Case Study: Global Reporting Rule and Audit Capture Engine (GRRACE) solution
Global Reporting Rule and Audit Capture Engine (GRRACE) solution automated the process of creating new reporting rules or modifying existing ones in Argus Safety at a top tier Pharmaceutical Company
Overview
Nextrove has been supporting one of the world’s premier biopharmaceutical companies to automate, simplify and optimize the end-to-end development of Argus Safety reporting. Nextrove’s GRRACE (Global Reporting Rule and Audit Capture Engine) application has been leverage for the project.
The Goal
Creation and maintenance of Argus Safety reporting rules to auto-schedule reports for submissions to multiple destinations includes several steps and multiple stakeholders:
Reporting rules are a critical component of Argus Safety configuration to ensure compliance with regulations. Each step requires approval by respective stakeholders and extensive QC. Additionally, the cycle re-start to incorporate in reporting rule any new regulatory change including tracking of the relevant maintenance activities to demonstrate compliance with the effective date of regulations.
The manual end-to end process includes a series of hand-offs, paper-based configuration design, archive maintenance to document the entire cycle from requirements to testing, from QCs to approvals and to deployment.
Objective of project was to automate the entire end-to-end process, to track all actions, to keep records of approvals, to support inspections readiness via an application audit-ready, and to maintain and monitor metrics.
The Approach
Nextrove GRRACE application includes a workflow with various steps, and it is audit ready.
The process starts with entry of regulatory requirements by the business department(s). Upon approval, the second step includes the automatic transposition of requirements,
based on defined and configured rules, into a screen mimicking the fields of Argus console. An Advance Condition (AC) Library is available to select the appropriate AC. Following approval of the reporting rule design, the reporting rules script designer supports the preparation of test scripts. Upon approval of test script, testing is performed, and results embedded and archived in the application. Deployment in Argus Safety and in multiple environments happens automatically and Argus Safety console is automatically populated, following approval of test results.
The Benefits
Nextrove GRRACE automates the process of creating new reporting rules or modifying existing reporting rules in Argus Safety.
Nextrove GRRACE provides one single repository for activities, approvals and documentation supporting the creation of reporting rules and increases efficiencies by eliminating manual hand-offs.
Additionally, by automating key stages from requirement to deployment, it significantly reduces operational costs and time.
From a quality perspective, Nextrove GRRACE ensures transparency for end-to-end process and facilitates inspection readiness by incorporating the audit trail and providing a dashboard to generate reports and collect metrics.
Client Testimonials
Nextrove Team showed consistency, passion and Knowledge and contributed at the highest level for the go-live accomplishment. They are all resources I would like to work with in upcoming activities
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Case Study: Progressive Global Follow-up Automation (GFA) solution
Progressive Global Follow-up Automation (GFA) solution transformed the entire follow-up process at a top tier Pharmaceutical Company
Overview
The role of pharmacovigilance is monitoring safety of marketed drugs and investigational products to support and ensure patient safety. When first received, adverse event information is often incomplete. These reports should be followed-up as necessary to obtain supplementary detailed information significant for the scientific evaluation of the cases. Client followed a manual process for generating follow-up letters and questionnaires with specific event/product pair questions.
This process is labor-intensive, with a suboptimal rate of response from reporters and includes a high cost for mailing. Lack of a user-friendly mechanism to provide responses by the reporters required additional manual intervention by the Client teams.
Increasing number of new sources of information need to be managed like social media, patient support programs or customer engagement programs.
The budget allocated to case processing is a large amount of the total pharmacovigilance budget and is growing due to increasing case volume.
Solution
Nextrove collaborated with the Client and launched a project to optimize and automate the follow-up data collection process by leveraging Progressive GFA. GFA application enables business users to streamline the process by auto-identifying missing data in a case, then generating custom configured letters and questionnaires for product/event pairs including only the specified missing data, accompanied with a cover letter.
Deployed 440 letters and questionnaires in 38 languages.
Nextrove configured Progressive GFA to generate follow-up letters and questionnaires with pre-defined data fields and to identify the supplementary data to be requested for the case according to Client policies and business process.
GFA enabled the capability to enter reporter’s responses, when provided via phone, directly in the application and to ingest the relevant form automatically as source document in the safety database.
Following Client operational procedures, action items management was automated (e.g. closure of follow-up letter action items, and management of reminders).
GFA is audit and inspection ready. All activities performed through this application, are tracked allowing follow-up monitoring and relevant metrics generation.
