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Have you assessed your medical information system for compliance with GDPR regulation?
During a recent ArisGlobal webinar, “Practical Implementation of GDPR within Medical Information”, the audience answered a live poll. But, there’s still time to have your say. VOTE NOW:
Note: There is a poll embedded within this post, please visit the site to participate in this post's poll.
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Practical Implementation of GDPR with Medical Information
https://www2.arisglobal.com/on-demand-webinar-practical-implementation-gdpr-within-medical-information?Campaign_Code=18WCMI83&Web_source_=GDPR MA Webcast&source=Web Enquiry
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Practical Implementation of GDPR within Medical Information: A Post-Webcast Perspective
The General Data Privacy Regulation (GDPR) took effect May 25.2018 and its primary intent is to deliver greater data privacy protection to EU citizens, including protection for health-related data. To ensure that medical information professionals could assess their understanding of and level of compliance with this recently enacted regulation, ArisGlobal held a July 18th webcast, “Practical Implementation of GDPR within Medical Information.”
Since GDPR was first announced several years ago, ArisGlobal has been busy working with our user base, consultants, and internal and external auditors. We took their insight to arrive at our own interpretation of GDPR and then began working on how we could ensure that data privacy and data protection is by design, and what specifically our medical information management system, LifeSphere® MI, can do to support GDPR from the outset.
Support for GDPR involves having a combination of tools, technologies and processes in place. Gauging from the very strong interest, attendance, and questions asked by our webinar attendees, there is clearly still a level of concern and uncertainty from the medical affairs community as to their respective company’s level of understanding and compliance of this complex guideline.
Our hour-long webcast did not offer legal advice on the interpretation of GDPR, but rather focused on the practical implementation of GDPR within a medical information system, and specifically covered seven key areas:
- Data Encryption (encryption of data at rest
- Data Privacy Policy
- Viewing/Accessing Private Data from Different Countries
- Data Redaction
- Reporting
- Exclusions
- Inquiry Fulfillment
Our webinar presenter, Simon Sparkes, ArisGlobal Executive Vice President of Medical Affairs, kicked things off by posing the first polling question, “Have you assessed your medical information system for compliance with GDPR regulation?” so as to assess the audience’s current state of GDPR compliance readiness. Results indicated:
This took us somewhat by surprise as most of the companies ArisGlobal staff are in discussions with still largely fall either in the “no” (i.e., not yet started) or “in progress” stage.
Responses to our second polling question, “Have you accommodated GDPR in your current MI solution?” more closely aligned to our understanding of where things stand for most companies:
Based on all the topics covered, responses to the final polling question “Are you GDPR ready?” seemed in conflict to some extent with the responses to the second poll results:
Over two-thirds of the responding audience believe their company is “GDPR ready.” That is great news, but we can only surmise that if 57% haven’t assessed their MI solution for GDPR readiness, as shown in the responses to the first poll question, then the majority who are “GDPR ready” did not leverage their MI solution to assist in the effort. If that assumption is correct, that is unfortunate since an MI solution like LifeSphere MI, by its design, can provides the tools, technology and process in place to help ensure the ongoing proper consent to collect and share patient data, handle data retention, redaction and possible GDPR exclusions.
Lots of attendee questions pertaining to retention periods, pseudonymization, medical inquiries with associate adverse events, and more were answered before the webinar concluded. You can learn more by viewing the on-demand webcast at your convenience.
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A Month Following DIA 2018 Annual Meeting: How Transforming Life Sciences Productivity through Cognitive Platforms Is “Driving Insights to Action”
“Driving insights to action” was this year’s DIA Annual conference theme, and represented a perfect fit for where ArisGlobal LifeSphere® technology is innovating and evolving to strengthen and streamline product lifecycle management for good clinical practice and good regulatory practice. In two interconnected sessions, ArisGlobal’s subject matter experts presented “How Cognitive E2E Pharma Platforms Can Transform Productivity” in DIA’s Innovation Theatre. Vitthal Gouri, Head of Clinical Business Unit, and David Scanlon, Senior Director of Regulatory Strategy, showed how a cognitive, cross-domain platform enables an enterprise-level approach that transforms pharma with a process-driven approach that unifies every facet of the product lifecycle.
For those that couldn’t attend these sessions, this blog shares some of their collective insights.
Getting products to market faster and tackle rising trial design costs are long-standing priority issues for life sciences companies. These same companies are faced with equally long-standing barriers — multiple heterogeneous solutions deployed in disparate ways, poor data visibility, limited process and data intelligence, and relentless investments in legacy solutions.
Breaking Down the Barriers
Life Sciences companies are starting to work more collaboratively, and the need to break down these barriers has become acute. Today’s pharma companies are working with multiple external partners including CROs and vendors, academia, vendors, other life sciences businesses and regulatory authorities. At the same time, processes need to flow more seamlessly between different functions, including clinical, regulatory, and safety. For example, many activities in clinical overlap with regulatory activities, such as the management of key documents, issues related to patient safety, as well as data standards and governance.
