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Webinar: Digital Transformation in Pharma: Challenges and Enablers

Digital Transformation in Pharma: Challenges and Enablers

Webinar: Digital Transformation in Pharma: Challenges and Enablers

We are excited to invite you to our new webinar titled “Digital Transformation in Pharma: Challenges and Enablers”. In the last 10 years, the international and Italian managerial debate has focused heavily on the issue of corporate digitalisation. For pharma and healthcare professionals, the digital age brings new uncertainties.

Companies face a difficult choice:

  • Evolve with the new era by building a digital organisation
  • Risk becoming less competitive on the market as they fail to embrace the change

In this webinar we will discuss the challenges that pharmaceutical companies face on the road to digital success and how to overcome them.

Click here to learn more about the webinar and register your attendance

Who should attend?

CIOs, Clinical, Pharmacovigilance and R&D professionals looking for harnessing the power of new digital technologies

Date and time:

Wednesday, October the 21st, 2020, 4:00 PM – 5:00 PM CEST

The key learning outcomes will be:

  • What is digital maturity
  • Main challenges in embracing digital transformation in pharma industry
  • Enables of digital transformation

Speaker: Silvia Gabanti, Managing Director of Arithmos

Silvia has an impressive 15-year track record in the industry. She began her career in the CRO environment as pharmacovigilance and clinical research specialist. On her career record, she also has extensive experience with Oracle applications – as analyst she was working with pharmacovigilance and clinical systems like Oracle Clinical. Frequent speaker at the industry events, for the last two years before becoming Managing Director she held the position of Service Delivery Manager.

White Paper: Oracle Argus Release 8.2.2 – What’s New?

Argus 8.2.2 release

White Paper: Oracle Argus Release 8.2.2 – What’s New?

Scroll down to request the white paper “Oracle Argus Release 8.2.2 – What’s New?”

Oracle Argus is a multivigilance solution for processing, analysing, and reporting adverse event cases originating in pre- and post-market drugs, biologics, vaccines, devices, and combination products. A powerful tool, Argus was designed to solve the pharmaceutical industry’s biggest regulatory challenges.

Oracle Argus allows you to manage adverse event cases more accurately and more efficiently whilst ensuring regulatory compliance and helping Life Sciences companies to satisfy their growing needs.

Oracle Argus is currently used worldwide by a wide range of Life Sciences companies such as:

  • Pharmaceutical
  • Biotech
  • CRO (Contract Research Organisation)
  • Medical device manufacturers

Scalable and efficient, Argus enables the continuous evaluation of the benefit-risk profiles of products throughout clinical development and post-marketing surveillance in accordance with Good Clinical Practice and Good Pharmacovigilance Practice. Argus is a reliable solution that offers proven reporting compliance with regulations and standards at the national and international level.

In July 2020, Oracle released a new version 8.2.2 that addressed new important regulatory compliance requirements, functional enhancements and technology platform currency.

In this white paper we will share the details of the Oracle Argus Release 8.2.2 and analyse the benefits for Life Sciences companies of moving from outdated legacy systems to Argus or upgrading their Argus platform to this new release.

Request the white paper “Oracle Argus Release 8.2.2 – What’s New?”

 

Privacy Policy

Consent pursuant to art. 6 Regulation (EU) 2016/679

Upon reading the Information Notice outlined above:

a) The undersigned shall give specific consent to the processing of personal data for marketing purposes (namely direct sale, sending of advertising material, market research and commercial communication).
This consent is provided for marketing carried out by using both traditional systems (such as paper mail, phone call with operator) and automated systems of call or communication without operator, email, telefax, short text messages, MMS, or other automated means of communication. The data subject’s right to oppose the processing of their personal data for the purpose of direct marketing through automated contact methods also covers the traditional ones, with the possibility of exercising this right also partially.
The data subject may express their consent to receiving communications for the abovementioned purposes exclusively through traditional methods of contact.
The data subject’s refusal to give consent will result in the company’s failure to process their data for marketing purposes.

 

b) The undersigned shall give specific consent to the processing of their personal data for profiling activities.

 

c) The undersigned shall give specific consent to the processing of their personal data for communicating data to third parties for marketing purposes.

 

 

How to Power Clinical Trials with Internet of Things

How to Power Clinical Trials with IoT

How to Power Clinical Trials with Internet of Things

On July 16, Arithmos’ CEO Paolo Morelli has joined a complimentary webinar organised by Avenga, global IT and digital transformation company. This exclusive webinar was prepared for Pharmatech, Life Sciences, Pharmaceutical, Drug Discovery & Development and Healthcare companies and focused on how Internet of Things (IoT) transforms clinical trials.

