AB Cube S.A.S. Basic Information, Manufacturing Base, Sales Area, and Competitors
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Sr. No. |
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Description |
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Company Name |
AB Cube S.A.S. |
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Website |
www.ab-cube.com |
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Established Date |
2006 |
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Headquartered |
France |
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Market Position/ History |
AB Cube has been at the forefront of innovative vigilance solutions since 2006 when they introduced the very first cloud-based vigilance solution. In 2008, they demonstrated their commitment to the greater good by delivering a pro bono PV system to the French academic community. By 2015, they had launched the first cosmetovigilance solution, with L'Oréal implementing it across all their divisions and successfully migrating 350,000 cases. In November 2017, AB Cube achieved another milestone by becoming fully E2B (R3) native, a capability extended to all their clients. In 2018, they introduced ITAP, a universally compatible triage tool that automates ICSR activities, increasing efficiency by up to 85%. The year 2020 saw the launch of the multivigilance cloud-based solution, SafetyEasy Suite, designed to meet the challenges of international safety regulations, including combination product reporting. Alongside, MigEasy was launched to facilitate seamless and rapid data migration and integration into the SafetyEasy Suite. In 2021, AB Cube was selected by ANSM, the fifth largest provider of pharmacovigilance cases globally, to provide their PV solution. In 2022, AB Cube was acquired by BID Equity, positioning them to accelerate growth and establish themselves as a worldwide leader in multivigilance solutions. |
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Sales Area |
Worldwide |
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Competitors |
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CEO |
Matthieu Doresse |
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Ownership Type |
Private |
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Contact Information |
Address: 23 rue de Bruxelles 75009, Paris, France Tel: +33 185 34 94 79 |
Business Segment/ Overview:
AB Cube is a leader in providing comprehensive vigilance solutions tailored to the diverse needs of various organizations, ranging from research centers to prominent pharmaceutical leaders and emerging biotechnology firms. Their solutions ensure patient safety and multivigilance across a wide range of domains, including pharmacovigilance, medical device safety, biovigilance, nutrivigilance, and cosmetovigilance through their CosmEthics platform.
The product categories under SafetyEasy Suite segment includes:
• Multivigilance
• Pharmacovigilance
• MedDevice Vigilance
• Cosmetovigilance
• Nutrivigilance
The SafetyEasy Suite addresses the complex challenges of international safety regulations, including combination product reporting, by offering dedicated solutions for each vigilance domain. AB Cube's commitment to staying ahead of regulatory requirements was demonstrated in November 2017 when they became fully E2B (R3) native, a capability that was extended to all their clients, ensuring compliance and flexibility through their SaaS model.
Pharmacovigilance and Drug Safety Software Product Types Specification
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Product |
Product Description |
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Pharmacovigilance |
Features: Report generation:
Tools:
Data entry:
Administration:
Integration:
Benefits: Secure & compliant SAAS: HDS compliant server hosting for sensitive healthcare information, 2 hours Disaster Recovery Plan (DRP), HIPAA compliant, SSL web access, 99.99% SLA guaranteed, 21 CFR part 11 Audit Trail, ISO 27001 data center (Tiers III plus) Intuitive user interface: Automatically populated fields, narrative generation in just one click, smart MedDRA coding, integrated query module, fully customisable workflow 2 week implementation: Digitise your excel-based and paper-trail regulatory reporting with SafetyEasy® Suite in less than 2 weeks One-click submission: Smart E2B XML creator (R2, R3), multiple formats supported (MedWatch, CIOMS, Meddev, etc.) and email submission No hidden cost: Transparent terms and conditions since Day 1. Unlimited number of users, quarterly upgrades and support included in your licens Fully validated: GAMP 5 validation, online validation dossier available, validation dossier updated with each upgrade. Minimum validation effort required from the users Oher features: Boost Efficiency:
Powerful Reporting: Spontaneously generate submission ready regulatory reports automatically populated with entered data.
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Recent Developments:
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Year |
Latest News |
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June 2024 |
Launch of next-AI generation Galaxy modules AB Cube has introduced new modules that significantly enhance their core SafetyEasy Suite, making multivigilance operations faster, more efficient, and scalable. These advancements integrate business intelligence and automation to optimize performance.
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November 2022 |
ANSM joins forces with AB Cube again, reporting of COVID19 national vaccination program AB Cube has launched IntakEasy, their second project with ANSM, shortly after deploying their flagship pharmacovigilance software, SafetyEasy Suite. This new automatic intake tool aims to expedite the safety reporting processes for adverse events related to the SARS-CoV-2 vaccination program. As France's national vaccination program accelerates, the number of reported adverse events is increasing. The French Adverse Health Event Reporting Portal, accessible to both health professionals and the public, previously required raw data entered by the public to be manually processed by regional pharmacovigilance centers (CRPV). This manual process was time-consuming and labor-intensive. To address this, AB Cube rapidly deployed IntakEasy, designed specifically for ANSM. This tool links the national adverse health event reporting portal with the national pharmacovigilance database (ANPV), automating case intake. Additionally, an artificial intelligence module assesses case severity, making processing 30 times faster than manual methods |
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June 2022 |
BID equity acquires ab cube, a leading software provider for pharmaceutical product safety The establishment of a new group of businesses in the areas of pharmaceutical, medical, and cosmetic safety and regulatory processes commences with AB CUBE as the foundation. The goal is to create a supplier that can handle every relevant international regulatory compliance requirement, including vigilance. |
Business Strategy
AB Cube S.A.S. has established itself as a leader in the field of pharmacovigilance and safety software through a combination of technological innovation, strategic partnerships, and a customer-centric approach. France, which ranks fifth in the world for pharmacovigilance cases, depends on AB Cube's 15 years of experience and technical adaptability. With the launch of IntakEasy, the partnership between ANSM and AB Cube has advanced after SafetyEasy Suite was implemented on April 6 as the country's pharmacovigilance database. This improvement will enable ANSM to more effectively handle the higher volume of cases and adverse effects resulting from the COVID-19 vaccination campaign, freeing up medical staff to concentrate on more serious cases.