While efforts have been made to improve the process of bringing a product to market through good manufacturing practice, good clinical practice, good pharmacovigilance practice and good regulatory practice, inconsistent approaches to how data is handled internally have led to each function developing its own standards and resulted in weak data governance.
One approach companies have considered to address the challenges they face is using web-based services with some integration enabled by middleware. The problem with this approach is it doesn’t deliver a single source of truth, and all too often companies end up with version incompatibility. The result is they can’t harmonize processes across the global enterprise.
Adopting a Unified Approach
Recognizing these challenges, there is a steady move by progressive companies toward a unified approach across the product lifecycle, leveraging a cognitive cloud platform. The fact is that drug development is now a clear E2E process that requires unification of systems, data, and processes and collaboration with external partners. Consider the processes from clinical development to new drug approval. Processes begin with the study proposal onto planning and setup, followed by site activity, then study conduct and finally study closure.
It’s also important to separate unification from integration. They are not the same and, in fact, integration may not be practical or necessarily ideal. After all, there are many stakeholders involved, making integration extremely difficult, as well as different functions needing their own systems and within each of those functions many different business processes. A cognitive cloud platform, on the other hand, makes it easier to share data and processes and ensure the right version is being worked on by each stakeholder without a massive technology overhaul.
There are further benefits to a cognitive cloud platform approach, including the ability to leverage industry best practices to achieve compliance and high quality, efficient and cost-effective upgrades thanks to multi-tenancy, and open architecture that allows easy integration with third-party solutions, meaning companies aren’t locked into a single solution.
Learn more about ArisGlobal’s LifeSphere Cognitive Cloud Platform, including LifeSphere Clinical and LifeSphere Regulatory.
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From Push to Pull – Making the Triage of Adverse Events Downloaded from EMA Hassle Free
There have been significant changes in the way the European Medicines Agency (EMA) expects marketing authorization holders (MAHs) to handle ICSRs from the new EudraVigilance system, creating additional work for already busy pharmacovigilance departments. In the past, the European Medicines Agency (EMA) would push Individual Case Safety Reports (ICSRs) via a gateway-to-gateway connection to the Manufacturer Authorization Holder (MAH)’s pharmacovigilance database. As part of the move towards simplified reporting, required as per the new EU pharmacovigilance legislation, the EMA is now putting more responsibility on MAHs by requiring them to log onto a common portal. Once logged into the EudraVigilance portal, MAHs must download ICSRs, review available files to identify relevant reports, and import those cases into their safety database.
This is an onerous task, made harder by the delivery of ICSRs in the E2B (R3) XML format. To determine relevance, the pharmacovigilance staff must manually review each ICSR. During this review the pool of available ICSRs are categorized into applicable cases and non-relevant cases. The usage of the E2B (R3) XML format means that ICSRs are not easily readable in their raw structure. The overall process is resource-intensive and inefficient.
Understanding the Challenges
During a recent ArisGlobal webcast, “From Push and Pull with EMA: A Modern Take on Triaging Adverse Events, we asked attendees, “What is your greatest challenge when it comes to triaging reports?” Responses were split evenly between handling the high volume of adverse events and time spent downloading files (both 37%). Other concerns were the reconciliation of applicable files and the manual segregation of files were considered priority concerns by fewer respondents (15% and 11% respectively). High volumes and time spent on activities go to the heart of the overarching issue companies face – that of managing a huge and growing workload with fewer resources.
But what if there is a better way to handle the triage and reconciliation of the ICSRs downloaded from EudraVigilance? ArisGlobal has developed a tool called LifeSphere® EV Triage (EudraVigilance triage tool), that automates the manual process of reviewing, triaging and reconciling the downloaded ICSRs. The tool uses an algorithm to filter-out relevant ICSRs from the available files. The algorithm uses the key parameters generally used by pharmacovigilance staff for review. The data elements include local trade name, active substance/active ingredient names, form of administration, route of administration and primary source country. These data points are referenced in the MAHs product dictionary and compared to the data within the ICSR files. The tool, therefore, can address both volume and time constraints associated with this activity.
The tool also provides an option to reconcile and archive downloaded cases. For cases that are determined to be not relevant, the tool archives them for future reference. This local repository eliminates the dependency of the MAH on the EudraVigilance portal to locate and retrieve cases that were initially determined to be non-relevant.
The LifeSphere® EV Triage tool incorporates most advanced automation and artificial intelligence (AI) technologies and is expected to substantially decrease the manual effort involved in ICSR download and triage. The smart analysis and auto-matching features ensure that relevant cases are identified and categorized appropriately. The natural language processing (NLP), employed for narrative analysis in this tool, is a self-learning technology that gets better at determining relevance, as more information on products is available to the safety system.
