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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

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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.

 

[EVENT] Arithmos @PhV Day | Rome | 7 November

PhV Day 2018 Rome

PhV Day 2018 Rome

Arithmos @PhV Day | Rome | 7 November

As technological experts in Pharmacovigilance and Drug Safety, we market leaders in understanding the global challenges of pharmacovigilance operations and adapting them to local market needs and regulations. This means, of course, attending main industry events, such as PhV Day. Arithmos is excited to confirm its presence at PhV Day Italian edition on the 7th of November in Rome!

This event brings together safety experts from the pharmaceutical and healthcare industries, so we are looking forward to meeting professionals from pharma and medical devices companies, biotech, Regulatory Authorities, and academic research centers.

This year is a year of changes with Brexit, GDPR and technological advances that are continuously revolutionizing the pharmacovigilance field and the choice of a safety system and its implementation. The PhV Day will embrace these hot topics with the following agenda:

  • Brexit;
  • Reduced functionality of RNF;
  • EU General Data Protection Regulation (GDPR);
  • Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use;
  • Evolution in the digital era;
  • Global quality system aimed at patient security;
  • Product quality and data integrity.

Technology and Pharmacovigilance

Arithmos at PhV Day will showcase its key pharmacovigilance solution – Argus Blueprint. Argus Blueprint is a pre-configured and fully validated solution for fast deployment of Oracle Argus Safety that allows companies to implement or change Pharmacovigilance systems in the most accurate, timely and cost-effective manner. An updated Pharmacovigilance system is extremely important now in light of the GDPR and patient security requirements that are aimed at ensuring certain level of security of data management. It is also part of a bigger process of digital transformation happening in Pharmacogivilance nowadays.

Are you running a discontinued or outdated Pharmacovigilance system? Make sure you stop by at our stand at PhV Day to discuss how you can enhance your security and migrate to a safer system because companies in Life Sciences risk security breaches and non-compliance issues if they do not migrate to more up-to-date Pharmacovigilance systems.

Do you want to meet us and talk about choosing the right pharmacovigilance system and safety of your data? Our Business Development Manager Anna Bottura will be representing Arithmos at PhV Day in Rome, so make sure you book an appointment with her by sending us a meeting request.

See you in Rome!

 

 

 

 

[Infographics] Five key trends in AI-Healthcare

AI in healthcare

Five key trends in AI-Healthcare

Healthcare is undergoing digital transformation, and now there are no doubts about it: technology has become its integral part, conquering more and more aspects of patient interaction, R&D and clinical trials. The most frequent word that you will now hear when it comes to healthcare digitalization is “AI” or “Artificial Intelligence”.

AI is said to be a game changer that could allow for reductions in healthcare costs as well as workload reduction for physicians which can result in clinical trial optimization and better early diagnostics. The growth predictions are staggering: McKinsey estimates AI to have the potential to create between $3.5T and $5.8T in value annually across nine business functions in 19 industries.*

We decided to look at what could be the key AI trends in healthcare that have the potential to revolutionize healthcare:

Arithmos always strives to be at the forefront of digital transformation in life sciences by applying technologies that satisfy the customer’s needs while achieving the best results in R&D, Clinical Research, Pharmacovigilance and Medical Project Management.

Are you planning to incorporate digital transformation in your company’s strategy? We would be glad to help you! Send us a request by filling in the contact form and let’s discuss how to introduce digital transformation in your life sciences strategy!

*Retrieved from Forbes “Sizing The Market Value Of Artificial Intelligence” on 01.10.2018.

Summary: conference “Artificial Intelligence and Clinical Research” (Milan) | What is the industry saying?

Artificial Intelligence in Clinical trials Milan

Summary: conference “Artificial Intelligence and Clinical Research” (Milan) | What is the industry saying?

Artificial Intelligence (AI) is a hot topic in the world of clinical trials, with researchers, academics and industry experts examining how it can “change the rules of the game”. Arithmos strives to be at the forefront of digital transformation in life sciences, so on the 18th of September we were present at the conference “Artificial Intelligence and Clinical Research” (Intelligenza artificiale e ricerca clinica) to get the latest updates from the industry. It took place at Politecnico di Milano, the largest technical university in Italy and looked at analyzing the possibility of simplifying the clinical research process with Artificial Intelligence.

