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

• 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

Our Vision

Our Mission• 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

Our CEO• 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

Our SERVICES

Argus

Programming

Statistic analyses

Application Support

Medidata Rave

Training

Validation

Oracle Clinical

Consulting

Arisg

Thesaurus Management System (TMS)

Remote Data Capture (RDC)

eLoader

Training • 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

Training• 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

Training• 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

Validation• 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

Consulting • 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

Data Management• 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

Oracle Clinical• 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

Oracle Clinical• 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

eLoader• 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

Drug Safety• 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

Our Expertise• 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

Our Advantages• 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

What’s Your Message?

Thank YouV.Balasubramanian

Business Consultant - Global Operations CHENNAI

Mob:+91 93805 55559Skype : bala.v6email: bala.v@lifesciencesexpertise.com