Arithmos LS
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Arithmos is a technology company founded in 2010 that specializes in tailored solutions for life sciences, including GxP applications, IT compliance, and clinical data visualization. It offers proprietary software, ISO-certified services, and comprehensive support in clinical data management and pharmacovigilance, and is an Oracle Gold Partner providing various SaaS solutions. The company also focuses on staff recruitment and eLearning solutions customized for training in the life sciences sector.
Arithmos LS
- 2. Who We Are… Technology company specialized in tailored solutions for life sciences: GxP applications and services, CSV & IT Compliance consultancy, 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)
- 3. 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
- 4. 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
- 5. Life Sciences Applications & Services
- 6. 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
- 7. Oracle Health Sciences Applications We are Oracle Gold Partner and Business Processing Services (BPS) provider for licensing. We provide the following as a SaaS solution or implemented on-site: Oracle Clinical RDC Integrated Clinical Data Management (CDM) and Remote Data Capture (RDC) solution to support clinical study data collection and reporting Oracle Argus Safety: fully integrated platform of end-to-end pharmacovigilance solutions to ensure regulatory compliance from clinical development to post-marketing surveillance.
- 8. Clinical Data Visualization and Analysis With SAS® Visual Analytics (provided as SaaS) we Connect to any source data and create customized /user profiled reports with SAS programs run by ARITHMOS With SAS® Visual Analytics (provided as SaaS) customers can: Access data from anywhere to download reports Integrate with smart devices (smartphones, tablets, etc) Partner
- 9. eLearning Life Sciences Learning solution is customizable for any training objectives and meets GxP training requirements. SaaS Application Practice sections and questionnaires with final exam and certification Sponsor/Client can monitor training progress of users and adjust accordingly ARITHMOS has eLearning applications in- house for Oracle Clinical RDC and Symphony EDC
- 10. HelpDesk Service ARITHMOS offers a 3 tier HelpDesk service to support application users. Log, track and report incoming requests via 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
- 11. Solutions for Safety and PharmacoVigilance
- 12. Safety & Pharmacovigilance SAFETY SYSTEM AND LICENSING As an Oracle Gold Partner, we offer Oracle 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 using legacy PhV systems to move to Oracle Argus Safety Migration includes regulatory information as an audit trail
- 13. 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:
- 15. 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
- 16. 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)
- 17. IT Quality & Compliance Services
- 18. Strategic IT Consulting Maintenance Support Range 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 Consulting Support 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