Arithmos Announces Partnership Agreement with E-project

Verona, Italy, November 11th, 2019 – Arithmos, a provider of innovative IT solutions with a specific focus on the Life Sciences value chain, announced that it has signed a partnership agreement with E-project, a consulting and system integration company.

The first result of this collaboration is already underway. The two companies have brought a unique technology solution for pharmacovigilance – Data Analytics and Reporting tool based on Qlik data analytics platform to the market. The tool allows Life Sciences companies to easily ensure reporting compliance as well as benefit from the advanced analysis of their safety data.

“Arithmos’ mission is to accompany Life Sciences companies on the Digital Transformation path. We work continuously on enriching our expertise and partnership network in order to give 360-degree support to our clients”, said Arithmos Managing Director Silvia Gabanti. “E-project is a company with advanced technical expertise which is complimentary to the one that Arithmos has. We are lucky to find a partner that shares our vision, our values and our goals.”

“Collaboration with Arithmos is a great opportunity for us to develop and bring new solutions to the market. We implement successful Digital Transformation strategies since 2001. We are happy that Arithmos will accompany us in this journey”, adds President of E-project, Massimo Businaro.

Arithmos is part of PM Holding, a group of companies operating in the Life Sciences sector. PM Holding provides a complete platform of products and services for end-to-end drug and device development.

E-project is a consulting and system integration company founded in 2001 by professionals from the world of consulting. In its work, E-project addresses issues related to the re-engineering of business processes of customers.

Interested in more Arithmos news?

• Arithmos Announces Reseller Agreement with Agatha;
• PM Holding Appoints Angela Weston as Chief Commercial Officer;
• PM Holding Companies Join Healthcare Businesswomen’s Association;

PM Holding Companies Join Healthcare Businesswomen’s Association

CROS NT, Arithmos, and seQure Life Sciences have become a corporate partner of the women’s association

Verona, Italy (20 June 2019) – PM Holding, a life sciences holding company comprised of CROS NT, Arithmos, and seQure Life Sciences, announced a corporate sponsorship for all three companies with Healthcare Businesswomen’s Association (HBA).

HBA is a global non-profit organization comprised of individuals and organizations from across the healthcare industry. With CROS NT as a corporate sponsor, all three companies are teaming up to support gender parity in the healthcare industry. HBA counts over 10,000 global healthcare professionals throughout the U.S., Europe and Canada.

The PM Holding companies already boast a female empowered workplace with approximately two-thirds of its workforce across the globe being female. Arithmos, who specializes in Information Technology for the Life Sciences sector, has already secured a 50 percent gender balance in the company whereas the average for women in tech around EU countries varies between 16% and 26%.[1]

The HBA application process was led by Mary Wieder, Director of Marketing and Corporate Social Responsibility for PM Holding, who commented: “PM Holding is honored to join like-minded companies and leading players in the industry in the task of fostering gender parity in leadership positions. Our team is committed to advancing the impact of great professionals in Life Sciences regardless of their gender as well as creating an environment of continuous networking and training”.

Paolo Morelli, CEO and Owner of PM Holding, says: “our companies are proud to be at the forefront of female leadership in various fields of life sciences. Women hold prestigious and managerial roles in all areas including clinical trials, data science, and technology as well as high-level consultancy and business analysis. All of our companies lead by example, showing how diversity and equality generate great results”.

As a company with a high percentage of female professionals, which includes the top manager, Arithmos is excited to further the advancement of women in the business of healthcare.

 Interested in more Arithmos updates?

• Press release: Arithmos appoints Silvia Gabanti as new Managing Director;
• Press release: Arithmos Successfully Completes ISO/IEC 27001:2013 Re-Certification;

[1] Honeypot, 2018 Women in Tech Index. Retrieved online.

Pharmaco- and Medical Device Vigilance Survey: what is the industry focused on?