Addressing Automation Reservations
Any discussion about AI and automation, however, needs to account for industry reticence and uncertainty about the technology. So, in our webcast, we asked attendees, “What is the biggest hindrance in adopting automation technologies?” Perhaps not surprisingly, uncertainty over quality was considered the biggest barrier (48%) followed closely by cost of integrating existing systems (45%). Very few considered perceived ROI not justifying the investment or scarcity of skills major obstacles (4% in both cases). With the most advanced and proven automation technologies incorporated in LS EV triage tool, the performance of this tool is expected to be high. As per the feedback received by our early adopters, the tool has provided efficiency gains of up to 80%.
As there is no definite timeline communicated by EMA on resuming the gateway-to-gateway transmission of ICSRs, using a tool that automates the review and triaging process of ICSRs downloaded from EudraVigilance will relieve MAHs from the current burden of a manual process. Even when the direct transmission is resumed, MAHs would do well to streamline the triaging process so they have complete control over their safety cases.
We invite you to learn more on this topic by viewing our on-demand webcast From Push and Pull with EMA: A Modern Take on Triaging Adverse Events.
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Dohmen Life Science Services (DLSS) Selects ArisGlobal’s LifeSphere® Safety MultiVigilance Multi-Tenant Cloud Platform, Adding Cognitive Computing to Best-in-Class Medical Communication, PV & Commercial Services
Miami, FL. August 14, 2018 – ArisGlobal, a leading life sciences technology provider, announced that Dohmen Life Science Services (DLSS), a leading provider of outsourced commercialization services within the life sciences industry, selected LifeSphere Safety MultiVigilance as an additional pharmacovigilance platform to manage case processing for its global clientele of pharma and medical device companies.
LifeSphere Safety MultiVigilance leverages the LifeSphere® platform, which uses state-of-the-art robotic and cognitive computing technologies like natural language processing (NLP) and machine learning to enable automation. The solution has the potential to transform the practice of pharmacovigilance from a tedious, resource intensive process to a dynamic and efficient practice. Over the past year, ArisGlobal’s highly skilled team of pharmacovigilance and cognitive computing experts have been actively involved in developing the next-generation, automation-enabled technology that is revolutionizing the way pharmacovigilance case processing is done today.
“As our global business rapidly expands and the regulatory environment becomes more complex, we recognize the value that cognitive automation brings to the traditionally manual pharmacovigilance process,” shares Herb Lee, Senior Vice President, Medical Communications & PV, DLSS. “The LifeSphere Platforms gives our clients access to a complete PV service solution powered by our experienced PV staff, backed by the added efficiency of automation and data analysis. “Every investment we make is designed to help our clients improve operational efficiency, capture revenue faster, maintain compliance, and most importantly, best serve the needs of their patients,” added Lee.
The platform features a pre-configured, tested and ready-to-use application, provided and hosted for DLSS. Interactive data monitoring and analysis capabilities across multiple tenants helps DLSS provide its clients with critical insights to track daily operations and make informed strategic long-term decisions.
“ArisGlobal’s LifeSphere Safety MultiVigilance multi-tenant cloud solution provides robust security, scalability, seamless upgrades and cutting edge cognitive computing technology leading to better compliance to global regulations and cost-effective pharmacovigilance processes,” said Sankesh Abbhi, President and CEO, ArisGlobal.
Learn more: LifeSphere Safety MultiVigilance
About ArisGlobal
ArisGlobal is a visionary technology company that’s transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. The ArisGlobal LifeSphere® cognitive technology platform integrates machine-learning capabilities to automate the core functions of the product lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, our cognitive platform delivers actionable insights, boosts efficiency, ensures compliance, and lowers total cost of ownership through multi-tenancy.
Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. Visit arisglobal.com, or follow ArisGlobal on LinkedIn and Twitter.
About Dohmen Life Science Services:
Now part of a growing life sciences services platform owned by Water Street Healthcare Partners and JLL Partners, DLSS provides biopharma and medical device companies with a wide array of outsourced services for patient support, channel distribution, regulatory strategy, compliance and finance. The portfolio of solutions is designed to simplify commercialization, optimize market access and build share for new and existing therapies. Visit dlss.com to learn more.
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The Silent Hero: How Advances in Today’s Technology Can Prevent, Assess, Detect, Treat and Predict Health Issues
Vaccines are required to have a higher level of safety compared to other drugs, as these are administered to healthy individuals. In several countries it is becoming mandatory for children to be vaccinated according to their national immunization schedules in mass vaccination campaigns.
In a recent report from China’s regulator (CFDA), about 250,000 defective rabies vaccine doses were administered to children in China. There were serious questions raised on the manufacturing standards for these vaccines. Although there are currently no reports of adverse events linked to these vaccines, the vaccines produced through sub-standard manufacturing processes have a potential to cause major adverse events. Additionally, these vaccines may fail to protect the vaccinated person from targeted infection. This may result in a major public health disaster.
