Archive for the NEWS Category

Arithmos Announces Partnership Agreement with E-project

Arithmos E-project press release

Arithmos partners with E-project

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 pharmacovigilanceData 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?

Breaking Down The Silos: First Step Towards Fruitful Collaboration

Breaking Down the Silos Regulatory Day

Breaking Down the Silos Regulatory Day

Breaking Down The Silos: First Step Towards Fruitful Collaboration

On the 10th of October the top industry professionals gathered in Madrid, Spain, for Regulatory Day, an immersive workshop organized by Arithmos in collaboration with its partners Oracle Health Sciences and Asphalion.

The event, entitled “Breaking Down The Silos: Product Development Journey through Post-Marketing: EMA vs FDA” brought together the best regulatory, QA, clinical, and pharmacovigilance specialists to discuss how they can collaborate to make the product development journey through post-marketing as efficient as possible both in EMA and FDA regulatory environments.

The Regulatory Day agenda was divided into three sessions, each of them dedicated to a different aspect of product development:

Session #1 Comparison of EMA and FDA Regulatory Landscape in Clinical Trials

  • Introduction to FDA and EU Regulatory Activities for Drug Development and Clinical Trials – Lidia Canovas (Asphalion) and Bruce Thompson (Reguliance);
  • Integrated Summaries: Strategies for Meeting Regulatory Challenges Faced by Sponsors – Marta Zanus (CROS NT);
  • Pre-Marketing Safety Reporting & Signal Detection – Una Kessi (Oracle Health Sciences);

Session #2 Post-Market Regulatory

  • Comparison of US vs EU Regulations, Procedures, Requirements, Practical Examples and Submission Format – Lidia Canovas (Asphalion) and Bruce Thompson (Reguliance);
  • Surveillance and Safety Obligations after Approval – Una Kessi (Oracle Health Sciences);
  • Post-authorisation Studies in the EU: PASS and PAES – Stefania De Santis (seQure);

Session #3 Impact of Technology on Regulatory and Vice Versa

  • The (R)evolution of Technology in the Pharmaceutical Sector – Marcos Fernàndez Gómez (Asphalion);
  • Digital Transformation in Clinical Trials: eClinical Selection and the Regulatory Impact – Silvia Gabanti (Arithmos);
  • How AI and Cloud are Impacting Multivigilance – Michael Braun-Boghos (Oracle Health Sciences);
Breaking down the silos - Regulatory Day

Silvia Gabanti, Arithmos Managing Director, at Regulatory Day

Roundtable discussions

The final part of Regulatory Day engaged the event guests in the roundtable discussions on where the market is moving and invited them to share their own experience in breaking down the silos between departments in their companies.

  • Roundtable #1: Regulatory Challenges in the Industry: EU vs FDA, Brexit, and IDMP
  • Roundtable #2: Breaking Down the Silos between Regulatory Affairs, Safety, and Clinical R&D

Breaking Down the Silos: Complexities and Benefits

The information flow between various departments involved in medicinal product development is not always straightforward, especially when it comes to large companies. Due to the structural obstacles and lack of time caused by pressing deadlines regulatory, clinical, and safety professionals might not fully comprehend the work done by other departments.

Collaboration and continuous information exchange between different professionals that work either in EMA or FDA environment favour the acceleration of product development and increase efficiency. Regulatory Day gave participants a sneak peek into the work of their colleagues and challenges they face, inviting them to explore new ways of collaboration.

Interested in other Arithmos events?

Arithmos Announces Reseller Agreement with Agatha

Agatha Reseller Agreement

Arithmos Announces Reseller Agreement with Agatha

Verona, Italy, September 30th, 2019 – Arithmos, an Information Technology company specialized in technology solutions for the Life Sciences sector, announced that it has signed a reselling partnership agreement with Agatha, a global leading provider of Quality and Content Management cloud solutions.

“Arithmos aims at supporting Life Sciences companies on their road towards Digital Transformation and process optimization. Inclusion of Agatha into our portfolio allows us to cover the document management process, one of the key needs of Life Sciences companies”, said Arithmos Managing Director Silvia Gabanti. “We have chosen to partner with Agatha team due to its personalized approach to each customer and flexible product which Arithmos shares.”

“This partnership allows us to strengthen our position in Italy, offering professional services and post go-live support in Italian.” said Guillaume Gerard, Chief Operating Officer at Agatha. “Arithmos Life Science practice coupled with Agatha top-notched cloud product will help clients in Italy to easily ensure their compliance and streamline their document management and quality processes.”

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

Agatha, Inc. is a leading strategic software solutions provider to the health care and life sciences industry. Agatha is dedicated to helping the world’s Hospitals, biotechnology, pharmaceutical, contract research organizations and medical device firms optimize the management of their Quality, Regulatory and Clinical documentation and processes.