The event featured such speakers as:

  • Massimo Beccaria, Managing Director Alfa Technologies International;
  • Giuseppe Recchia, Vice President Medical Scientific, GSK;
  • Matteo Matteucci, Associate Professor of Politecnico di Milano (Robotics, Cognitive Robotics, and Machine Learning);
  • Roberto Fantino, Presidente NAT Style;
  • Enrico G. Caiani: Associate Professor of Politecnico di Milano, Chairman WG e-Cardiology European Society of Cardiology, Docente eHealth and Bioengineering;
  • Giorgio Manfredi, CEO Rumbletumbleweed, CEO Occambee, Founder Forever Identity Inc., Advisor ISMC;
  • Maurizio Viviani, CEO Strong Artificial Intelligence;
  • Ettore Murciano, VP Channel Sales and Alliances, Loop AI Labs Inc;
  • Eugenio Santoro, Responsabile del laboratorio di informatica medica, Istituto di Ricerche Farmacologiche Mario Negri – IRCCS;
  • Sergio Scaccabarozzi, Head of Country Clinical Operations-Italy, Roche.

All the speeches represented very interesting insights from various points of view – research center, private company or university. What were some key points we took home? We first look at how the industry is being setup to look for AI solutions:

Giuseppe Recchia, Vice President Medical Scientific, GSK:

  • The future of clinical research will be defined between 2018 and 2020;
  • The whole revolution in clinical trials is about searching for a solution for faster development of the cure;
  • Everything in clinical trials revolves around patients and gives birth to such notions as patient centricity and patient engagement. With time how the patient views himself has also changed:
    • Patient now does his own research, using his/her health data;
    • Patients now have their own input, for example, they are involved in medicine R&D;
    • Patient-expert is a new concept, formed only recently. Such patients have the experience of the illness and expertise. For example, they could have had training or understanding of the research dynamics and the regulatory basis.
  • The aim of modernizing Clinical Trials is getting us to the cure faster. Why is the process so lengthy now? There are several reasons: low enrollment rates, retention problems, adherence (patients do not take meds and says he/she does), quality, costs.
  • What are the steps in clinical trial modernization?
    • First step is developing patient centricity:
    • Second step is connecting to the patient. It is extremely important now, as siteless clinical trials are being developed because patient spend more time at home than at the research site.
    • Third step is modernization in the field of wearables;
    • Fourth step is taming big data;
    • Fifth and last step is applying AI in clinical trials;
  • Right now no pharma company applies these technologies at 100%, however, big steps are already being taken in this direction.

Enrico G. Caiani: Associate Professor of Politecnico di Milano, Chairman WG e-Cardiology European Society of Cardiology, Docente eHealth and Bioengineering:

  • Why does health care need AI? There are several main reasons:
    • For the quantity of data and its complexity: at the moment each person generated 1100 TRB during his/her lifetime;
    • For the sake of patient safety;
    • For achieving higher efficiency in terms of time;
  • AI is capable of changing the future of medicines in all its aspects from administrative to clinical;
  • The demand for AI in the scientific society grows every year: in 2013 at ESC Congress there were only 3 AI presentations and in 2018 – already 69;
  • What prevents AI from being adopted right away in clinical practice?
    • Pathology is always complex, so here having a big dataset is of ultimate importance. This enlarges costs and times for the medical data production. Moreover, since healthcare datasets are not usually shared, the possibility of using joint datasets is not available.
    • The clinical evidence is not sufficient since now there is a limited amount of evidence in research literature that can prove that AI is a superior technique.
    • This, in turn, triggers another barrier for AI adoption: lack of transparency on training, lack of information on timing and content of updates, lack of reports on performance and eventual fails;
    • Last, but not the least: the definition of ethical principles in AI is missing. In order to proceed with AI adoption, it should be clarified how AI can influence doctor-patient relations and decide who is responsible for errors caused by AI.

