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Choosing the Right Technology for a Complex Clinical Oversight Project

Clinical Trial Oversight Technology Solution

Choosing the Right Technology for a Complex Clinical Oversight Project


Our client is a global pharmaceutical company with almost 30 affiliates around the world. Keen to set up a clinical oversight system, they have taken a decision to introduce a technology solution to conduct oversight in highly efficient and compliant way.

The clinical oversight solution had to be compliant with the ICH GCP E6 (R2) addendum and allow to supervise the work of the CROs in efficient way, ensuring that all the quality requirements were met.

The CROs involved in this project are the leaders in the market and already have their own systems to manage clinical trials, however, they are providing study updates in their own format.

Our client identified Arithmos as the right partner in the conduction of vendor selection, due to the vast experience of our team which allowed us to drive this complex phase successfully and reduce the company’s internal effort and the impact on the business.

We have also supported the client in the implementation phase to guarantee the business continuity and focus on the project objectives and business goals.


The main challenge was engaging all the interested parties in the process of identifying and implementing the oversight technology solution:

  • Stakeholders: customer, technology vendor, consulting suppliers, CROs
  • Departments: R&D, ICT, CSV, Pharmacovigilance, QA, Legal, Procurement

Bridging the communication and functionality gap between the stakeholders was vitally important, as it allows:

  • Avoiding the silos between the departments
  • Considering all the expectations, choosing the solution that works the best across the company
  • Reducing the risk of misalignments between company requirements and solution implemented

Arithmos’ approach

We divided the project in three phases:

  • Business Requirements
  • Vendor Selection and Assessment
  • Vendor Confirmation

We have optimised the collection of business requirements while working with small groups from each department to define 5-7 key needs.

During the Vendor Selection and Assessment phase we have adopted a 5-step approach that allowed us to identify the best solutions that respond to the client’s key needs:

  • Compiled a list of 3-5 vendors
  • Carried out a survey to gather information regarding the size of the company, its capabilities, certifications, product history and roadmap, etc
  • Requested demos focused on requirements collected from the client
  • Requested ballparks
  • Compiled an assessment report with evaluation matrix based on the survey and demo outcomes to identify vendor had the highest weighted score

Once the vendor was chosen, the client conducted an audit to verify the preferred vendor’s compliance and processes.

Successful Outcome

Structured analytical approach has allowed us to identify the right technology clinical oversight solution that satisfies the requirements of different stakeholders minimising the impact for all business area involved. The proposed solution:

  • Gives a global overview of all the client’s vendors involved in each study
  • Converts non-homogeneous data into a format that is homogeneous and allows easy comparison, control and performance analysis, for example the visit frequency analysis

Arithmos and the client have worked very closely and tirelessly to select a technology solution that allows to conduct oversight in an efficient way and in compliance with the ICH GCP E6 (R2) addendum. The selection phase was followed by Phase II (tool implementation) and Phase III (support and maintenance).

The relationship created and the collaboration and communication processes defined during the software vendor selection between Arithmos and the client have definitely added value to the following phases, shortening the organisational stage and related project risks and making the working team more efficient.

Click here learn how we can support you with choosing the right oversight solution

Looking for a technology oversigth solution? Contact us!

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?”


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Upon reading the Information Notice outlined above:

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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.
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The data subject’s refusal to give consent will result in the company’s failure to process their data for marketing purposes.


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Q&A: Kairos – Data Analytics and Reporting Solution

Kairos Q&A Data Analytics and Reporting Tool

Q&A: Kairos – Data Analytics and Reporting Solution

Kairos, Data Analytics and Reporting solution for PharmacovigilanceLast year, Arithmos, a provider of innovative IT solutions with a specific focus on the Life Sciences, announced a partnership agreement with E-project, a consulting and system integration company. Together they have brought to the market Kairos, a unique Data Analytics and Reporting solution for pharmacovigilance.

Kairos gives Life Science 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.

We have talked to Silvia Gabanti, Arithmos’ Managing Director, to learn more about this new solution.

How can Kairos improve the pharmacovigilance processes and ease the life of the pharmacovigilance team?

First of all, Kairos allows to produce PSUR/PBRER and other safety reports, automatically, in a simple and error-free manner. It excludes the factor of human error.

Secondly, it allows to optimize the performance of the pharmacovigilance department by creating reports to measure KPIs.

Thirdly, it removes the silos between Pharmacovigilance and Regulatory and Clinical departments supporting the data reconciliation in the most effective way.

Silvia Gabanti Managing Director ArithmosCan other departments use Kairos?

Absolutely, and this makes Kairos unique. It helps to make sense of data regardless of its origin. Now Life Science companies gather enormous amounts of data from different sources, like EDCs and safety systems, and mostly use it to ensure compliance. However, data is much more than this.

Data analysis allows to optimize the processes while reducing the team’s effort and the gap between operational units. This helps to make faster and safer decision and improves the business efficiency. Life Science companies can grow business and act proactively, not only reactively.

Although Kairos was born as a pharmacovigilance reporting and data analytics solution, it can also be used horizontally across the company. Departments from Clinical to Marketing can use it to analyse their data, create reports, and share them easily.

Kairos allows you to break down the silos between the departments.

What makes Kairos a unique solution on the market?

Kairos is the result of a synergy between teams with a decade of experience in business intelligence, data analytics, pharmacovigilance, and Life Sciences in general. It is more than just a piece of technology. Kairos includes the solution itself, consultancy, report building, and fine tuning.