Results
Client Testimonial
“Thank you Nextrove team for the tremendous efforts, dedication, and hard work in implementing this innovative and complex project with finesse and great success. It stands as a testimony to the Nextrove team's extraordinary skills and expertise. Kudos to you all! “
Perspective: GFA Return on Investment
Greater than 150% ROI, ROI grows with growing case volume.
Assumptions: 1. Follow-up data collection is done via email for 80% of the 3000-case volume per year 2. Postal communication scenarios are excluded and not applicable 3. Industry averages (on the conservative side) have been used for the calculation.
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NEXTCLOUD, Nextrove cloud-based solution for pharmacovigilance
Cloud-based solutions for pharmacovigilance include the delivery of online services such as servers, databases, storage software, analytics and intelligence to users.
Nextrove provides Argus Safety hosting along with other integrated applications like Cognos, BO, BIP, Axway and other custom solutions as per client needs. Our cloud,is a flexible and secure environment and provides a worry-free white glove service to our customers to run and manage their safety database systems.
Nextrove Cloud Advantages
In comparison to on-prem hosting, Nextrove cloud provides various advantages as listed below:
Scalability: flexibility to utilize automatic monitoring and scaling of volumes and workload and respond quickly to peak demand instead of purchasing and installing additional equipment on-premises.
Data storage: services of data storage eliminating the need to buy and manage on premise proprietary data storage infrastructure.
Business Continuity and Disaster Recovery: formal procedures for business continuity and disaster recovery, built-in back-up, and recovery to eliminate the risk of data loss.
Current and Compliant: software and applications upgrade as new functionalities become available and following latest industry standards. Safety applications advancements as soon as new regulatory requirements are announced to support compliance with regulations.
Security and data access: security and data access eliminating the burden of maintaining on premise network, infrastructure and firewalls. Access to internal or external individuals, and/or collaborators and/or other organizations. Nextrove owns the information security for hosted solutions.
Automation and Artificial Intelligence: digitalization of business processes through automation using proprietary Progressive platform, multi-lingual operations, and proprietary APIs for system integration. Seamless move of the information in and out of the application. Can integrate combination of tools simplifying how data is inserted, imported, exported, extracted from the application.
Cost saving: cost reduction by eliminating the need of expanding existing on-site server capability, the need of upgrading as new regulatory requirements or new application functionalities become available. Decrease of extensive IT investments and people for physical infrastructure maintenance. From capital expenditure for infrastructure to operational expenses.
Accelerators: leverage pre-built implementation kits, validation toolkits and other techniques for quick implementation and go-lives.
Patching and upgrades: Nextrove owns the complete upgrade process from infrastructure, technical and validation perspective. Client investment is minimal by reducing the overall requirement to business decisions and user training participation.
Nextrove case studies
Three scenarios have been supported by Nextrove in the implementation of hosting projects:
- New Argus implementation: Client is installing Argus for the first time.
- Argus migration and/or upgrade: Client is moving from on-prem or from another vendor to Nextrove cloud
- Argus Upgrade of existing hosted client
Nextrove has provided services for these scenarios as summarized below:
- New Argus implementation
- Latest available version installed.
- End to end implementation services.
Argus migration and/or upgrade ( Client is moving from on-prem or from another vendor To Nextrove cloud)
- Latest available version installed.
- Migration from source Argus/non-Argus systems
- Migration of source documents, audit trail, submission records
- E2B and non-E2B migration
- Lift and shift migration
Argus Upgrade:
- Pre-built implementation kits, validation toolkits and other techniques for quick implementation and go-lives.
In Summary
Nextrove provides cloud hosting for Argus Safety and, by minimizing the effort to manage and maintain systems, supports clients by leveraging technology advancements.
Nextrove supports the process of moving digital operations into the cloud and helps the transfer from on-premises data centers or from legacy infrastructure to the Nextrove cloud through a standard process from consulting and planning to testing and execution.
If you wish to know more about NEXTCLOUD, Nextrove hosting services, reach out to us.
Announcing successful Go-live of LifeSphere Safety Suite implementation in Europe
Nextrove, leveraging its extensive implementation, system integration and data migration expertise, successfully delivered LifeSphere Safety solutions to a mid-size pharmaceutical company in Europe.
Princeton, New Jersey, USA - Nextrove is thrilled to announce another successful Go-live of LifeSphere Safety Suite implementation for one of the mid-size pharmaceutical companies in Germany, Europe.