In this blog we share some of the webinar highlights.

Continue reading to learn about how IoT is used to combine disparate data, improve clinical trials through higher patient retention and reduce trial spans.

Avenga (A): How does the introduction of IoT changed your perspective on the industry?

Paolo Morelli (PM): Nowadays a big variety of patient data including data coming from IoT devices and what I call process data (i.e. KPIs of clinical trial processes) is available. This data becomes more and more valuable for the industry and increases the demand for specialised service providers that are able to work with such big data volumes and harness their potential.

A: What are the key items one should focus on when integrating IoT in clinical trial?

PM: I would outline four key elements:

  • Study team that includes a digital manager to support the integration of the technology in the design of the study and study tools
  • Patient association to ensure that patients will have smooth experience with the new technology
  • Senior Data Managers and Statisticians to cope with regulatory challenges related to data collection and stat methodology
  • Privacy expert

A: When it comes to IoT, what is the difference between a CRO role and a pharmatech company role?

PM: CROs support pharmaceutical companies in conducting clinical trials with clinical and data services. However, most of the CROs are only starting to explore the world of IoT and learning how to integrate them in the traditional services.

On the other side, pharmatech companies have already a broad understanding of technological framework. Thus, they are able to support both pharmaceutical companies and CROs integrating new IT solutions in clinical trials.

A: How do sponsors see IoT in clinical trials?

PM: Sponsors see IoT as a big opportunity as they understand the value of the data that can be generated and used to support clinical evidence and safety of their products. This is valid not only for pharmaceutical and medical device companies, but also for organisations that conduct non-profit studies.

However, the tackling of the growing importance of IoT is also challenging, as a lot of industry players still do not possess necessary analytical and technical capacities.

A: Have you had to adjust the compliance framework as well as other SOPs for the IoT related projects that Arithmos has conducted so far?

PM: Not too much, as the processes are independent from the type of source data and its quantity.

A: What are the new skills that young professionals should add to their skillset to be relevant in this labour market?

PM: Analytical skills are becoming increasingly important for both data scientists and clinical researchers, as they will need to understand the massive amount of reports available in every clinical trial.

Digital managers will also become indispensable for the correct selection and integration of IoT tools in clinical trials processes.

A: What is the connection between big data and data science and IoT?

PM: Data scientists have an important role in bringing together the huge massive of data that arrives from IoT devices.

A: How do you think Covid-19 impacted use of IoT in clinical trials?

PM: I think there will be much more focus on decentralised clinical trials that involve IoT devices and further enhancing technology with the buying both from sponsors and patients.

Would you like to learn how Arithmos can support you in innovating your clinical trials? Contact us by clicking here.

Interested in more materials on Digital Transformation?

Arithmos and E-project Launch Kairos, Data Analytics and Reporting Solution for Pharmacovigilance

Kairos, Data Analytics and Reporting solution for Pharmacovigilance

Arithmos and E-project Launch Kairos, Data Analytics and Reporting Solution for Pharmacovigilance

Verona, Italy, May 26th, 2020 – Arithmos, a provider of innovative IT solutions for Life Sciences, together with its partner E-project, a consulting and system integration company, announced the launch of Kairos, innovative Data Analytics and Reporting Solution for Pharmacovigilance.

Kairos gives Life Sciences companies full visibility of their safety data with real-time reports and dashboards, easily ensures regulatory compliance and creates value from the advanced analysis of their safety data.

Kairos, Data Analytics and Reporting solution for PharmacovigilanceBorn as a platform for the pharmacovigilance department, Kairos can also serve as a horizontal solution that fosters collaboration between departments and gives a company a bigger picture of its data. The innovative solution helps Life Sciences companies make faster and more robust decisions based on the data analysis and visualisation, safeguarding patient’s health more efficiently.

The capabilities of Kairos include:

  • Minimised risks as clear data visualisation makes complex pharmacovigilance data easier to grasp and act on
  • Improved decision making, as data can be easily combined, loaded, and visualised
  • Reduced investments in reporting across the business, as the same tool can be adopted by multiple departments

Features:

  • System agnostic – can be connected to any data source
  • Flexible reporting system – creation and fine tuning of any reports
  • Visual – the solution gives clear visual representation of the data in multiple formats

“We have been providing pharmacovigilance technology for 10 years and we know the most common pains of pharmacovigilance teams. Limited reporting capability is one of them and Kairos solves it by offering a whole range of advanced reports and data visualization dashboards”, said Arithmos Managing Director Silvia Gabanti. “We also believe in lean operations and processes, so we wanted to introduce a solution that can be versatile, and be used across the departments, breaking down the silos between them and allowing more collaboration”.