Most often than not, significant quality issues are identified after several doses of defective medicinal products, such as vaccines, have been administered. Advances in technology can play a significant role in preventing major public health hazards due to faulty vaccines and other medicinal products. Digital biosurveillance methods can be used for adverse event surveillance post vaccination. These methods combined with advanced cognitive computing technologies like natural language processing, can quickly assess internet for any content that is related to specific health events.
Advanced Technology to the Rescue
Advanced computing methods can be used for safety monitoring and early detection of potential signals of vaccine-related adverse events. These methods work by mining open-access active-moiety databases and vast scientific literature with clinical case studies. The algorithms then construct a relationship between a medicinal product, a biological target protein and an adverse event. Any possible relationships identified through these methods can be used as a working hypothesis for conducting further assessments.
Cognitive computing technologies have already demonstrated their value in healthcare industry and are making inroads into several specialized areas. Several intelligent applications are being developed that proactively check on a patient’s symptoms, provide recommendations on management of symptoms, disease management and treatment. The real-time data generated from these applications can be used by machine learning algorithms for predicting the occurrence of intended or unintended effects of medicinal products and can prompt early action.
ArisGlobal’s LifeSphere® Safety solutions have been built with the state-of-the-art technologies that efficiently and intelligently capture safety data, automate case processing and allow early detection of safety signals. In addition to regulatory compliance, the system has advanced capabilities that help manufacturers carry out end-to-end pharmacovigilance tasks, so that medicinal-product related safety risks are identified early and risk mitigation activities can be initiated.
You can learn more by viewing the whitepaper on “The Role of Technology in Vaccine Pharmacovigilance.”
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“Precision Pharmacovigilance: Is This the Way Forward?” to be Presented by ArisGlobal Safety Expert at World Drug Safety Congress Europe
MIAMI, FL. AUGUST 13, 2018 –ArisGlobal, LLC, a leading provider of integrated cloud-based software solutions for life sciences, will present a session titled “Precision Pharmacovigilance: Is this the Way Forward?” at the upcoming World Drug Safety Congress Europe conference to be held in Amsterdam from September 10-11, 2018.
Dr. Vivek Ahuja, Vice President, Global Pharmacovigilance, ArisGlobal, will present the session, scheduled for September 10, 13:55-14:15 a.m., as part of the “Big Data & AI in Safety” track. As the sources of personal health data are increasing, and with big data coming from heterogeneous and complementing sources, Dr. Ahuja will discuss how there is now a distinct opportunity to understand the safety of drugs at a more granular level.
“Cutting edge technological advances in computing ability have empowered us to perform breakthrough research and analysis in the area of pharmacovigilance. ‘Big data’ of patients assimilated from various sources can be now stratified and segmented according to population demographics. We are now much closer to solving the mystery of how a deep understanding of this data can actually be used to prevent adverse events, thus attaining the real purpose of pharmacovigilance.“
ArisGlobal is a Silver Sponsor of the conference and an exhibitor and will be showcasing LifeSphere Safety, its cognitive computing platform, in Booth #7. Attendees are invited to meet with ArisGlobal staff to learn about its innovative and leading pharmacovigilance and safety platform.
About ArisGlobal
ArisGlobal is a visionary technology company that’s transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. The ArisGlobal LifeSphere® cognitive technology platform integrates machine-learning capabilities to automate the core functions of the product lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, our cognitive platform delivers actionable insights, boosts efficiency, ensures compliance, and lowers total cost of ownership through multi-tenancy.
Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. For more information, visit arisglobal.com or follow ArisGlobal on LinkedIn and Twitter.
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ArisGlobal Safety Expert to Present “The IoT of Pharmacovigilance: From Concept to Reality with Digital Technologies” at 5th Annual Risk Management and Pharmacovigilance Summit
MIAMI, FL. SEPTEMBER 7, 2018 – ArisGlobal, LLC, a leading provider of integrated cloud-based software solutions for life sciences, will present a session titled, “The IoT of Pharmacovigilance: From Concept to Reality with Digital Technologies” at the upcoming 5th Annual Risk Management and Pharmacovigilance Summit to be held in Vienna from September 18-20, 2018.
Dr. Vivek Ahuja, Vice President, Global Pharmacovigilance, ArisGlobal, and an industry thought leader, will present the session, scheduled for September 19, 11:55 a.m. He will explore the scope of IoT technologies and allied technologies in pharmacovigilance, and share the expected impact this will have in the drug safety world.
“Simply put, IoT is a network of devices with embedded sensors capable of machine-to-machine communication,” Dr. Ahuja explained. “Together with advanced computing technologies like artificial intelligence in pharmacovigilance systems and processes, the world of drug safety as we currently know it, is facing digital disruption that will create major transformation for the better. The barriers between passive and active pharmacovigilance can be dissolved and communication among all stakeholders including patients, healthcare providers, marketing authorization holders, and regulators can be enhanced.”
