News / Media
Insife awarded contract to deliver state-of-the-art vigilance technology platform for the MHRA
Insife has been awarded a contract for the delivery of a new state-of-the-art vigilance technology for the Medicines and Healthcare products Regulatory Agency (MHRA), which will help transform how the MHRA manages patient safety for all regulated healthcare products and establish a more responsive surveillance system.
The power of automated drug safety as an API
The AI Data Analyzer project has truly been rewarding in terms of understanding how cost-effective AI can be utilized for drug safety. The project was formally endorsed for closure by Innobooster / Innovationsfonden late last week. We are now introducing the API to the market under the name "Drug Safety Intelligence". Read more about it: https://www.insife.com/drug-safety-intelligence
Now certified by UMC for WHODRUG B3/C3 and Link Korea
We are among a few companies that have a fully ready platform to submit E2B(R3) files to Korea, using WHODrug C3 and Link Korea dictionaries. Check out UMC's list of WHODrug Link Korea ready platforms here: https://www.who-umc.org/media/165856/pv-platform-implementation-plans.pdf
Insife.cloud is saving 93% of carbon emissions
Our drug safety systems, such as HALOPV, are made available by Insife.cloud. This is an advanced GxP cloud service in partnership with AWS. Recent studies on the approach suggests far superior energy efficiency over on premise hosting. This is further enhanced by our flexible/point-in-time deployment of environments, e.g. for testing/validation, during upgrades, as well as intelligent scaling. In total, we can reduce carbon dioxide emission by more than 90%.
Insife is now engaging in a corporate wide ISO14001 certification, to further document and consider our environmental impact - as an extension of our efforts of cleaner hosting and already being paperless.
HALOPV 3.0 is coming in MAY!
It is almost here. HALOPV 3.0 will set new standards for pharmacovigilance organizations. Features full ICSR processing including case intake from various sources, such as forms, literature articles, and gateway / APIs. HALOPV furthermore features best-in-class requirements rules that auto-generates ICSR submissions into formats such as E2B(R3), E2B(R2) and CIOMS and integrates to major gateway products. Artificial intelligence is baked into the heart of the design, and allows for management of confidence and quality of the data. The UI is significantly redesigned, for a efficient and clean user experience. First commercial deployments are already planned for June 2021. #halopv #drugsafety #pharmacovigilance #artificialintelligence #insife
Insife CEO will present at DIA CSP
Insife's CEO Martin Holm-Petersen is presenting at the DIA CSP on 15-APR-2021. Check the link below for registration.
#insife #pharmacovigilance #drugsafety #artificialintelligence
Welcome Mike Roberts!
We are excited to have Mike Roberts join Insife on 06-APR-2021. With 25 years of experience in the Life Sciences industry, Mike strengthens our consulting practice for innovative drug safety solutions. Mike is also heading up the newly formed Insife UK, based in Cambridge, and will be joining our EMEA management team.
#mikeroberts #insife #drugsafety #unitedkingdom
Insife has now opened an affiliate in the United Kingdom, placed in Cambridge. We are looking forward to support UK-based organizations with drug safety (pharmacovigilance) technology and consulting needs.
#insife #drugsafety #pharmacovigilance #unitedkingdom #cambridge
AI Data Analyzer will be ready in May 2021
AI Data Analyzer contains a natural language processing engine that is capable of structuring unstructured information.
The platform is progressing and will be coming out for general use in May 2021. #ai #machinelearning #insife
What does Insife mean?
Insife. What does the name actually mean? Well, it is short for "Innovation. Insights. Solutions. For Life Sciences."
#insife #innovation #ai #drugsafety #pharmacovigilance #medicaldevices
New Senior Managing Consultant
We are excited to have Line Rasmussen join Insife. As of 01-MAR-2021, Line will be responsible for a number of our Scandinavian accounts as well as manage projects. #linerasmussen #insife #drugsafety #denmark
Comprehensive Offering of Consulting and Technology Services
If you are working within the field of Pharmacovigilance, you know how challenging it can be to drive changes. If you are looking to reshape your Pharmacovigilance experience, we are the global experts, across consulting and technology services. contact us on: email@example.com or read more on https://insife.com
Submitting ICSRs and periodic listings to agencies, partners, investigators and ethics committees?
