This document describes the services offered by Life Sciences Expertise, a company providing consulting, training, validation, and software development services to pharmaceutical, biotech, and CRO companies. They offer services in data management, pharmacovigilance, training, validation, application support, and more. Their team has over 20 years of experience working with life sciences applications and processes. They conduct on-site, web-based, and public training sessions customized to their clients' needs.

1. Life Sciences Expertise
9, rue Robert Kieffer - 67800 Bischheim - France
Phone: +33 (0)6 07 32 83 85
email: info@lifesciencesexpertise.com
Website: www.lifesciencesexpertise.com

2. • With more than twenty years of
experience we propose our services
– to pharmaceutical companies, biotech and CROs
– for human health and animal health
– providing consulting, training, validation
services, software development
– in data management and pharmacovigilance

3. • Conduct training sessions and workshops (on-site,
web-based or in our training center) for Data
Management and Pharmacovigilance applications,
processes and regulations
• Develop customized training material and e-learning
• Develop validation packages for Life Sciences
applications, execute test cases, create, test or
evaluate applications
• Provide application support

4. • With a background of mathematician and software
developer specialized in security of computer
systems and optimization, working in the
pharmaceutical industry since 15 years providing
training, validation, consulting and support services
for Life Sciences applications and business processes
to pharmaceutical companies, medical devices
companies and CROs of any size worldwide
• She founded Life Sciences Expertise in 2011 in order
to share her experience in Data Management and
Drug Safety

5. Argus
Programming
Statistic analyses
Application Support
Medidata Rave
Training
Validation
Oracle Clinical
Consulting
Arisg
Thesaurus
Management
System (TMS)
Remote Data
Capture (RDC)
eLoader

6. • We conduct training sessions for:
– Oracle Clinical, Remote Data Capture (RDC),
Thesaurus Management System (TMS)
– eLoader
– Medidata Rave
– Data Management Processes
– Argus
– Arisg
– Drug Safety Regulations
– PPD Patient Profiles
– SQL, PL/SQL, MySQL
• Training and workshops may be
conducted on-site in your office,
or in our local training center, or
per web

7. • Training sessions may either be using our standard
set of training material based on CDISC standards or
customized based on client processes and standards
– Our Training material include slides, practical
exercises and Study CRFs
– All material is created in English, however in
order to facilitate the learning process we
propose trainings in English, French and German
• We organize workshops to provide either advanced
training, or help you to define or improve your
processes
• We develop Life Sciences applications’ training
material and e-learning training modules for you

8. • Our eLearning solution may be used by your team for
different purposes:
– Initial training and overview of the system
– Advanced training for users who need more
details about one specific topic
– Refresh training for activities that are not
completed frequently
• It is fully customizable:
– You may want to incorporate process and SOP
trainings

9. • We develop validation packages for Life
Sciences applications or for patches to be
installed:
– Create Validation Plan, User Requirements, Test
Cases, Traceability Matrix
– All these documents are produced in accordance
to the client SOPs and Templates, or may match
our own standard in order to be potentially
customized for you
• We execute Test Cases during your Validation
process
• We review Test Case execution to ensure all
steps have been documented
• We can test and evaluate your new applications
in order to help you to decide which tool is the
most appropriate for your process or project

10. • In addition to our Training and
Validation services we propose
Consulting Services:
– Improvement of Processes
– Optimization of the usage of your Life Sciences
Applications
– Implementation of CDISC Standards
– Development of SOPs and Working Instructions
– Application Support
– Technical and installation assistance
– Statistical analysis
– Programming
– Data Migration

11. • We are specialized in Data Management activities
and propose a wide range of services to help you to
improve the performance of your team and the
quality of your data
– We develop training material and e-learning modules for Data
Management applications or processes
– We conduct training sessions and workshops in your office, in
our training center or per Web
– We provide guidance to implement the CDSIC Standards
– We develop Data Management SOPs and Working Instructions
– We provide consulting and application support for Oracle
Clinical, RDC, TMS, eLoader and PPD Patient Profiles
– We test and evaluate Data Management applications or
patches or any external software you wish to implement
• We can develop your standard reports or Study
specific queries for your Data Management database,
either as SQL listings or as graphs

12. • The large experience of our team with
Oracle Clinical allows us to provide a
wide variety of services:
– During the past fifteen years we have been
working with different Pharmaceutical
companies, Medical Devices companies and
CROs, from the smallest to the largest, located
on any continent
• To share this experience with you, we
propose our services at any stage of
your utilization of the Oracle Clinical
Suite
• We provide on-line application support
for OC and RDC Users

13. • We can help you to evaluate whether Oracle Clinical
matches your business needs
• We create SOPs and Working Instructions
• We provide consulting to ensure you are using OC on
an optimal way
• We create your Global Library, and provide
recommendations to use OC in accordance to the
CDISC Standards
• We train your staff and Site Users, or create
customized training material for you
• We create Validation Test Cases for the
implementation of OC, a new release or a patch
• We support your validation effort
• We setup Oracle Clinical studies, including validation
procedures (edit checks), SQL scripts and database
reports, processing of Batch Data Load files

14. • eLoader is an application allowing to facilitate
and automate the Batch Data Load into Oracle
Clinical
– You can use it to upload external data like Laboratory results
– Or to import to OC data initially collected in a different
application
• We provide training sessions to help you to use
eLoader on the best way
• Our Consulting Services related to eLoader include
the following:
– Develop customized training material for eLoader adapted to
your business processes and usage of eLoader
– Validate and Support Validation of eLoader
– Define SOPs and Working Instructions
– Map eLoader with your Oracle Clinical studies to perform
Batch Data Load
– Convert and upload data collected in a different database to
OC
– Provide application support

15. • We provide consulting services for Pharmacovigilance
applications and applicable regulations:
– We develop training material and e-learning modules for
Pharmacovigilance applications or processes
– We conduct training sessions and workshops in your office, in
our training centres or per Web
– We provide guidance for compliance with Regulations
– We develop SOPs and Working Instructions for your Drug
Safety activities
– We provide consulting and application support for Argus and
Arisg, including the functional, technical and regulatory part
– We migrate data to another Pharmacovigilance system
– We test and evaluate your Drug Safety applications or patches
or any other external software you wish to implement
• We can develop your standard reports or specific
queries for PSURs or Signal Detection activities,
either as SQL listings or as graphs

16. • All services we provide is the result of
many years of experience dealing with
different companies and adjusting our
work to the client expectations
• Our goal is to share our knowledge
with you and to ensure that we help
you to improve your processes
• Produce a high quality work as fast as
possible is our priority

17. • The small size of our company
guaranties our flexibility at reasonable
rates
• Our reliable network of partners allow
us to extend our services anywhere if
needed
• We propose our services locally from
our two offices in Europe {France,
Strasbourg} and Asia {India, Chennai}
to facilitate the relation with our
customers

18. What’s Your Message?
Thank You
V.Balasubramanian
Business Consultant - Global Operations
CHENNAI
Mob:+91 93805 55559
Skype : bala.v6
email: bala.v@lifesciencesexpertise.com