About ArisGlobal
ArisGlobal is a visionary technology company that’s transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. The ArisGlobal LifeSphere® cognitive technology platform integrates machine-learning capabilities to automate the core functions of the product lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, our cognitive platform delivers actionable insights, boosts efficiency, ensures compliance, and lowers total cost of ownership through multi-tenancy.
Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. For more information, visit arisglobal.com or follow ArisGlobal on LinkedIn and Twitter.
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Automated Segregation of Relevant ICSRs from EudraVigilance
One of the key requirements of the new pharmacovigilance legislation (Regulation 726/2004) in the EU is simplified reporting of individual case safety reports (ICSRs) by a Marketing Authorization Holder (MAH) to the new EudraVigilance (EV) system
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Beat the Clock with Future-Ready ICH E2B (R3) Compliant Safety Database Systems for Chinese Submissions
In 1998, China joined the WHO’s International Drug Monitoring program and started strengthening adverse drug reaction (ADR) surveillance by establishing a comprehensive pharmacovigilance system, including a legal framework, monitoring systems, IT infrastructure, investments, and controls. About 19 years after joining WHO, China officially joined ICH in 2017 as its eighth regulatory member. This is a major step forward for China in achieving global harmonization for providing safe, effective and high-quality medicinal products to its population.
Going further in this path of global harmonization, China adopted several ICH guidelines for safety including ICH E2A (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting), ICH E2D (Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting), ICH M1 (MedDRA Medical Dictionary for Regulatory Activities), and ICH E2B (R3) (Electronic Transmission of Individual Case Safety Reports).
The ICH E2B (R3) guideline adopted by China delineates the requirements for electronic transmission of individual case safety reports (ICSRs) and provides specifications on data elements for reporting adverse events during clinical trials and the post-authorization period. The data structure is based on globally accepted Health Level 7 (HL7[i]) standards, and the XML schema for ICSRs increases portability.
The drug regulatory authority of China, the National Medical Product Administration (NMPA, formerly CFDA) has set aggressive timelines for drug manufacturers to comply with electronic standards for safety report submissions.
For drug manufacturers, it is mandatory to submit SUSARs in ICH E2B (R3) format from 01 May 2019. Until this time, the reports can be submitted in ICH E2B (R2) format. The SUSAR reports will be accepted by Center of Drug Evaluation (CDE), the subsidiary of NMPA that is responsible for clinical trial regulation.
For ADRs of marketed products, Center of ADR Monitoring (a subsidiary NMPA) will start accepting cases in ICH E2B (R3) format from 01 Jul 2019. Commencing 01 Jul 2022, it will be mandatory for drug manufacturers to submit all post-marketing ADRs in ICH E2B (R3) format.
In order to stay compliant with these requirements, drug manufacturers are required to procure an electronic safety database that is compliant with ICH E2B (R3) format and is capable of generating safety reports as per NMPA requirements. For drug manufacturers who have a local safety officer (LSO) in China and already have a safety database, adverse event reports can be directly submitted to CDE/Center for ADR monitoring databases through an electronic database-to-database transmission. If a drug manufacturer does not have an LSO in China, safety reports can be submitted through one of the several ArisGlobal partner CROs who have a regulatory-compliant electronic safety database system.
ArisGlobal’s LifeSphere Safety MultiVigilance (formerly ARISg/ARISc) is a single global database system that supports all safety reporting requirements and is fully compliant with Chinese safety reporting requirements, including the ICH E2B (R3) data format. Therefore, the existing LifeSphere Safety MultiVigilance users on the latest version of application are already compliant with these requirements and can transmit cases in ICH E2B (R2) or E2B (R3) formats to NMPA.
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ArisGlobal Launches LifeSphere® MultiVigilance (LSMV) Platform Powered with Cognitive Computing
Leading companies and regulatory agencies adopt LifeSphere Intake and Triage, the principal application of LSMV suite
MIAMI, FL. October 3, 2018 – ArisGlobal, a leading life sciences technology provider, announced the launch of LifeSphere MultiVigilance – the next-generation platform for individual case safety report (ICSR) intake powered by LifeSphere Nava – ArisGlobal’s cognitive computing engine. LifeSphere MultiVigilance is developed on a completely new, cutting-edge technology architecture designed for the cloud with the latest robotic automation and cognitive computing technologies including natural language processing (NLP) and machine learning to transform all pharmacovigilance (PV) activities.
LifeSphere MultiVigilance is also the first and only unified platform fully integrated with product quality complaints and medical information management, delivering a new dimension on compliance with seamless exchange of safety cases between these critical functions.
ArisGlobal has been partnering with leading pharmaceutical companies and regulatory agencies to develop the new platform. Together, ArisGlobal and its strategic partners focused on identifying business critical problems within safety case processing, and then identified innovative ways to solve these problems. Each of the PV platform’s automation functions were extensively tested during the development process by ArisGlobal’s PV and IT experts, with additional PV expertise provided by its partners.
