We are the Pharmacovigilance experts
Technology. Process optimization. Strategy and realization.
#1 Provider in Northern Europe
Process, organization, compliance, technology
Our consulting engagements will get you there. Expertise and knowledge is close by and we stay with you until we have delivered what is promised.
We deliver results to pharma companies
We understand pharma companies and the pharma value chain, as well as the regulatory environment in which pharma operates. We also understand technology and the strong current that flows through industries as well as society - to digitally redefine and transform businesses. Trust us to help you harness the power of technology and optimize process and organization in order to deliver what is required, both today and tomorrow.
We can help you deliver Argus safety database projects to deliver efficiency and meet regulatory timelines
New regulatory requirements such as EudraVigilance ICSR downloads, centralized reporting or E2b(R3) messaging and the new WHODrug B3/C3 dictionary are impacting the installations of safety databases across the industry. We can help you address the challenges and assist you through the upgrade, initial deployment or migration. We are experts in Argus Safety and can help you deliver an efficient and cost effective setup.
Set strategic direction for your technology investments to meet organizational goals
Never before has there been more complexity in operating and delivering PV, across global compliance, product surveillance, risk management, safety governance and communication etc. All across an increasing amount of data sources and pressures to communicate and be proactive. We can help you build a roadmap of change and navigate priorities, in close collaboration with your experts and PV leadership team
Integrated and ready to perform - the ideal approach for small and medium size pharma and CROs is here
Technology has helped PV and Clinical deliver through decades of growing trial complexity and ICSR volumes. New technologies are emerging to further improve capabilities. Join our platform approach as we deliver a seamless integration of tools that will make life in the department easier right now, across analytical data warehousing, information processing, reporting and global compliance, all while providing exciting options to take in future oriented concepts.
We bring best-of-breed technology to fruition
HALO PV is an innovative solution to manage PV processes across the global span of operations. Enables effective handling of PV agreements, Regulatory intelligence and reporting rules, capturing ICSRs, follow-ups and tracking submissions, PSPs/MRPs and social media scanning, risk management as well as CAPA tracking. Includes a number of dashboards to maintain oversight of processes. Includes a number of integrations and automations as standard.
Argus Safety is the world’s foremost, fully-featured safety database, with more than 20 years in the market and over 200 clients worldwide. Insife offers Argus safety in a Basic, Standard and Enterprise setup in the Insife cloud environment for top performance at a very low price point. Oracle B2B is part of the suite, for gateway E2b submissions to Authorities and partners. OBIEE is included in the Enterprise edition for advanced analytics and reporting capabilities.