New EudraVigilance, the EU Medical Device Regulation (MDR), Brexit, AI, and automation technologies – these are just a few topics that are actively being discussed for the last year. At our recent stakeholder update meeting organized with Oracle in Milan, we looked at some of these trends closely: experts from Arithmos, its sister company seQure and Oracle presented regulatory changes in Medical Device vigilance, new technologies in signal detection and change of demand in pharmacovigilance outsourcing.

We asked participants of the event, from pharmacovigilance to IT professionals of high seniority, to share their idea of the biggest challenges in pharmacovigilance, the most crucial trends and main decision factors for choosing the right vendor. This is what we learned.

What is the biggest challenge in pharmacovigilance in your opinion?

Most of the participants find implementing efficient safety system and database the biggest challenge. The second main challenge is ensuring quality in pharmacovigilance, which is followed by difficulties with the integration of the new technologies and coping with the regulatory landscape. The least widespread challenge is setting up an efficient signal system.

What is the most interesting Pharmaco- and Medical Device trend that you are following?

On the trends question the respondents are divided into three groups. The first and biggest group has chosen AI and Cloud technology as the most intriguing trend in the industry. However, during our stakeholder meeting revealed that most people are still unsure of the benefits of AI and how to manage it. The second place is divided between Medical Device Regulation and Automation technology.

Which factors are the most important for you when it comes to a safety system solution?

Although the importance of different factors varies among the participants, the security and privacy factor was unanimously recognized as “very important”. Among other important factors are functionality, costs, scalability, and speed of implementation. This is one of the most significant changes we have seen over the past few years: the rise of concerns over data and information security and privacy. This further proves the importance of important security measures such as certifications, an Information Security Management System and a comprehensive GDPR compliance roadmap.

Conclusion

With the pharmaco- and medical device industry evolving at high speed, trends and hot topics in the industry also change very quickly. However, as the survey shows, most of the topics and issues that concern the industry have persisted for years, such as AI in healthcare, MDR, and privacy and security.

The interests and concerns of the industry heavily shape vendor selection and oversight and safety system solution requirements. Solutions that combine efficiency, security and quality are increasingly in demand on the market, yet they are not so easy to find.

Argus Blueprint, a pre-validated and preconfigured version of Oracle Argus Safety, is one of these solutions, as it guarantees highest quality and efficient performance. Backed by an ISO 27001 certified ISMS, it responds to the challenges and demands of the pharmaco- and medical device market.

Want to learn more about Argus Blueprint? Book your free demo through the request form at the bottom of this product page!

Would you like to participate in Arithmos free events dedicated to the most recent trends in pharmaco- and medical device vigilance? Contact us via contact form with “Newsletter” in the message body and receive the invitations to our next stakeholders update meeting!

Other materials to read on this topic:

• Data Protection Day
• Industry 4.0 and Life Sciences

Arithmos Successfully Completes ISO/IEC 27001:2013 Re-Certification

Verona, Italy (19/02/19) 

Arithmos is pleased to announce that, following a thorough audit by a competent authority, it has successfully earned re-certification for the ISO/IEC 27001:2013 standard regarding its Information Security Management System (ISMS).

ISO/IEC 27001:2013  is the best-known international standard for the implementation of an Information Security Management System which includes key processes such as business continuity and disaster recovery. The standard also takes a systematic approach to risk in order to ensure  information security and protection – an area which Arithmos sees as absolutely critical in today’s life sciences landscape.

The re-certification of ISMS is an important step in Arithmos’ internal GDPR compliance roadmap. The EU General Data Protection Regulation, specifically Article 32, requires ongoing confidentiality, integrity and availability of processing systems and services as well as a process for risk mitigation.

Paolo Morelli, CEO of Arithmos, says, “in our experience managing clinical and safety data, we are aware of the importance and necessity of data privacy and data security in the era of digital transformation in healthcare. This is why we have invested heavily not only in an internationally recognized standard such as ISO 27001, but also in detailed internal procedures and a comprehensive roadmap that ensure GDPR compliance and peace of mind for our customers that their data and information are always secure and compliant. Today it’s more than an added-value, it’s a necessity”.