HALOPV is ideal for effectively submitting ICSRs and periodic listings to agencies, partners, investigators and ethics committees. Go to https://halopv.com to read more. #drugsafety #pharmacovigilance #halopv #insife
New Associate Director and Project Leader
We are excited to have Søren Nørregaard Laursen join Insife. As of 01-JAN-2021, Søren will be joining the EMEA management team and be a key contributor to the consulting practice in Denmark. #sorenlaursen #insife #drugsafety #denmark
New Principal Consultant and Managing Director
We are excited to have Dr. Marc Zittartz join Insife on 01-JAN-2021. With more than 15 years of experience in the Life Sciences industry, Marc strengthens our consulting practice for innovative drug safety solutions. Marc is also heading up the newly formed Insife Germany, joining our EMEA management team.
#marczittartz #insife #drugsafety #germany
HALOPV - the best of the best
No other solution is able to manage and automate the PSMF (Pharmacovigilance System Master File) like HALOPV. Write to firstname.lastname@example.org for a demo or read more on https://halopv.com. It's pharmacovigilance made smarter!
#insife #halopv #psmf #drugsafety #pharmacovigilance #automation
Insife Germany is a reality
Insife Germany GmbH is now a reality. We are basing our German offices in Cologne. With this, we are able to better provide services for the central European drug safety / pharmacovigilance customers. #insife #germany #drugsafety #pharmacovigilance #halopv #argus
HALOPV is evolving
HALOPV is evolving. The latest version (2.3) is capable of effectively managing drug safety processes for a national agency. No other tool on the market offers the features and flexibility that allows for infinite workflows across ICSRs, compliants, counterfeits, risk management, quality investigations, aggregate report creation etc. E2B(R3), E2B(R2), device reporting support included.
That's Pharmacovigilance made smarter. Read more: https://halopv.com
#drugsafety #pharmacovigilance #halopv #insife
HALOPV 2.3 is released!
After months in the making, we are now releasing HALOPV 2.3. The most comprehensive system for managing pharmacovigilance just got better, with a number of new features, including a full scheduling engine for R2, R3 and CIOMS generation and submission. And device and combination product reporting. Read more: https://lnkd.in/eiz6UpM #halopv #drugsafety #pharmacovigilance #e2b #argus #arisg
GRIP: Medical Device and Combination Product Safety
We are hosting our next GRIP event on 08-DEC-2020, from 15:00-17:00 CET / 09:00-11:00 ET. Medical device and combination product safety is moving fast and will in 2021 become a major concern across Europe, US And Japan. Join the meeting to learn more and discuss with peers: https://lnkd.in/ebigRQJ #drugsafety #grip #insife #medicaldevice
We are ready for Brexit
We always thought the PSMF should be managed with global stakeholders in mind. Brexit requirements (see https://lnkd.in/gTktHV5) is a good example why it makes sense to take a solution and data-driven approach to PSMF management. The best solution out there is called HALOPV 2.3.
#psmf #drugsafety #insife #halopv #brexit
Nordic PV day 2020
Can artificial intelligence change our fundamental approach to signal detection - and how far is it today?
Those key questions will be the center of Insife CEO Martin Holm-Petersen's presentation at the virtual Nordic PV Day on 28 October 2020. For details about the event, click here: https://lnkd.in/gU6jdbk
#drugsafety #insife #aidataanalyzer #artificialintelligence
HALOPV - The great tool
Imagine a tool that automatically captures all out-bound submissions from your safety database (Argus and ArisG supported), identifies local submissions and distributes to partners and affiliates via secure links. Also, identifies late submissions and automatically prompts the local party for reasons. And of course documents it all in a GxP environment. Finally, allows for flexible reporting and dashboards to monitor, investigate and control per territory, reporting destination or partner, or even automatically generates the PSMF Annex F. All on the fly, of course.
That tool is called HALOPV. Version 2.3 is available November 2020.
#insife #halopv #icsr #compliance
Now public-private funded
Handling adverse event reporting has not been fundamentally changed in the last 20 years. The AI Data Analyzer initiative offers a solid way of building automation, based on big data. This way, we are combining strengths in numbers, and adding this into the concept of single ICSRs.
HALOPV 2.3 ready Autumn 2020
HALOPV 2.3 is almost ready and will be released in the Autumn. It is an exciting release including new ArisG E2b(R3)+ interface in addition to the existing Argus interface, Onedrive / Sharepoint and ESG (gateway) integration and plenty of new screens and controls. As an example, the Submission overview is an excellent way of keeping track of all outbound activities across ICSRs and aggregate reports. #halopv #pharmacovigilance #insife #automationsolutions
Presenting the AI Data Analyzer
We are diving into the aspirational use of technology for pharmacovigilance with a new project - working title "AI Data Analyzer". With our deep knowledge from PV processes and technology, the aim is to to implement rock solid methods for big data analytics in combination with artificial intelligence. Goal: to be able to do things better and more automated than ever before. Follow us if you are interested - we will be posting frequently on the progress.