LifeSphere Intake and Triage will transform into a fully functional safety system by Q3 2019, which Boehringer Ingelheim, one of ArisGlobal’s strategic automation partners, will implement. The new PV platform will replace legacy ARISg, and migration of its multi-tenant customer base to the new platform will occur over the next 12-18 months.
“LifeSphere MultiVigilance is the only production ready, cognitive computing enabled, case intake platform available today that can integrate with any type of safety system. This platform not only simplifies safety case processing but also leads to significant cost savings for all marketing authorization holders. We believe this platform is a game-changer for the industry, as our customers will achieve cost savings greater than 30% with higher data quality and compliance,” said Sankesh Abbhi, President and CEO, ArisGlobal. “No other platform can deliver this type of performance.”
Boehringer Ingelheim has been working closely with ArisGlobal on LifeSphere MultiVigilance. “We are extremely excited and optimistic about the quality and productivity gains that this technology will provide,” said Claudia Lehmann, Head of PV Operations, Boehringer Ingelheim. “We have seen how the platform’s advanced robotic automation and cognitive features will allow us to automate many of our key PV steps in the area of case processing, which are currently resource intensive.”
Additional Information
For more on LifeSphere Intake and Triage: https://www.arisglobal.com/products/lifesphere-intake-and-triage/.
About ArisGlobal
ArisGlobal is a visionary technology company that’s transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. The ArisGlobal LifeSphere® cognitive technology platform integrates machine-learning capabilities to automate the core functions of the product lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, our cognitive platform delivers actionable insights, boosts efficiency, ensures compliance, and lowers total cost of ownership through multi-tenancy.
Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. For more information, visit arisglobal.com or follow ArisGlobal on LinkedIn and Twitter.
The post ArisGlobal Launches LifeSphere® MultiVigilance (LSMV) Platform Powered with Cognitive Computing appeared first on ArisGlobal.
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Chinese Pharmacovigilance Landscape – A Shift from Manual to Electronic Systems
One of the key requirements of the new pharmacovigilance legislation (Regulation 726/2004) in the EU is simplified reporting of individual case safety reports (ICSRs) by a Marketing Authorization Holder (MAH) to the new EudraVigilance (EV) system
[contact-form-7]
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Chinese Pharmacovigilance: How Auto-Translation and Side-by-Side Dual Language Panels Can Reduce Your Manual Effort
Pharmacovigilance (PV) is going truly global, as most regulatory authorities across the world are making it mandatory to submit adverse event reports of international cases. Similarly, for manufacturers in China, there is a regulatory requirement of reporting any adverse event case received from outside China. For compliance with this requirement, the individual case safety reports (ICSRs) are required to be translated into Chinese before they are submitted to the National Medical Product Administration (NMPA, formerly CFDA).
Translation of safety reports is a complex challenge, as the safety information has to be captured precisely without any margin for discrepancies. There are multiple factors involved in the precise translation of reports such as understanding the local colloquialisms, abbreviations, and source documents. Specifically, safety narrative writing can be an extremely challenging task as narratives within individual case safety reports (ICSRs) are required to provide a complete medical story, particularly for serious cases and expedited reports with multiple sources of information. Auto-narrative generation tools can decrease the manual effort in preparing the narratives from scratch.
Translating the safety narratives manually is an equally tedious process as it requires a high degree of accuracy with the original narrative. ArisGlobal’s LifeSphere Safety MultiVigilance (LSSMV) database system has auto-translation capabilities that can translate narratives from English to Chinese and vice versa. The application uses an advanced machine-translation technology, which supports pharmacovigilance staff in efficient translation of narratives. Given the focus of this blog on Chinese PV, LSMV incorporates features for effectively capturing colloquialisms in Chinese, among other advanced features. These ensure higher consistency and accuracy of the translation.
LSMV provides multi-lingual support, therefore within a single database system PV staff can enter cases in different languages including medical coding using Chinese MedDRA. For instance, a drug-related adverse event reported in the US has to be reported to USFDA, however, if the drug in question is also approved in China, the report is also required to be submitted to NMPA in Chinese. LifeSphere Safety MultiVigilance supports entry of narratives both in English and Chinese within the same database system. Further, there is an option for side-by-side dual language panel display. This allows review and quality check of the translated case report with significantly less effort and also ensures a very low error rate.
Automated translation of narratives functionality in LifeSphere MultiVigilance is an auditable feature. Further, in the side-by-side dual language panel display feature, the data entered in both panels are audited and an audit trail can be generated. These audit trails will serve as an important source for manufacturers to demonstrate compliance with quality processes during inspections.
For more information, view our recent webcast ICH Regulation and Compliance in China: Get Ready for Tomorrow.