Eugenio Santoro, Responsabile del laboratorio di informatica medica, Istituto di Ricerche Farmacologiche Mario Negri – IRCCS:

  • What should be done in order to use AI in clinical research?
    • A structured approach should be implemented, as 80% of the data generated every day is not structured. Right now a huge amount of data is produced due to the use of smartphones, IoT and wearables, which has no formal system. The situation got escalated in the last 2 years – during which 90% of the world data was generated.
  • What is the potential of AI in healthcare?
    • Prevention and predictive models;
    • Early diagnosis;
    • Machine learning and chatbot;
    • Analyses of disease cause-effect, also called epidemiology 2.0. AI is employed here for finding possible logical connections between potential cause and effect;
    • Drug Discovery and clinical trials;
  • How can AI improve clinical research in particular:
    • Aggregation and synthesis of information: AI allows intuitive searches in the world biomedical research data including biomedical databases;
    • Recruiting for clinical trials: AI can analyze medical records and other unstructured documents to find the appropriate patients for clinical trials and can accelerate recruitment to complete the clinical trial faster.
    • Understanding the mechanism of disease: AI can analyzes databases, connecting published literature, experimental data, and clinical data and allows researchers to get insight into how the disease mechanism operates;
    • Repurposing existing drugs: AI can synthesize knowledge from multiple biomedical sources and find new indications for existing drugs;
    • Generate novel drug candidates: AI can generate novel drug candidates faster;
    • Optimize clinical trials: AI can analyze data of participants and reduce the dropout rates through personalized communication;
    • Publish data: AI can write a draft of a scientific manuscript based on provided data;
    • Sentiment analysis: AI can assist in the pharmacovigilance process by monitoring the adverse events and help with the study of public health, such as infection and drug abuse.

Workshop: Industry 4.0 and Life Sciences

Workshop Industry 4.0

Industry 4.0 Life Sciences

Workshop: Industry 4.0 and Life Sciences

This June, experts in the Life Sciences industry gathered in Milan to participate in a workshop on “Industry 4.0: The New Challenges for Project Planning and Oversight in the Life Sciences Industry”. The workshop was a result of joint efforts between our Arithmos team and LS Academy and was organized in order to peek into changes triggered by Industry 4.0.

Industry 4.0 is a recent concept that encompasses all the processes of automatizations and emerging cyber-physical systems in different industries. Life Science is among the areas most affected by these changes due to its willingness to adopt new technologies and its responsiveness to new trends. During our workshop, we covered different aspects of the Life Sciences industry that are affected by Industry 4.0.

Workshop agenda

We have invited a number of Key Opinion Leaders from the Pharma and Life Sciences fields to share their experience and ideas on Industry 4.0. Here are the topics they have covered during the workshop:

  • IoT and Big Data: advantages and opportunities of eHealth technologies in Life Sciences Sector.
  • New challenges for Human Resources in Industry 4.0: Management time planning research results and their structure.
  • Sponsor Oversight Management: Effective use of third party technology.
    • Speaker: Heike Schoen, Managing Director and Co-Founder at LUMIS International GmbH;
  • New model of Industry 4.0: Altea UP. Instruments and technologie for the pharma process governance.
  • Implementation strategy of ClinOps system: challenges and choices.
    • Speaker: Daniele Segagni, Group ICT Global Business Process and Application Specialist, Chiesi Group
  • How new technologies are changing patient relations: from the SEO era to IA and chatbot.
    • Speaker: Matteo Nicolosi, Web Content Developer at Istituto Clinico Humanitas;
  • How intelligent automation is reshaping the workforce landscape.
    • Speaker: Andrea Melison, Senior Manager Business Service at KPMG Italy.

Best quotes of the workshop

  • “Blending IoT, Big Data and AI in clinical trials processes can greatly improve the competitiveness of CROs and Pharma/Medical Companies, while at the same time lowering the costs of clinical research and facilitation the invention and validation of new medical products and services that will revolutionize healthcare in the years to come.” – Paolo Morelli
  • “Digital revolution has positive effect if it helps employers to compress time needed for standardized activities and relocate it to work activities that require non-standard approach.” – Roberto Bugatti
  • “Company should set adequate extended and shared IT Governance structure, which ensures that the company data is managed correctly.” – Pierluigi De Rosa
  • “Real-World Evidence could be used from R&D departments to support regulatory submissions for additional drug indications and to inform new drug development.” – Daniele Segagni”
  • “Robotic Process Automation and digital labor can be scaled much more quickly and cost effectively than traditional IT implementations.” – Andrea Melison

Want to get expert content from the workshop? Send us a request via our online contact form!

[Event] Arithmos @Swiss Biotech Day 2018  |  Basel |  3 May

Arithmos Swiss Biotech Day Basel Switzerland 3May
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