“In E-project, we are committed to applying our expertise in process engineering and data analysis, to help our customers to harness the power of data. Kairos empowers Life Science organisations to make better decisions daily and become truly data-driven”, said Massimo Businaro, president of E-project.

Contact Arithmos now to see the demo

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.

Francesco Danzi
Inside Sales Associate
francesco.danzi@arithmostech.com

Career Insights: Interview with Marco Pastore, Business Analyst & Project Manager

Career Insights: Interview with Marco Pastore, Business Analyst & Project Manager

In this new blog from ‘Career Insights’ series we talk to Marco Pastore, Arithmos’ Business Analyst and Project Manager, to find out more on his background, career path, and his interests outside of work.

Marco Pastore Business Analyst & Project Manager

Have you always been passionate about Life Sciences field?

I developed an interest in this industry few years ago. I hold a degree in Computer Engineering, and people with this background mainly work in the banking or insurance industry. I wanted to work in a very dynamic and fast-growing industry, and the pharmaceutical industry seemed like a perfect option. It was also a great opportunity not only to do my job, but also to help patients achieve better and healthier lives.

What has been your journey to your current role at Arithmos?

After graduation I concentrated on cutting-edge technologies. I worked as a System Integration Specialist in one of the leading international technological service providers. I also worked for an industrial automation company where I had the opportunity to explore the world of the Internet of Things and Industry 4.0.

After that I started my journey in the Life Sciences by joining a company that produced pharmaceutical ingredients. There I was appointed as National Coordinator of Telemetry and explored the world of healthcare by working closely with the hospitals. This was a great way to obtain industry specific knowledge of validation processes and regulations for specialized software. This experience was so handy when I joined Arithmos!

My meeting with Arithmos happened when I decided to look for a job that would give me a possibility to mix business and technology approaches. I came in for the interview and loved the Arithmos spirit! What impressed me the most was the expertise of my potential colleagues and the structural approach to the projects. I knew that in this way we could deliver superior services with clear objectives and deadlines.

How did you identify Project Management as the right career for you?

I was looking for a career path that will allow me not only to perform the operative tasks, but also be engaged in the business side of the project. Project Management allows me to get a 360-degree view of the project, both technical and business, so I have a bigger possibility to influence the outcome of the project, offer new solutions and be innovative. I am loving the innovation part, because my technical background allows me to come up with new ideas for our clients.

Why were you assigned a dual role of Business Analyst and Project Manager?

Ideally, the first step in the collaboration with a client, is understanding their needs and circumstances, and based on these, suggesting a solution. This work is done by a Business Analyst. Once the collaboration starts, each client is assigned a Project Manager that makes sure that the project is conducted timely, efficiently, and according to the plan.

In Arithmos we have opted for introducing the joint position of Project Manager & Business Analyst. This ensures that the client does not have to deal with the change of the reference person, and makes the collaboration smoother and more convenient for the client.

What most inspires you about working within this field?

The possibility to work with the clients, as one team, and bring to life complex projects that will improve the way clinical trials are managed. Also, the Life Sciences industry is constantly evolving, so there is a lot of space for growth and innovating!

What are the top skills that a Project Manager / Business Analyst in Life Sciences should develop?

  • Analytical skills – you need to have a structured approach to the tasks and know how to step back, see the whole picture, and analyse the situation.
  • Attention to details – as a Project Manager you need to keep track of multiple tasks and liaise with multiple stakeholders at the same time.
  • Technical knowledge – although having a technical background is not obligatory, it helps in ensuring a high level of quality for the project. You also need to always stay on the forefront of the newest updates in the technology field.

Marco Pastore Business Analyst and Project Manager

What are your personal values?

Reliability – if you have taken on a task, you need to deliver it, because if one piece is missing from a project, it puts the rest of the work at risk. I also believe that things should be done with passion. Loving what you do allows you to always strive for excellence.

What are your main interests outside of work?

I am addicted to technology! I have a whole collection of gadgets. Most of them are related to sports, like smart watches and activity trackers. I have used them a lot during my trainings, as I am very keen to marathon running and triathlons. For example, I have done a half Ironman triathlon and have ran the full Valencia and Padova marathons.