PM Holding Appoints Angela Weston as Chief Commercial Officer

Angela Weston Chief Commercial Officer

PM Holding Appoints Angela Weston as Chief Commercial Officer

Angela Weston Chief Commercial Officer Verona, Italy (11 September 2019) – PM Holding, a group of diverse service providers in the life sciences industry, announces the appointment of Angela Weston as Chief Commercial Officer to manage business development operations across the entire group.

PM Holding consists of specialized service providers in the drug and device development sector including:

  • CROS NT (global, expert biometrics CRO);
  • Arithmos (technology solution provider and system integrator);
  • seQure Life Sciences (niche provider of vigilance, quality assurance and regulatory services).

Angela brings a wealth of experience in business development, marketing and product management roles at a global level for multinational companies in the pharmaceutical, medical device and CRO environments. She started her career in Nursing moving into sales with B.Braun and Boston Scientific, she later moved into the CRO sector with Premier Research Group, Aptiv Solutions (ICON plc) and Inventiv Health (Syneos Health). Angela has an impressive track record of implementing strategies to support global sales, marketing and proposal management with a thorough understanding of our industry and client needs.

The decision to hire a CCO comes at time when the PM Holding group of companies are expanding globally and offering more comprehensive services to the market especially in the area of digital health.

Paolo Morelli, CEO and Owner of PM Holding, said, “we are at a crucial, yet exciting, phase in PM Holding where we are developing new solutions to meet market demands in data science, digital health and overall oversight and quality in clinical trials. It’s a collaborative effort, and I am confident that Angela’s experience and industry knowledge will help us identify our key markets, positioning and message. Her success in implementing successful business development and marketing infrastructure and strategies to enable company growth speaks for itself”.

Angela commented, “for the past several years I have supported companies to develop value generation strategies, and therefore I see PM Holding as a great opportunity and fit for me. The companies under the PMH brand have huge potential both individually and collectively to offer impeccable quality services and innovative solutions to our clients in the global marketplace and I am excited to be part of this growth phase”.

Angela is based in Europe.

PM Holding Announces Joint Regulatory Day Event in Partnership with Oracle and Asphalion

Regulatory Day 2019

Regulatory Day 2019

PM Holding Announces Joint Regulatory Day Event in Partnership with Oracle and Asphalion

Event titled “Breaking Down The Silos: Product Development Journey through Post-Marketing: EMA vs FDA” will take place in Madrid on the 10th October

The PM Holding group of companies including CROS NT, Arithmos, and seQure are excited to announce a Regulatory Day workshop, a unique event in collaboration with Oracle and Asphalion that focuses on the product development journey through post-marketing, and compares the FDA and EMA regulatory landscapes. The workshop aims to not only provide expert sessions on pre- and post-market regulatory topics, but also engage stakeholders, KOLs and industry professionals in the discussion on where the market is moving.

Organizers

Who is hosting this event? A group of international companies specialized in life sciences, healthcare and clinical research with solid experience in the regulatory field and direct contact with European and American regulatory authorities.

    • PM Holding is a group of companies providing an end-to-end service of added value to clinical research through:
      • CROS NT: biometrics specialized CRO
      • seQure: Safety, QA and Regulatory experts;
      • Arithmos, innovative technology and solutions;
  • Oracle is the #1 provider of business software, with a broad portfolio of solutions for companies of all sizes. It boasts 430,000 customers in 175 countries.
  • Asphalion is an International Scientific and Regulatory Affairs consultancy, with offices in Barcelona, Madrid, Amsterdam, and Munich. It provides worldwide support, offering services for Drug Development and Regulatory Affairs to Pharma, Biotech and Medical Devices companies.

Agenda

The focus of Regulatory Day is “Breaking Down The Silos: Product Development Journey through Post-Marketing: EMA vs FDA” and the speakers will guide the participants through the labyrinth of European and American regulations, procedures, requirements, and submission format.

The event agenda features the following topics:

  • Integrated summaries;
  • Pre- and post-market safety;
  • Digital Transformation in Clinical Trials.

The detailed agenda can be downloaded here.

Logistics

The immersive event will take place on the 10th of October at the Oracle office in Madrid, capital of Spain and a centrally located city strategically situated near important pharmaceutical and biotech hubs.

The event participants can reach the venue from the center of the city by metro or by taxi.

Registration

The participation in the event is free of charge and can be done following this link.

Every pass includes:

  • Participation in scientific sessions;
  • Participation in the roundtable discussionsr;
  • Coffee breaks and lunch;
  • Access to the presentation material post-event.

Questions?

In case of questions, get in touch with us via email at info@arithmostech.com.

Interested in more Arithmos updates?

PM Holding Companies Join Healthcare Businesswomen’s Association

HBA Healthcare Businesswoman’s Association

HBA - Healthcare Businesswoman’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?

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

ACDM: New Era of Data Management

ACDM Data Management

ACDM Data Management

ACDM: New Era of Data Management

The annual event of the Association for Clinical Data Management (ACDM) took place last month in Amsterdam. ACDM represents professionals working in clinical data management: from data collection and database builds to technology solutions for data capture. For 30 years, ACDM has been at the forefront of change in all aspects of data management.