The company has emphasized more on their technological innovation making it a significant part of their business strategy. Some of the technological innovation and product development include:
Flagship Products:
• SafetyEasy Suite: AB Cube's flagship pharmacovigilance software, designed to handle the comprehensive safety reporting needs of pharmaceutical companies, CROs, and regulatory bodies. It includes modules for pharmacovigilance, medical device safety, biovigilance, nutrivigilance, and cosmetovigilance.
• CosmEthics: A specialized module within SafetyEasy Suite for cosmetovigilance, catering to the unique requirements of the cosmetics industry.
Recent Product Launches:
• CasEasy AI: An AI-driven module employing Natural Language Processing (NLP) to automate the conversion of Individual Case Safety Reports (ICSR) into cases within the SafetyEasy Suite, reducing case intake effort by 70%.
• Business Intelligence (BI): Leveraging Qlik Sense technology, this solution offers advanced dashboards and enhanced case analytics capabilities.
• Converter: Incorporates Optical Character Recognition (OCR) to automatically generate case information from uploaded forms such as CIOMS, MedWatch, or SAE, saving significant time for teams.
• Literature Manager: Connects to PubMed and other literature libraries to streamline the process of finding, analyzing, reviewing, and creating potential cases from academic articles.
• IntakEasy: An automatic intake tool designed for ANSM, linking the national adverse health event reporting portal with the national pharmacovigilance database (ANPV), and incorporating AI to assess case severity, making processing 30 times faster.
Another significant business strategy of the company includes strategic partnerships and market expansion which encompasses collaboration with some regulatory bodies. For instance, AB Cube's partnership with ANSM, the French National Agency for the Safety of Medicines and Health Products, exemplifies their ability to work with regulatory bodies to streamline and enhance safety reporting processes. This collaboration includes the deployment of SafetyEasy Suite as the national pharmacovigilance database and the launch of IntakEasy for automating case intake and processing. Similarly, in 2008, AB Cube delivered a pro bono PV system to the French academic community, demonstrating their commitment to the greater good and establishing trust and goodwill within the academic and research sectors.
Apart from this, the company has a market expansion business strategy which helped company to have more than 400 databases installed in more than 43 countries, having more than 2000 safety users and more than 2M ICSRs. This also made researchers who are at the forefront of life sciences innovation in order to meet safety laws. Moreover, the acquisition by BID Equity in 2022 is a strategic move to accelerate growth and position AB Cube as a worldwide leader in multivigilance solutions.
Lastly, the company mainly focuses on the customer centric approach and maintaining their client base through providing specific needs of various industries, including pharmaceuticals, medical devices, biotechnology, nutrition, and cosmetics. The suite is highly flexible, allowing for customization to meet the unique requirements of each client.
AB Cube's solutions are designed to be quickly installed, easy to use, and fully evolutive, ensuring that clients can adapt to changing regulatory environments and operational needs. Moreover, all products are validated according to GAMP 5 and FDA 21 CFR part 11, ensuring that they meet the highest standards of regulatory compliance. They actively seek and incorporate feedback from clients to ensure that their products remain relevant, effective, and user-friendly.
The key components of AB Cube's business strategy are customer-centricity, strategic alliances, technological innovation, and ongoing improvement. AB Cube is well-positioned to continue growing and securing its position as a leader in the multivigilance and safety software market by concentrating on creating innovative, integrated solutions and maintaining strong connections with customers and regulatory agencies.
S.W.O.T Analysis
Strength
- The company has a long history and more experience in the software field. The company has more than 16 years making it an established player in the market.
- The company has diverse clientele having 400 and more database installed worldwide with more than 2000 safety easy users.
- The company also has a worldwide global presence having a established presence in more than 43 countries. This has helped the company to have revenue generation from many countries and having growth in different markets.
- AB Cube’s products are designed to meet strict regulatory requirements in the healthcare and pharmaceutical industries, which is a significant strength given the complex and evolving nature of these regulations.
- The company offers innovative software solutions that are compliant with regulatory requirements. Their solutions often incorporate advanced technologies such as AI to enhance data analysis and reporting capabilities.
- AB Cube has a strong focus on vigilance systems, particularly in pharmacovigilance, medical device vigilance, and cosmetovigilance. This specialization allows them to develop deep expertise and sophisticated solutions tailored to these industries.
Weakness
- As a specialized company, scaling operations to meet global demand or rapidly expanding their product line may present challenges, especially in terms of maintaining quality and compliance.
Opportunity
- There is significant potential for growth in emerging markets where regulatory requirements for pharmacovigilance are becoming stricter. Expanding into regions such as Asia-Pacific, Latin America, and the Middle East could present new opportunities.
- Continued advancements in AI, machine learning, and big data analytics present opportunities for AB Cube to enhance its product offerings, providing even more value to clients through improved data processing and analysis.
- Forming strategic partnerships with other technology providers, pharmaceutical companies, or regulatory bodies could enhance AB Cube’s market position and open up new revenue streams.
Threats
- Competition from both established players and new competitors may result in price competition, lower profit margins, and even a loss of market share.
- If AB Cube is unable to rapidly modify their software solutions to comply with new standards, they may be in threat from sudden changes in regulatory requirements.
