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. Company History
§ PDS is a leading provider and innovator of software solutions for Life
Sciences research and development
§ A few milestones
• More than 35 years on the market – founded by Dr. Hannes Westen
HQ in Basel Switzerland
• Added US sales office in 1986
• General Toxicology & Reproductive Toxicology modules integrated in
2001
• Added Asia Operations in 2013
§ PDS is the only software vendor entirely focused on preclinical safety

3. PDS Company Facts
§ Over 85 global “blue chip” customer sites worldwide
presence in USA, Europe, Japan
§ ISO/IQNet Certification
§ First Application Service Provider (SaaS) for preclinical LIMS
• First & Only GLP-Certified SaaS Provider
§ Staff with Preclinical work background
• Recently promoted Vicente Nogues as CEO
§ PDS invested significantly into the preclinical product portfolio
• New modules in the pipeline
• SEND as new business becomes new revenue generator (PDS is the
leader with more than 100 FDA submissions)
• Ascentos is the backbone and legitimation for the SEND business

4. PDS’ Fields of Services

5. Ascentos

6. TranSEND: Application Architecture
FDA Requirements
Legacy /
Flat File
Validation
ReportDefine.xml Define.pdf tumor.xptXPT
Harmonized Dataset
Terminology Translation
Validation (OpenCDISC/FDA)
SEND XPT
Files
SEND Adapter(s) SEND Adapter(s) SEND Adapter(s) SEND Adapter(s)
Ascentos
LIMS
l
LIMS
External
LIMS
nSDRG

7. PDS Quality Standards

8. Quality Standards Applied
§ Robust Quality Management System
§ GLP – CFR 21 Part 11 Compliant
§ ISO / IQNet Certified
§ GLP Certified SaaS (first & only one)
§ Software development and maintenance standard
§ Overall continuous improvement processes
§ AGILE development methodology
§ Active member of GxP/IT working groups
• PhUSE
• CDISC
• AGIT

9. Support and Services

10. Europe
support@pdslifesciences.com
PDS Support Centers
Europe
Headquarters
SwitzerlandNorth America
NJ
Pacific Rim
PDS Japan

11. Support
§ Support is provided by a staff of scientists with over 100 years of in-
lab experience
§ Baseline support is available 08:00 – 01:00 CET
§ Additional support can be supplied as needed (Gold Support)
§ PDS uses web-based incident tracking system and logs all support
calls centrally
§ Periodic User Group Meeting held both in US and in Europe
(dedicated German User Group Meeting under investigation)

12. Services
PDS offers many services
§ Installation and IQ
§ Implementation Planning
§ Training at all levels for all functions
§ CSV - Validation
• OQ
• PQ assistance
§ Scientific Consulting
§ SEND
• SEND Express - SEND as a Service
• Controlled Terminology Mapping
• Study Data Reviewers Guide creation
• Data Management
• Regulatory Preparation Services (SEND QC and fitness test for CRO
or in-house generated SEND datasets)

13. PDS Product Pipeline
/ Roadmap

14. Latest Products & Pipeline
• PDS continually improves all of its software
• Ascentos is the culmination of over 25’000 man-hours of effort to
improve from previous releases
• Latest modules:
§ PF – Pharmacy Formulation
§ TK – BA blood sampling
§ ImageBase (currently under testing)
§ TissueBase (additional enhancements currently under development)
§ PathData v6 data migration (upload into Ascentos)
§ New graphical outputs
• Planned:
§ Duration-based dosing (IV Infusion/Inhalation)
§ Ascentos 2.0