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Clinical Expert to Present “Artificial Intelligence in Clinical Trials Automation” at Partnerships in Clinical Trials Europe
MIAMI, FLORIDA. October 25, 2018 — ArisGlobal, a leading provider of integrated, cloud-based software solutions for life sciences, announced that Vitthal Gouri, Associate Vice President, Clinical Solutions at ArisGlobal, will present “Artificial Intelligence in Clinical Trials Automation” at Partnerships in Clinical Trials Europe, scheduled for November 27-29, 2018 in Barcelona, Spain.
The half-hour session, scheduled for November 29th, 10:00 a.m. will explore the number of different ways that today’s cutting-edge technologies can be leveraged to dramatically improve clinical trials through automation.
“As the cost of drug development and time to market continues to increase, it’s time to look beyond traditional technical solutions and embrace how artificial intelligence and machine learning can significantly improve quality, resource efficiency, and overall time in bringing products and devices to market,” says Vitthal. “Recent research suggests that these advanced technologies can significantly reduce the time, and cut the cost by more than half.”
Vitthal leads the LifeSphere® Clinical business unit, ArisGlobal’s multi-tenant cloud-based eClinical platform for clinical operations and clinical data management that leverages industry standard practices and cognitive computing to efficiently automate core business processes.
Learn more: LifeSphere Clinical – Streamlining eClinical with a Unified Platform
About ArisGlobal
ArisGlobal is a visionary technology company that’s transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. The ArisGlobal LifeSphere® cognitive technology platform integrates machine-learning capabilities to automate the core functions of the product lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, our cognitive platform delivers actionable insights, boosts efficiency, ensures compliance, and lowers total cost of ownership through multi-tenancy.
Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. For more information, visit arisglobal.com or follow ArisGlobal on LinkedIn and Twitter.
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Advertorial: The Role of Artificial Intelligence within Pharmacovigilance and Medical Information
There are a myriad potential uses of AI for Medical Information and pharmcovigilance, and if you don’t have an AI strategy you will be left behind. AI will allow us to automate.....
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FDA Selects ArisGlobal Next-Generation Safety Platform to Implement New Integrated Safety Platform
FDA Selects LifeSphere MultiVigilance, Medical Information, and Product Complaints as Components of Their New Integrated Safety Platform
MIAMI, FL. November 27, 2018 – The U.S. Food and Drug Administration (FDA) has selected Booz Allen Hamilton to support development, modernization, and enhancement of the FDA Adverse Event Reporting System (FAERS). As part of this work, the Agency will deploy ArisGlobal’s LifeSphere MultiVigilance (LSMV) platform to replace part of its current pharmacovigilance system that will intake, triage and process safety reports and make them available for review and analysis. LSMV will deliver the assured compliance, configurability, and flexibility needed to meet its growing responsibilities for protecting public health and safety. ArisGlobal’s LifeSphere Product Complaints and Medical Information will provide end-to-end processing of product quality defect reports, as well as tracking and responding efficiently to inquiries.
LSMV is the next-generation safety system from ArisGlobal. It combines artificial intelligence (AI) with robotic process automation (RPA) to help organizations streamline case processing and medical review, substantially reducing manual effort. This new platform will be transformative for FDA in its ability to automate process, incorporate latest safety data standards and improve productivity resulting in reviewers to focus on public health and patient safety.
“Booz Allen is proud to support the FDA’s mission to protect public health by strengthening the Agency’s pre- and post-market surveillance operations. Our multidisciplinary team of drug safety domain experts and technologists will be responsible for providing the FDA an integrated and modernized suite of capabilities to protect consumers from unsafe and/or ineffective products.,” said Sean Chaffee, Booz Allen Hamilton FAERS Program Lead. “This transformational work will fundamentally improve health outcomes and positively impact mission performance.”
“We are delighted that our recently launched unified platform for drug safety, medical information and product quality complaints has been selected by FDA.” said Sankesh Abbhi, President and CEO, ArisGlobal. “Complementing the platform, our Regulatory Authority Standard Practices (RASP) initiative allows us to fully understand the needs and expectations of the regulatory health authorities. With the addition of the FDA, nine major authorities now rely on ArisGlobal solutions to protect public health.”
Learn more: LifeSphere MultiVigilance
Learn more: LifeSphere MI
Learn more: LifeSphere Product Complaints
About ArisGlobal
ArisGlobal is a visionary technology company that’s transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. The ArisGlobal LifeSphere® cognitive technology platform integrates machine-learning capabilities to automate the core functions of the product lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, our cognitive platform delivers actionable insights, boosts efficiency, ensures compliance, and lowers total cost of ownership through multi-tenancy.
Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. For more information, visit arisglobal.com or follow ArisGlobal on LinkedIn and Twitter.
