ARITHMOS

Life Sciences

Overview

Who We Are…

Technology company specialized in tailored solutionsfor life sciences:

GxP applications and services, CSV & IT Complianceconsultancy, Clinical Data Visualization, Hosting

Capable of developing customized GxP applications

Proprietary software: Symphony EDC and ArithmosCentrum ERP

Founded in 2010, ARITHMOS has supported Pharma, Biotech and Medical Device companies, CROs and Academic Institutions

Certifications: Quality Management (ISO 9001:2008) and

Information Security Management (ISO 27001:2013)

Quality Certifications

ARITHMOS is ISO 9001:2008 certified

in the following services:

Provision of Hosting and Housing

services

HelpDesk in Windows and Oracle

environment

System support and assistance

Software application

development and assistance

ARITHMOS is ISO 27001:2013 certified

in implementing its Information

Security Management System (ISMS)

to manage:

Compliance with regulatory

standards

Data integrity, availability and

confidentiality

Business Continuity and Disaster

Recovery

PM Holding Group

CRO specialized

in clinical data

services: data

management,

biostatistics,

programming,

medical writing

and consultancy.

Est. 1992

Technology

company offering

solutions and

consultancy for GxP

applications , CSV

& IT Compliance,

Clinical Data

Visualization,

Hosting and

Enterprise Resource

Planning.

Est. 2010

Staff

recruitment

company

focused on

matching talent

with client

needs in the

Life Sciences

sector.

Est. 2012

Clinical &

Regulatory,

Pharmaco-

vigilance and

Quality

Assurance

services for

drug & device

companies.

Est. 2014

Life Sciences Applications & Services

Symphony EDC is an eCRF application with an intuitive workflow,designed by a clinical trial investigator and developed by ARITHMOS

Organizations can work independently to manage

studies «from A to Z» with minimum training

required

Global library: save and reuse eCRF pages to

accelerate timelines

Document management: secured area to share

documentation within an organization and among

study users

Software as a Service: hosted in ARITHMOS’

certified data center

No installation need: just your laptop and internet

browser

www.symphony-edc.com

Oracle Health Sciences Applications

We are Oracle Gold Partner and BusinessProcessing Services (BPS) provider for licensing.

We provide the following as a SaaS solution orimplemented on-site:

Oracle Clinical RDC

Integrated Clinical Data Management (CDM)and Remote Data Capture (RDC) solution tosupport clinical study data collection andreporting

Oracle Argus Safety:

fully integrated platform of end-to-endpharmacovigilance solutions to ensureregulatory compliance from clinicaldevelopment to post-marketing surveillance.

Clinical Data Visualization and Analysis

With SAS® Visual Analytics (providedas SaaS) we

Connect to any source data and create customized /user profiledreports with SAS programs run by ARITHMOS

With SAS® Visual Analytics (providedas SaaS) customers can:

Access data from anywhere to download reports

Integrate with smart devices(smartphones, tablets, etc)

Partner

eLearning

Life Sciences Learning solution is customizablefor any training objectives and meets GxPtraining requirements.

SaaS Application

Practice sections and questionnaires withfinal exam and certification

Sponsor/Client can monitor training progressof users and adjust accordingly

ARITHMOS has eLearning applications in-house for Oracle Clinical RDC and SymphonyEDC

HelpDesk Service ARITHMOS offers a 3 tier HelpDesk serviceto support application users.

Log, track and report incoming requestsvia webtool

Activation in any country, multi-language available

Toll free numbers available

Available 24/7

Reporting on type and frequency of tickets

On-site support if needed

Solutions for Safety and PharmacoVigilance

Safety & Pharmacovigilance

SAFETY SYSTEM AND LICENSING

As an Oracle Gold Partner, we offerOracle Argus Safety Version 8, a market leader solution ideal for managing global workflow while providing case reports and instant safety data reports and analysis.

As an Oracle BPS provider, we provide the licensing on a fixed term service basis.

SAFETY CASE MIGRATION

ARITHMOS offers a validated data migration package for companies usinglegacy PhV systems to move to Oracle Argus Safety

Migration includes regulatory information as an audit trail

Pharmacovigilance reports and signal detection

Line listings for ADRS presentation

Summary tables for period and cumulative

Summary tables to be used for the detection of signals of disproportionate reporting based on different statistical methods (PRR, ROR, Bayesian, etc...)

Reports for Compliance Monitoring for cases submitted to the authorities

Reports can be provided with SAS Visual Analytics

We can support the analysis of data stored in Safety Databases in order to

create reports from PhV systems to meet new regulations and/or satisfy

your analytical needs.

Examples are:

Enterprise Resource Planning

ArithmosCentrum is the only ERP software solution (Enterprise Resource Planning) that can

manage the information flow between Sales, Project Management, Finance and Resourcing

for any project-oriented service provider.

With ArithmosCentrum companies can:

produce budget proposals faster

efficiently manage project plans and resources

stay on budget and invoice customers

Manage documentation and reporting

www.arithmoscentrum.com

ArithmosCentrum is provided either as Software as a Service (SaaS) or installed at customer

premises

Hosting & Maintenance

Applications are hosted in our certified Data Center

Logical and physical security measures in place

Redundancy applied to Servers and components

100% IBMTM systems with fiber channel technology

VmWare infrastructure for virtualization

Redundant backup strategy with off-site secure storage

Disaster recovery site in Milan (160 km from our data center)

IT Quality & Compliance Services

Strategic IT Consulting

Maintenance SupportRange of tasks to keep the compliance with

regulatory and industry standards

Periodic Review of Information Systems

Change Control Management

Internal Audits

Regulatory Inspection support

Continuous training

ISO 27001 consultancy and support for certification

Strategic ConsultingSupport on an as-needed basis for:

Business Process Analysis & Optimization

21 CFR part 11/GxP Risk Assessment

Validation Assessment Plans

Inspection readiness and support

Training on IT compliance

IT QMS development: policies and work instructions

IT Privacy/Security Assessment