIs to extract control and treated data from a wide variety of data sources including SEND datasets and data collected in preclinical data management solutions such as Provantis and Ascentos.

Key Benefits of Spotlighter

• Provides control and reference data requested by regulatory authorities.
• Delivers fast, practical answers on typical questions arising during toxicology & pathology studies.
• Provides summary reports and identifies patterns in your data.
• Supports read-across between studies.
• Uses historical data to gain insight into potential mechanisms.
• Supports pooling of historical data to support statistical analyses.
• Supports virtual control groups.

Find Value in Your Data and Save Time

Extracting relevant information from historical data can take days of research. With Spotlighter you can get the answers you need in minutes.

• Spotlighter combines all reference data into one comprehensive system, removing the need to work from multiple spreadsheets, formats, and data sources. The result is faster turnaround times and fewer manual errors.
• Easily identify patterns in your data and quickly gain insight into potential mechanisms supported by other research.
• Avoid spending time processing background noise by using Spotlighter to quickly highlight which of your results have significant, treatment-related findings.

Spotlighter can be purchased as a standalone solution, or as part of our Provantis preclinical data management solution.

• Fact Sheet Request PDF
• Find Out More Contact Us

---

• 

Data Exchanger™ is a value-added software solution that enables clients to quickly and securely import data from a wide variety of external sources into Provantis.

Data Exchanger is the next generation of our Data Import solution, providing enhanced functionality and increased flexibility that enables users to import a wider array of additional, complex data types such as:

• SEND and Observational data
• Estrous Cycle and Clin Path data
• Bone Assessment data
• Gross Pathology and Palpable Mass data
• External sample analysis
• & More!

The intuitive Data Exchanger solution imports data through a secure, validated process, complete with comprehensive audit trails and data flagging capabilities.

Key Features that Deliver Clear Benefits

• Allows import from a wide array of file types including Excel, CSV, Access, Text, Binary and Xml, enabling you to import data from all your data sources
• Supports the import of SEND data sets - Using Instem's submit™ solution you can create and exchange SEND data sets between Sponsors, CROs and other collaborators and import the data into Provantis using Data Exchanger
• Supports numeric and textual data - Unlike many other import tools which only support numeric data, Data Exchanger also allows you to import text based, observational data
• Supports animal, cage and study level data entry, enabling you to import data at multiple levels
• Users can review, amend, flag and delete data during import, giving you complete control over which data is imported into Provantis
• Data Exchanger is fully audit trailed, giving you complete visibility of how source data entered Provantis and any changes and selections that were made
• Data Exchanger's flexible, intuitive user interface allow you to quickly and easily configure imports  
• Single-click file import enables rapid data entry
• Supports live and retrospective data entry - You control which timestamps are assigned to data, enabling you to indicate whether data was collected live or retrospectively
• Supports the import of multiple files as a single unit, enabling you to import multiple files to describe a single experiment or set of data, such as SEND data sets
• Calculations can be performed on the imported data, enabling you to store values derived from the raw data in Provantis

• Find Out More Contact Us

---

•