Of course, I must mention that I am also a cat fan and I have 4 lovely kitties at home.

Arithmos careers

We are always looking for talented and motivated professionals ready to join us. Would you like to be part of our successful team? To find out more about our job openings click here.

 

Webinar: How to Perform a Successful Data Migration in Life Sciences

Data migration Life Sciences

Webinar: How to Perform a Successful Data Migration in Life Sciences

In Life Sciences industry a structured but lean approach to data migration is vital for success. Such approach not only ensures data integrity and consistency, but also minimizes the data migration impact on day-by-day business operations.

The webinar will describe the main risks and challenges of the data migration, ways to overcome them, and present a case study of data migration in pharmacovigilance.

Click here to learn more about the webinar and register your attendance

Date and time:

Thursday, May the 14th, 10:00 AM – 12:00 PM CET

The key learning outcomes will be:

  • How to define an adequate data migration strategy including data migration verification
  • The main steps in data migration
  • Understanding of the major challenges during the data migration and ways to overcome them

Presenter: 

Alessandro Longoni is a Senior Business Analyst & Project Manager of Arithmos. He has been working in the field of Life Sciences technology for 13 years and has particular expertise in pharmacovigilance and electronic data management.

Webinar: Agatha – Quality and Content Management Solution

Banner_Agatha Webinar

Webinar: Agatha – Quality and Content Management Solution

Arithmos with its partner Agatha Inc. is excited to invite you to a joint webinar. This webinar aims at presenting Agatha – a cloud-based Quality and Content Management tool for Life Sciences and Healthcare organizations. Agatha is dedicated to helping organizations such as hospitals, biotechnology, pharmaceutical and medical device companies as well as Contract Research Organizations optimize the management of their quality and clinical documentation and processes. The system is highly configurable, allowing for tailored customizations that fit the company’s workflow.

Click here to learn more about the webinar and register your attendance

Date and time:

Friday, April the 17th, 2020, 11:00 AM – 12:00 PM CEST.

The key learning outcomes will be:

  • How to use Agatha for the management of company’s quality and clinical documentation and processes
  • How to use a single tool order to streamline the collaboration between QA, Regulatory, and Clinical departments
  • Advantages of a pure cloud service compared to the service on premise

Presenters: 

  • Silvia Gabanti, Managing Director of Arithmos
  • Guillaume Gerard, Chief Operating Officer of Agatha Inc

Leadership in the Workplace: Angela Weston

International Women's Day

Leadership in the Workplace: Angela Weston

International Women’s Day takes place on March 8th and is an important day in the calendar as it celebrates the social, economic cultural and political achievements of women.  It’s theme this year is “An equal world is an enabled world”. Women today are still striving to close the gap in the workplace, and many seek out networking opportunities by sharing life experiences, philosophies and making new connections.

We have taken the opportunity to talk to Angela Weston, Chief Commercial Officer, PM Holding. Angela has been an influential leader for over 20 years, working with multinational companies in the pharmaceutical, medical device and CRO environments. Angela has an impressive track record of implementing strategies to support global sales, marketing and proposal management.

Do you think there are any differences between how men and women lead?

Yes – I think it is clear in our approaches.  Women tend to be far more critical about their own abilities; instead of being proud of their achievements. There is always a need to strive for excellence and for a woman this can sometimes influence decision-making. Men can come across as more confident in certain situations and this can sometimes work to their advantage and sometime not

A real challenge that remains today is the lack of progress being made across many industries in women climbing the corporate ladder although the glass ceiling is beginning to crack. Women in board room positions fell in 2019, but I see a change afoot.

What are some patterns you’ve noticed over the years about how women develop and manage their careers?

Women have a natural ability to multi-task and prioritise with; family, career, managing social commitments and maintaining outside of work friends and interests. I may be biased, but I think women and multi-tasking are ahead of the curve in this respect. Example: I can run a Global pipeline call, have a glass of wine in hand and be ironing and all at the same time!

What are the biggest challenges you face in management and what keeps you pushing forward?

The biggest challenge is always people management – my role requires me to work cross functionally and with multiple stakeholders. It is important that the work environment is a fun, collaborative but productive one. I always go the extra mile to ensure my team are happy, motivated and well looked after – it’s a big and very important part of my day to day life.

I am always pushing myself and my teams, to exceed in all that they do, being a driven person doesn’t allow me much time to sit still for long – however this approach has always brought success and has allowed me to have choices throughout my career.