Such a combination makes Kairos a powerful tool that is dispensed with low license and maintenance costs.

How can you describe Kairos’ price model?

It is scalable. You start with the minimum investment with the licenses and configuration. If you would like to add new reports, or extend Kairos to other departments, you can easily do it.

Can Kairos be customised?

Yes, absolutely. The whole system is customisable. The first thing we do is understand our clients business needs and type of reporting required. Then we can customize Kairos based on these expectations.

The next step is to give the clients detailed training. We want them to be completely independent and able to change the format, design or data, themselves, to fit their organisation.

How does Kairos fit the bigger Arithmos goals?

We strive to provide 360-degree support, to our clients, on the road to Digital Transformation. Kairos is another step towards this goal.  It allows Arithmos to give more support to the clients.

We also believe in a proactive approach to safety and regulatory compliance. Harnessing the power of data that Kairos contributes to it.

Last, but not the least, we preach efficiency in operations and processes. Introduction of a tool that can operate horizontally and not vertically, allows to save on IT investments and optimize the departments’ work by breaking down the silos.

Want to learn more about Kairos? Contact Arithmos now to see the demo of the solution.

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


  • 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

Webinar Q&A: Agatha – Quality and Content Management Solution

Agatha Quality and Content Management Solution

Webinar Q&A: Agatha – Quality and Content Management Solution

Biotechnology, pharmaceutical, and medical device companies develop highly complex products. For them, accuracy, consistency, efficiency, and quality are not goals; they are imperatives because the medicines, therapies, and devices they make can improve the quality of patients’ lives and safeguard their health.

On April 17, Arithmos with its partner Agatha Inc. hosted a complimentary webinar on Agatha – a cloud-based Quality and Content Management tool for Life Sciences and healthcare organizations. Agatha addresses the imperatives for their core business processes like managing clinical trials, optimising quality processes, and organising regulatory submissions. The system is highly configurable, allowing for tailored customizations that fit the company’s workflow.

The webinar was conducted by:

  • 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 where she developed experience in applications for pharmacovigilance and clinical trials. 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.
  • Guillaume Gerard, Chief Operating Officer of Agatha Inc. For the past 15 years Guillaume has been helping Lifesciences organizations worldwide to deliver cloud-based content management applications. His areas of expertise include the compliance aspects and architecture of such systems, as well as the functional expertise on the clinical document management side (Trial Master File) and Quality Management.

Continue reading to discover the questions from the Q&A session from the webinar.

Register today to get access to the webinar recording

What is Agatha’s policy for data backup?

Agatha handles all aspects of the data center operations, including regular backups of all data.  All customer data are backed up daily, and daily backups are retained for 15 days.

It also provides the ability for customers to export all customer data (files, audit logs, metadata) at any time.

Is Agatha compliant with GDPR?

GDPR is a comprehensive privacy regulatory requirement.  Agatha is fully compliant with the requirements in regard to how it stores data and collects information.  There are some aspects of GDPR which are the responsibility of the business entity, for example naming a Privacy Officer.

Are document lifecycle statuses customizable?

Yes, lifecycle stages and other aspects of the review and approval workflows can be fully configured. That includes changing labels, adding steps, reordering steps and changing workflows from serial to parallel structures.

Are electronic signatures compliant to CFR21 part 11?

Yes, electronic signatures within Agatha are fully compliant with health authority requirements.Beyond signatures, Agatha is completely compliant with the FDA’s CFR21 Part 11. We maintain a CFR 21 Part 11 compliance checklist for every release of our service, and any customer can receive a compliance letter that can be used during audits.

Are activities tracked into an audit trail?

Yes, all activities are captured. This includes operations on documents as well as access and any change of settings. When an audit is performed, everything that has been collected in the audit trail process and stored can be provided directly to the auditor via a login with auditor access.

Is it possible to load data via an api from external applications (eg. eTMF, CTMS, EDC, …) and if yes, what kind of data can be loaded, only documents or also xml, json, xls?

It is possible – there is a full set of APIs available that allows data to be loaded, and external applications to be integrated.

Can documents have an expiration date?

Yes, documents can have an expiration date. This can be done using a “valid until” metadata, and processes can be triggered based on that metadata.

Could Agatha be used during the product development stages?

Absolutely. Many aspects of the Agatha solution are appropriate prior to the clinical trial phase, for example management of SOPs and collection of regulatory documentation.

Can Agatha manage the migration of legacy documents?

Yes, most projects include migration steps. There is an import tool that lets the client map data from a source system to Agatha and complete the import.

Is it possible to enable two-factor authentication (e.g. username & password plus SMS) in Agatha application?

Yes, two-factor authentication is the  standard model for the use of Agatha. Two-factor authentication is enabled  on a per-client basis.

Are there any penetration tests that could be shared with customers?

Yes, as part of Agatha hosting service penetration tests are conducted yearly. Reports and results are made available to clients during audits.

During the webinar it was mentioned that Agatha is cost effective. How does it price compare to the competition?

Agatha provides the best value among similar products because, as a ready-to-use and pre-validated system,  it is less expensive to bring into product and on-board users.   It also has lower subscription prices, because it does not operate on top of another product platform. It also has truly packaged modules, as it was shown during the webinar.  Typically, it is 2 times more affordable than the competition.

If you are interested in a specific quote, contact us for a brief conversation. We will ensure we understand the specific functionality you need and the number of users and provide the best offer.

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


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

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.

[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.

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