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ArisGlobal Safety Experts to Present at 9th Asia Pharma R&D Leaders
MIAMI, FL. JANUARY 3, 2019 – ArisGlobal, LLC, a leading provider of integrated cloud-based software solutions for life sciences, will present a session titled, “ArisGlobal Solution: Supporting Life Science Industry to Be Compliant with the New Regulation in China” at the upcoming 9th Asia Pharma R&D Leaders – Pharma & Healthcare to be held in Beijing from January 21-22, 2019.
Krishana Gopal Das, Head of Product Strategy, and Ye Zha, Executive Director, Greater China, ArisGlobal, will present the session, scheduled for January 21, 4:00 PM CST. Krishana and Ye will provide an overview of pharmacovigilance in China and the recent regulatory reforms made to achieve standards on par with leading health authorities.
“With the recent string of regulatory reforms and NMPA joining ICH, China is poised to catch up with the leading health authorities in bringing high-quality, low-cost, innovative solutions to its population and ensuring safe and effective use of medicinal products,” Krishana explained. “In addition to sharing an overview of pharmacovigilance in China, we will also share how drug manufacturers can comply with the new regulatory environment for drug safety in China using modern applications.”
ArisGlobal is a sponsor of this conference and will be exhibiting in booth #14. Attendees are welcome to visit and learn more about LifeSphere® MultiVigilance, the next-generation platform for individual case safety report (ICSR) intake powered by LifeSphere Nava – ArisGlobal’s cognitive computing engine.
About ArisGlobal
ArisGlobal is a visionary technology company that’s transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. The ArisGlobal LifeSphere® cognitive technology platform integrates machine-learning capabilities to automate the core functions of the product lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, our cognitive platform delivers actionable insights, boosts efficiency, ensures compliance, and lowers total cost of ownership through multi-tenancy.
Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan and China. For more information, visit arisglobal.com or follow ArisGlobal on LinkedIn and Twitter.
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Fosun Pharma Selects ArisGlobal’s LifeSphere® Safety MultiVigilance Solution Suite to Supports Its Global Pharmacovigilance Strategy
Selection made based on a new partnership with ArisGlobal and
Epharma Healthcare Technology
Miami, Florida – January 10, 2019 – ArisGlobal, a leading life sciences technology provider, announced that China-based Fosun Pharma has selected LifeSphere Safety MultiVigilance (LSMV) as its global pharmacovigilance system. Fosun will utilize ArisGlobal’s technology to achieve full E2B (R3) compliance with greater efficiency and compliance. The selection was made in conjunction with ArisGlobal partner Epharma Healthcare Technology Co., Ltd, a one-stop solution provider for the pharmaceutical research and development industry.
Fosun Pharma and Epharma join a growing list of biopharmaceutical companies and health authorities making the decision to replace current pharmacovigilance systems with ArisGlobal’s LSMV solution suite. Epharma is an official retail partner for ArisGlobal and will help the company promote the product in the Chinese region. LifeSphere Safety MultiVigilance is currently used by more than 200 life sciences companies, including 9 health authorities.
“Advanced technology, such as artificial intelligence and machine learning, are key LSMV capabilities that help us automate repetitive, manual tasks, thus improving efficiency and compliance,” said Fosun Pharma. By switching to LifeSphere Safety MultiVigilance, our efforts to comply with regulations will be much more efficient.”
“ArisGlobal offers the most innovative safety, clinical, regulatory, and medical affairs solutions in the Chinese market,” said Sankesh Abbhi, President and CEO, ArisGlobal. “Fosun Pharma is just one example how our customers in China can efficiently and inexpensively meet a wide range of requirements for regulatory compliance and patient safety.”
Additional Information
For more on LifeSphere Safety MultiVigilance: https://goo.gl/KNMaVF
About ArisGlobal
ArisGlobal is a visionary technology company that’s transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. The ArisGlobal LifeSphere® cognitive technology platform integrates machine-learning capabilities to automate the core functions of the product lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, our cognitive platform delivers actionable insights, boosts efficiency, ensures compliance, and lowers total cost of ownership through multi-tenancy.
Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan and China. Visit arisglobal.com, or follow ArisGlobal on LinkedIn and Twitter.
About Fosun Pharma
Fosun Pharma is a leading healthcare group in China established in 1994 and is a A+H listed company, covering key sectors of healthcare industry chain. Fosun Pharma currently got 28,848 employees globally supplied 100 million injectable artesunate to international markets and estimated to have cured more than 20 million patients with severe malaria. Fosun Pharma is ranked among the top 5 domestic pharmaceutical companies in China.
About Epharma Healthcare Technology Co., Ltd
Epharma is committed to the promotion of informatization in Chinese pharmaceutical R&D industry through advanced cloud platform technology to provide a series of solutions for the development from research & clinical to industrialization. At present, there are 30 team members responsible for this business. Before the end of 2019, it will integrate the world’s top pharmaceutical research and development system platform, build a comprehensive data management platform, and the team would have more than 250 employees.
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