This year, just as last year, Arithmos had the pleasure to participate in ACDM as an exhibitor and was present through the whole event that lasted two days. What did we take away from this insightful event?

About ACDM Annual Meeting 2019

Staying updated on industry developments is a priority for us. Arithmos is very active in data management, as it provides consultancy to Life Sciences companies and has developed its own EDC system Symphony. We recognize that with emerging new technologies and regulatory changes like GDPR, it is particularly important to stay informed and compliant.

Attending industry events like ACDM is a great occasion to catch up with the colleagues and discuss just how this field is evolving.

Here are just a couple of facts about ACDM:

  • Total amount of participating companies: 90;
  • Number of exhibitors: 15;
  • Number of sponsors: 5;
  • Number of presenters: 21;
  • Growth of the audience since 2018: +15%.

The outstanding fact about ACDM 2019 was its focus on digital transformation. The agenda featured many topics related to this fascinating, yet still developing trend of digital transformation, such as mobile sensors in clinical trials and artificial intelligence. It marks a new era in data management – how are new technologies impacting the field of data management, transforming the ways we looked at it before and demanding the reorganization of existing processes.

We all remember years ago when the great debate was paper or electronic CRF, pointing out the pros and cons of each. The field has now reached a new great debate, and that is how to integrate disruptive technologies such as wearables and mobile sensors into the existing data management collection and analysis processes with which we are already familiar.

We were particularly eager to learn how companies are managing vendor oversight when it comes to data management, which disruptive technologies companies are applying to data collection and how GDPR has had an impact on data management processes and EDC systems.

ACDM Data Management

ACDM Annual Award

This year Arithmos, together with its sister company CROS NT, was honored to be shortlisted as a finalist for an ACDM excellence award. The Annual Award was established in order to highlight the achievements in data management among ACDM members.

Arithmos together with CROS NT presented its observational study project being carried out with a large pharma player. It involves hemophiliac patients and redefines the way we look at data collection and management in the era of digital transformation.

Data is being collected via ePRO as well as a FitBit wearable device with the aim of analyzing the impact of physical activity on these hemophiliac patients for at least 10 hours per day for the duration of the study. Using an innovative eClinical platform both the ePRO and FitBit data are automatically transferred into the eCRF (Symphony EDC – a product of Arithmos) making it easy for the Investigator to analyze the data.

Impact and Benefits:

  • The project is successfully applying “disruptive technologies” (IoT) to implement more efficient data collection and management processes;
  • The inclusion of wearables creates better patient engagement and retention in providing a non-invasive and interactive collection tool;
  • Guaranteed data privacy and security as Arithmos is an ISO 27001:2014 certified company.

Do you want to know more about the digital solution we presented at ACDM 2019? Learn more about Symphony EDC,  a proprietary Software as a Service Electronic Data Capture solution with a GDPR compliant database, which was originally designed by an investigator and further developed by Arithmos.

Request your free non-binding demo by sending us a request through the website

Want to know more about the events we attend/organize?

Arithmos appoints Silvia Gabanti as new Managing Director

Silvia Gabanti Managing Director

Arithmos appoints Silvia Gabanti as new Managing Director

Verona, Italy (3/04/19)

Silvia Gabanti Managing DirectorArithmos, an Information Technology company specialized in technology solutions for the Life Sciences sector, has named Silvia Gabanti as its new Managing Director. Silvia was promoted from her role of Service Delivery Manager that she held for the last two years.

Silvia Gabanti joined Arithmos as IT Manager in 2010 during the company’s startup and growth phase. As Life Science Applications Manager and Project Manager, she led key research and development projects such as Symphony EDC and Argus Blueprint.

Silvia began her career in the CRO environment where she developed experience in applications for pharmacovigilance and clinical trials. On her career record, she also has experience as an Oracle application analyst particularly with pharmacovigilance and clinical systems like Oracle Clinical. With an impressive 15-year track record in the industry, Silvia exhibits developed skills in managing operations with both in-house and remote teams, providing clear guidance and leadership.

Building on her Service Delivery and clinical IT management experience, Silvia will join forces with the Arithmos team to scale the business on a European level and bring Arithmos to the forefront of technology expansion in Life Sciences.

Paolo Morelli, CEO of Arithmos, said: “We are excited to welcome Silvia Gabanti in the position of Managing Director. Her knowledge of the market and expertise in innovation and across the product field are of undeniable value for the future of Arithmos. In addition to her industry knowledge, she knows Arithmos as a company and has seen it grow and certainly knows its potential”.

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

Interested in more Arithmos updates?

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

Pharmaco- and Medical Device Vigilance Survey

Pharmaco- and Medical Device Vigilance Survey

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.

Most interesting Pharmaco- and Medical Device trend

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.

Most important features of safety system solutionMost important features of safety system solution

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:

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

ISO 27001 Re-certification

ISO 27001 re-certificationArithmos 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.

 

Page 1 of 3123

Follow us on Twitter

RESOURCES

NEWS