As a “data processor”, Arithmos takes necessary measures to ensure data privacy and security for all of its products and applications. The ISO/IEC 27001:2013 standard applies to Arithmos’ proprietary electronic data capture (EDC) system, Symphony EDC, third party EDC applications, Oracle Argus Blueprint safety system, clinical data reporting and analysis tools as well as its HelpDesk ticketing platform.

ARITHMOS, PART OF PM HOLDING, ANNOUNCES COLLABORATION WITH WINGS FOR LIFE FOR CORPORATE SOCIAL RESPONSIBILITY PROJECT

05 March 2018 (Verona, Italy) –Arithmos, part of the PM Holding, group of companies operating in the life sciences industry, today announced its continued collaboration with Wings for Life as part of its 2018 Corporate Social Responsibility (CSR) project.

The PM Holding group of companies is composed of CROS NT, Arithmos and seQure Life Sciences, and the companies are collaborating on various initiatives to support Wings for Life and its scientific and clinical research. Wings for Life is a non-profit organization supporting cutting-edge international research for spinal cord injuries.

PM Holding collaborated with Wings for Life in 2017 for various fundraising initiatives. Throughout 2018, the group of companies plans to support Wings for Life with various fundraising initiatives including the Wings for Life World Run on 6^th of May.

Paolo Morelli, CEO and Owner of PM Holding, said, “we are extremely pleased to extend our collaboration with Wings for Life again this year. Our team is proud of the work we have done in terms of corporate social responsibility, and we are excited to contribute to this new strategic partnership model taking shape in the clinical research environment in which service providers like ourselves apply our strategic and operational knowledge to organizations conducting research for social good – the new moral code in pharma”.

“Wings for Life is the fortunate recipient of PM Holding’s CSR activities.  In addition, our two organizations are well aligned in the focus on cutting-edge international research.  We look forward to continued collaboration towards our shared goals”, said Jane Hsieh, ATP Executive Director at Wings for Life

About Arithmos

Arithmos is an ISO 9001 and ISO 270001 certified IT company focused on Life Sciences industry. Our solutions support multiple clinical trial processes enhancing efficiency and global alignment:

• Electronic Data Capture: Symphony EDC is an intuitive SaaS EDC solution designed by investigators and developed by Arithmos to allow a quick and autonomous study set up and management, fully in compliance with international standards;
• Clinical Trial Management: SYNClevy is and Extended Project and Portfolio Management system developed to support clinical project managers in their daily activities’ planning and management, increasing collaboration among all company’s departments and enhancing Clinical Trial Oversight, as required by ICH GCP E6(R2);
• Pharmacovigilance: Argus Blueprint is a pre-configured, fully validated pharmacovigilance platform for the fast deployment of Argus Blueprint.

About Wings for Life

Every eight hours someone in the UK sustains a spinal cord injury and most become wheelchair users as a result. Spinal cord injury affects people of all ages and backgrounds and is most commonly caused through road traffic accidents, falls, illness or sports. Spinal cord injury happens in a moment, but the impact lasts a lifetime. After an injury, most people live through months if not years of rehabilitative therapy. There is currently no medical treatment available to repair the injured spinal cord.

Wings for Life fund world class scientific research and clinical trials around the globe aimed at finding a cure for spinal cord injury. Since being founded 170 spinal cord research projects have been funded at the world’s most well-respected institutes and a number of vital breakthroughs have been made.

Wings for Life’s research focuses on how to minimize damage, stimulate repair and restore function after an injury to the spinal cord has been sustained. The developments so far provide strong hope that treatment options are closer than they have ever been. However, intensive research work is needed before a breakthrough in human medicine can be achieved.

When you support Wings for Life, 100% of the money you donate will go to directly to spinal cord injury research as the charity’s founders generously cover all of the administrative costs.

More information on the project Wings for Life:

• Website;
• Facebook;
• Instagram @WingsforLifeOfficial;
• Wings for Life World Run

Read more →