Who is one female entrepreneur who you personally admire and why?

Margaret Thatcher, the “Iron Lady” of British politics, she was not afraid to speak her mind and she was driven by her passion and beliefs – she went above and beyond to achieve her goals.

What advice do you have for the next generation of women leaders?

  • Reach for the stars – dream big, you can do anything you want to when you put your mind to it.
  • Have a can-do attitude.
  • Invest time and effort to learn, don’t be afraid to step outside your comfort zone.

What are you most passionate about?

Health, wealth and happiness.

The health and wellbeing of family, friends and colleagues is very important to me. I also have tremendous passion for business and relish new challenges and contributing to the Healthcare Industry gives me a good feeling.

What are your personal values?

Integrity – this has helped me throughout my career, I believe it’s important to be honest and transparent even if the message you sometimes communicate is sometimes a difficult one.

What is your favourite film, website and brand?

  • Top Gun
  • Amazon
  • Channel

Thank you for taking the time to talk to us today.

 

Learn the team’s favourite part of working in Arithmos

Best aspect of work in Arithmos

Learn the team’s favourite part of working in Arithmos

Arithmos is celebrating its 10th anniversary this year! Founded in 2010, Arithmos has grown substantially during its time in business and now boasts experienced team with outstanding expertise. We took this opportunity to ask some of our colleagues to share their favourite part of their job and connection to our goal – accompany our Life Sciences clients on the Digital Transformation path.

The best part about working in Arithmos

Alessandro Longoni, Sr. Project Manager & Business Analyst

“For me the best thing about working in Arithmos is professional challenges. As Arithmos provides 360-degree support in Digital Transformation, we deal with projects that involve more than just a product – it’s a complex combination of services, solutions, technical competencies and change management. Working on such projects is challenging, but very motivating.”

 Pedro M. Lledo, Account Manager 

Teamwork is the keyword. They know how to listen you and understand each other. I feel great among all of them. I’ve been feeling like adopted by a great family and they appreciate what you do for them, and they also do the best for you. Great team!”

 Marco Pastore, Project Manager & Business Analyst

“The best part of my work is innovation! In Arithmos we focus on delivering innovation – whether it is innovative solutions, approaches or technologies. Staying on the forefront of technological developments is challenging, but extremely rewarding. It also ensures that we deliver the best support to our clients on their Digital Transformation journey.”

 Michele Montanari, Life Sciences Application Manager

“I like the collaborative spirit of Arithmos. Due to their innovative nature, our projects bring together people with different backgrounds and different experience. This mix of past experience, present aspirations and clear vision of future allows us to deliver latest technology solutions to our Life Sciences customers.”

Francesco Danzi, Business Development Associate

“My favourite part of Arithmos is the synergy – there is a great alignment between teams! It was the first thing that I have noticed when I have joined Arithmos – there is no silos between departments, and everyone is working as one team. No one is ever left behind, not even the newest one!”

Career

Arithmos is always looking for talented and motivated resources ready to join our successful team! We are currently seeking a QA & CSV Officer in Italy. If you think you are the right person for the job, please submit your CV info@arithmostech.com.

COVID-19: Proactive Action Plan

COVID-19

COVID-19: Proactive Action Plan

Verona, Italy (25 February 2020) – In response to the news from the Italian Authorities, PM Holding Companies (CROS NTArithmos, seQure) are taking the following actions as a precautionary measure in our Italian offices with immediate effect:

STAGE 1: Team Lead Mapping

A complete mapping of staff, internal and external, has been done. For strategic positions and responsibilities, the key backups have been identified to provide continuity and succession of our services.

 STAGE 2: Risk Plan

As a global company many of our employees work from home. However, a contingency plan that allows our Italian staff to work from home during this precautionary period has activated to ensure business as usual across projects.

STAGE 3: Travel Schedule

In response to the Northern Italy lockdown: travel plans in this region for our employees have been rearranged and customers have been advised accordingly, teleconferencing will remain an active channel during this period.

STAGE 4: Continuous Review and Assessment

Our risk plan is under continuous review and assessment. Our primary concern is the health of our employees, customers, partners and suppliers. Please be assured it is business as usual.

If you have any additional concerns, please email us at info@arithmostech.com and we will be in touch shortly.

Would you like to learn more about how Arithmos and its sister companies are delivering better outcomes in times of crisis? Read the interview with our CEO Paolo Morelli “Navigating Business in Times of COVID-19”

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