#insife #halopv #artificialintelligence #bigdataanalytics
The biggest European based Pharmacovigilance technology
Just after celebrating our three year Birthday, we are also proud to add that we have grown to become the biggest European based Pharmacovigilance technology company around, measured on number of staff. Thanks everyone for trusting us to deliver consulting and technology - and we are looking forward to continue the collaboraion going forward!
New features for HALOPV 2.2.6
Take your management of the PSMF or other pharmacovigilance processes to the next level with HALOPV 2.2.6 that now features Office 365 Onedrive / Sharepoint integration. Synchronize files - for example when you need to involve integrate with existing libraries, or have multiple simultanous reviewers of a document in workflow. Pull in documents from Onedrive / Sharepoint and control them in HALOPV for pdf generation, merging, revisioning or other automation. #pharmacovigilance #office365 #halopv
Local PV submission requirements for Korea and China
Are you also struggling with the new South Korea requirements for ICSR R3 reporting? Or is China ICSR R3 reporting proving to be an issue in your organization? We have solved it by integrating HALOPV to the existing safety database. From there, your affiliates can be involved directly in the process - and your can even use built-in AI based translation engine to help moving information across global-local entities. . #halopv #insife #e2br3 #pharmacovigilance
New Vice President and Senior Management Team member
Praveen Gupta has joined Insife as Vice President and Senior Management Team member. With 20 years in the IT industry, he has helped top pharma clients in transforming their businesses for better operational efficiency by leveraging technological advancements such as Artificial Intelligence.
Insife has turned 3!
Insife is turning three ! We are proud to have made a significant contribution to the world of Pharmacovigilance already, in our first 36 months of existence. Across our HALOPV, Argus Safety SaaS and consulting offerings, we are now helping several top 10 pharma companies and a significant number of small and mid-size pharma companies too.
HALOPV - Pharmacovigilance made smarter
We're not just talking about it - HALOPV is making the life easier in drug safety (pharmacovigilance) departments, with reported time savings of up to 75%. Pharmacovigilance made smarter means less time on tedious, manual tasks, by more automation. And more time on data quality and decision-making. Learn why many pharma and biotech companies from big to small are choosing HALOPV on https://halopv.com #halopv #drugsafety #pharmacovigilance #automation #insife
Insife Webinar: Submission Management with HALOPV
Join our webinar on Submission Management with HALOPV. Learn how you can get rid of manual excel sheets when consolidating and reconciling the ICSR submissions from affiliates and partners. #HALOPV #pharmacovigilance
Sign up here: https://lnkd.in/gjmzKAs
HALOPV 2.2 released soon
It's only a couple of months away! HALOPV 2.2 (May release) will be a significant release on our roadmap and include:
- Simplified UI with fewer clicks, Widget-style front page components, Improved use of AI Translation and NLP
- Multiple export new formats: E2B(R2), E2B(R3), FDA Combination products, EU MIR
- API enhanced to include more data points and now prepared to run for both Argus Safety and ArisG.
Navigating in a Complex Global World
We have a 2-page article in the Greater Copenhagen Life Science Magazine that was just published today. It's all about how HALOPV can help life-science organizations manage their global Pharmacovigilance efforts with compliance and efficiency gains. Read the article here: https://lnkd.in/e2yEZys
#pharmacovigilance #insife #halopv #efficiency #compliance
ISO 9001:2015 certification
ISO 9001:2015 certification inspection was completed today at Insife's office in Copenhagen, we are now waiting for the official certificate to be issued. It has been a great journey to build a QMS from ground up and get it implemented / operationalized in our growing organization. We are proud to be focused on quality and doing things in the right way! #iso9001 #quality #qms
Automating EU MIR
The EU MIR has been mandatory since 01JAN 2020. We are now using HALOPV and it's powerful integration capability to deliver a solution. HALOPV allows you to take data from a safety database such as Argus Safety, add additional HALO integrators or forms to e.g. capture manufacturing and regulatory registration data, and to transform it into reports. Each task is automatically distributed to the stakeholders in the organization that are actually knowledgable about the specific data.
That's how we automate the generation of the EU MIR. The HALO way!