Ascentos Preclinical Software 2019

PDS is a privately owned, Swiss-born provider of software and solutions for life sciences research and development. For more than 30 years, we’ve developed software by scientists, for scientists — a hallmark that is unrivaled in our field. For that reason, eight of the world’s top 10 pharma companies have relied on PDS software, as do industry-leading CROs, chemical companies, universities and regulatory agencies. With offices on three continents and clients spanning North and South America, Europe and Japan, we are at home globally.

2. Ascentos
Preclinical Software

3. Ascentos at a Glance
Ascentos is the best laboratory information management
solution of its class
§Tailor made software for people who use it –scientist
§Made by people who understand preclinical work flow
(not a IT solution)
§Keystroke by keystroke optimized for efficiency
§Flexible and scalable –grows with your business
§Generates reports that drive insightful decisions
§Most CDSIC SEND ready software

4. Ascentos

5. Toxicology
Designed by active toxicologists and laboratory
technical staff
§One protocol drives it all
§Effortless user-selectable randomization
§Handles cage labeling and/or transponder chips
§Easy instrument setup and connectivity
§Fast and accurate dosing
§Intelligent in-life data collection and workflow
§Fast corrections, CFR21 part 11 compliant
§User definable statistical profiles
§Very fast report generation (closed system, no SAS or Crystal
Reports needed)

6. Toxicology
§Bar-code handling
§Colony management
§Device administration
§Group housing
§Tables on demand
§Integrated historical control
data
§Laboratory instrument
interfaces
§Complex dosing regimens
§Drug administration and
formulation
§Multiple staggered starts
§Palpable mass tracking
§Toxicokinetics(TK)
§Resource management
§Support for all preclinical
study types
§User-definable balance
driver, statistics,
randomization activities
and measurements
§Integrated study monitoring
§Integrated study cost
calculator

7. Clinical Pathology
§Set quality control parameters and define session
intervals
§Quickly change animal sequencing for randomized
processing
§Work from templates to rapidly define sub-protocols
§Automated data recording with ability to develop drivers
for any instrumentation
§Integrated sample management (status, location and
condition tracking features)

8. Clinical Pathology
§Bar-code labeling
§Compliant with 21 CFR Part 11
§Data export features, including
FDA-suggested formats and
external statistics
§Data range-checking based on
age, alarms applied
§Data review and acceptance
management
§Integrated quality control
management system
§Integrated user-definable statistics
§Levey-Jennings plots
§Definable sample order (fortuity
lists)
§Fully integrated search for
historical control data
§Session-driven data acquisition
§Sophisticated data verification
algorithms
§Supports all types of short-term
and long-term studies
§Supports count data (e.g., blood
smears, bone marrow smears,
etc.)
§Template-and protocol-driven
§User-definable parameter options

9. DART
§Predefine activities (such as mating dates) or set up and
populate activities in real time
§Add and include/exclude animals in studies and reports
with a few clicks
§Designate activities, measurements and statistics for
animal study phases
§Scientists can view related activity data within data entry
screens
§Software learns as you go, knowing what needs to be
collected based on collected data
§Powerful supervision and review tools, including the
ability to flag data for later review
§

10. DART
§All data collection functionality
available in ToxData (general
toxicology)
§Changeable fetal morphology
observation ratio (e.g., 80/20 vs.
50/50)
§Definable start day (0 or 1) for
each study phase
§Staggered start
§Blind reading and reporting
§Estrous cycle evaluation
§Confirmation of mating
§Descriptive statistics
§Fully automated processing of
animal phases
§Delivery/parturition
§Sperm motility and analysis
§Fetal morphology/pathology
evaluations
§Ability to select customized
statistical profiles for each
parameter/measurement within
summary reports
§Cesarean section
§Integrated user-definable
statistics
§Supports all types of ICH studies
§Group housing
§Toxicokinetics
§Integrated historical control data

11. DART
§Study protocol templates
§User definable fetal, pup and litter activities
§Pup behavioral and development evaluation and analysis
§Robust reporting tables for pup and litter data
§Individual and summary tables
§Reports by study phase
§Robust number of reproductive indices and calculations
§Capable of multiple control group selection for comparative control for
summary reports

12. PathData –The Gold Standard in Histopathology
àFrom the Inventor of the AOFT
§Well-Organized Necropsy Operations
•Necropsy management table
•Built-in necropsy glossary
•Chip/bar-code reading
•Integrated organ/body weighing
§Eyes Don’t Even Have to Leave the Microscope
•User-friendly choice of graphical (mouse) or
keystroke input
•Function keys enable fast navigation and entry
§Fast Slide Evaluation, Correlation and Review
•Fast and safe microscopic data entry (no spreadsheet driven but
scientifically driven, designed for slide evaluation)
•Drag and drop organ findings
•Enter multiple diagnoses simultaneously
•Start where you left off when you restart sessions
•Bar-code scanning for fast logging
•Smart and flexible glossaries that learn as you go
Since 1980

13. Ascentos -Pathology
§Single Protocol
oEntry of Study parameters
§Necropsy
oEntry of necropsy findings directly into Menu-Driven module
oGeneration of Raw Data report
§Final Body Weights and Organ Weights
oEntry of weights via defined balances
oGeneration of Weighing reports with optional statistics
§Microscopic Evaluation
oOrgan List order
oReading 1-15 animals per screen
oIntegration of Clinical Pathology data and Body Weight Growth Curve
oAbility to view digital images for each animal/organ
oMacro/Micro Correlation
§Report Generation
oIAS, Incidence and Statistical Reports

14. Ascentos –Pathology -Animal Organ Finding Table
Indicator
for digital
slide

15. Ascentos-Pathology / Digital Slide Integration

16. Full Integration -ClinPath & Body Weight Curve

17. Necropsy finding with Image

18. AOFT –Organ Level Image

19. Microscopic Finding Level –Image

20. AOFT: Micro Image