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Insife is dedicated to expert consulting and technology services for drug safety (pharmacovigilance, or PV) organizations. We are delivering innovative solutions and insights to pharma/biotech and agencies in Europe, North America and Asia. Insife is headquartered in Denmark, with additional offices in the US, India, Germany and the UK.
Our expertise includes a wide understanding of the pharma value chain with a knowledge of where to apply digital transformation in the life sciences industry and specifically drug safety through process optimization and automation.
Insife has developed a comprehensive and scalable end-to-end (E2E) Safety Database called HALOPV. With HALOPV, drug safety organizations can manage and automate any process, e.g. ICSR processing, submissions, PSMF management. These capabilities have been applied across Insife’s client base, which ranges from pharma top 10 to medium and small size businesses. Insife strives to develop and implement forward thinking services and technology that empowers its customers and advances the safety of patients.
Vision and Mission
Insife was founded with a vision of becoming a global leader in life sciences by developing transformative solutions tailored to benefiting customers and their patients. Our mission is to reshape drug safety through process optimization and automation with an ongoing commitment to transparency and delivery excellence for all customers.
Products & Services
Insife provides a comprehensive offering of end-to-end (E2E) business process, organization and technology solutions that address the industry’s most pressing challenges.
Principal service and product offerings include:
E2E Drug Safety Consulting and Technology Capabilities
Insife offers detailed and end-to-end consulting and technology services to help companies navigate an increasingly complex landscape. Areas of expertise include:
- Global E2E PV Optimization (Process, Organization, Technology)
- Transformative Decision-Making methodology
- Program and Change Management
- PV IT Blueprint and Argus Specialists
PV Oversight and Advanced Automation
Insife’s E2E Safety Database, HALOPV, places an automated “halo” around drug safety for pharma and biotech companies and agencies, providing comprehensive workflows and tools that help ensure regulatory compliance. HALOPV modules address all aspects of drug safety assurance including product safety master files (PMSFs), safety data exchange agreements (SDEAs), individual case safety report (ICSR), distribution and submission tracking, aggregate reporting, signals, risk management, literature, regulatory submissions, complaints, quality control, and device vigilance.
The latest version, HALOPV 2.3, was released in November 2020.
- Drug Safety Intelligence
Incoming safety information can be pre-processed by AI technology to achieve dramatically higher efficiency and scalability. Insife’s AI Data Analyzer tool is a supervised model for assessing data points using decision trees on big data sets. It utilizes existing datasets (e.g. FAERS) and in-house data, combining these with AI methods to transform unstructured data to structured information (with translation of local text to English) to triage and assess new safety information for relevance, causality, regulatory listings, seriousness, etc. Drug Safety Intelligence forms a combined intake automator and signal detection tool, providing analytical capabilities in real-time to assess if the new data warrants further safety investigation. Not only is it able to determine if an ICSR is to be processed, it can also format and ready the data for import in E2B(R3) format.
Drug Safety Cloud (GxP) Hosting and System Implementation
Insife.cloud is an innovative cloud-based IT platform that provides a total one-stop-shop for pharmacovigilance drug safety and GxP compliance solutions, allowing companies to implement processes faster, smarter, and more cost-effectively. The platform provides access to an integrated suite of technologies and applications. These include:
- HALOPV: E2E Safety Database and new industry standard for PV process management and automation.
- Argus Safety: Safety Database from Oracle™ with more than 400 clients worldwide. Insife offers implementation of Argus safety in a standard setup in the Insife.cloud environment for top performance at a very low price point. Argus integrates with HALOPV for regulatory compliance tracking, aggregate reporting and advanced workflow management.
- Axway Gateway: Axway is part of the suite as a gateway for regulatory submissions to authorities and partners.
- AWS Suite: A comprehensive range of Amazon Web Service (AWS) business tools including the AWS Translate neural machine language translation, AWS Comprehend natural language processing (NLP) service that uses machine learning to find insights and relationships from unstructured data, and AWS QuickSight Analytics for monitoring an entire server-based environment for performance metrics, etc.
Industry Thought Leadership
GRIP (Global Regulatory Intelligence Club for Pharmacovigilance) is an Insife-hosted global network of PV professionals that reviews the top challenges and issues in the industry, analyses benchmarking data, discusses latest technology and trends, and shares how companies are addressing and managing global PV requirements.
Company History and Structure
Insife’s CEO, Martin Holm-Petersen, founded the company in July 2017 at Hellerup, north of Copenhagen. A decade working in Big Pharma and subsequently heading up global pharmaceutical network PVtech led Mr. Holm-Petersen to the realization that most pharma companies were missing the same basic ingredients needed to optimize performance. Mr. Holm-Petersen created Insife with the objective of reshaping drug safety through smarter technology and tailored services.
Over its first three years of operations, Insife has been growing revenues at an average rate of 300% annually. Significant milestones include the opening of Insife India at Bangalore in December 2018, the introduction of HALOPV early in 2019 shortly followed by the introduction of Insife.cloud customer operations, and the opening of the North American subsidiary Insife US, based in Jersey City, NJ.
By end of 2019, HALOPV had been adopted by its first top 10 pharma customer and by November 2020 was also adopted by a top 5 pharma company. At the end of 2020, Insife opened a Cologne-based subsidiary, Insife Germany, while in 2021 established a presence in the UK by opening an office in Cambridge.
The company’s management team includes Peter Stroyer Pallesen (CTO), Wilfred Gilich (Head of US Operations), Anne Tinggaard (Head of EMEA Operations), Praveen Gupta (Head of Product Development), Karuna Jeevanandhan (Head of India Operations) and Marc Zittartz (Managing Director, Germany).
Quality, Regulatory and Standards
Insife’s products and operations are subject to rigorous quality standards. All operations meet ISO 9001 and ISO 27001 quality standards as well as being GxP compliant. Insife also complies with all 21CFR part 11 and EU Annex 11 data security and provenance guidelines as well as EMA GVP modules.
Insife’s internal quality processes are guided by Standard Operating Procedures (SOPs) and incorporated into an integrated management system (IMS) to assure compliance with all identified standards for pharmacovigilance as well as ISO 9001 and ISO 27001. The Insife IMS (Quality and Information Security Management System) has been audited by numerous pharmaceutical companies as well as regulatory agencies.
HALOPV and Argus Safety are delivered with pre-approved validation packages to radically accelerate speed of deployment and maintenance. The company’s SaaS model includes annual and bi-annual upgrades. Insife can also provide specific customer support to comply with regulatory audits and inspections.