The projects included migration of 70.000+ cases from Sapheous to LSMV as well as integration of LSRA, and EV Triage. Data migration from existing source system included all case data, submission data, audit trail and source documents. Electronic gateways configuration has also been performed.
Nextrove leveraged proven processes in conjunction with automated and validated proprietary tools to execute the project. Extensive internal team collaboration as well as valued and fruitful client interaction allowed rapid, on-time successful implementation.
About Nextrove
Nextrove, headquartered in New Jersey, USA, is a global professional services firm exclusively serving pharmaceutical and biotech organizations. Its professionals have extensive experience of performing complex integrations between PV, clinical, regulatory, and product quality databases. The company also provides a comprehensive range of tools and accelerators to aid data migrations and analysis of data issues, and fast-track new platform/solution implementations.
Hsiao-Hui Hsu appointed General Manager in China
New Jersey, USA: Nextrove is thrilled to announce that Hsiao-Hui Hsu (Nancy) will be joining our company as Vice President, Business Development and General Manager, China.
Nancy has 29 years of working experience in the sales and marketing field across many industries, such as pharmaceutical, retail, and education, as well as 18 years of management experience. In China market, she has spent over 23 years dedicated to selling software, hardware, SI, and service solutions.
She holds a Bachelor’s degree in International Trade and a Master’s in Business Administration.
"I am Really excited to join Nextrove to expand our footprint in China! Hopefully we can bring our experience, professionalism, services and increase support to China!" - Hsiao-Hui Hsu (Nancy), Nextrove Vice President, Business Development and General Manager, China.
“I am delighted to have Nancy joining our team. We are “very positive” about the mid- to long-term outlook for the Chinese market and we are thrilled to have the chance to expand our footprint in China" - Anjani Jha, Nextrove CEO
About Nextrove
Nextrove, headquartered in New Jersey, USA, is a global professional services firm exclusively serving pharmaceutical and biotech organizations. Its professionals have extensive experience of performing complex integrations between PV, clinical, regulatory, and product quality databases. The company also provides a comprehensive range of tools and accelerators to aid data migrations and analysis of data issues, and fast-track new platform/solution implementations.
Kyung Jun Cha appointed General Manager in South Korea
New Jersey, USA: Nextrove is thrilled to announce that Kyung Jun Cha (Brad) will be joining our company as Vice President, Business Development and General Manager, South Korea.
With over thirteen years of successful experience in sales, marketing, and business development management, Brad is committed to driving the expansion of Nextrove’s presence in Korea and enhancing our relationships with Korean clients. His expertise spans business development, partner management, and sales across various sectors, complemented by a seven-year tenure at Oracle.
He holds an Executive Master of Business Administration (EMBA) degree from the Kelley School of Business, which has equipped him with a comprehensive understanding of business strategies and insights, further augmenting his capabilities to contribute significantly to Nextrove’s success.
"It is a privilege to become part of Nextrove. I am dedicated to leveraging my skills and expertise to contribute significantly to Nextrove's expansion and success in the Korean market.” - Kyung Jun Cha (Brad), Nextrove Vice President, Business Development and General Manager, Korea.
“I am happy to have Brad joining our team. South Korea is making various efforts to globalize its market and we believe in the great opportunities that this market offers" - Anjani Jha, Nextrove CEO
About Nextrove
Nextrove, headquartered in New Jersey, USA, is a global professional services firm exclusively serving pharmaceutical and biotech organizations. Its professionals have extensive experience of performing complex integrations between PV, clinical, regulatory, and product quality databases. The company also provides a comprehensive range of tools and accelerators to aid data migrations and analysis of data issues, and fast-track new platform/solution implementations.
Seamless Implementation of Next-Generation Life Sciences Software: Nextrove and ArisGlobal Announce Global Partnership
Drug Safety teams across the globe now have access to the latest solutions to gain efficiencies and optimize costs via a new strategic partnership between ArisGlobal and Nextrove.
Boston, Massachusetts, USA – February 22, 2024 – ArisGlobal, a leading innovative life sciences technology company and creator of LifeSphere®, has announced a new strategic partnership with Nextrove, an implementation, systems integration, and data migration specialist within life sciences. The partnership creates a larger pool of expert resources available to pharmaceutical organization implement next-generation LifeSphere solutions.
Customers across North America, Europe, United Kingdom (UK), India, China, South Korea, and Japan can leverage LifeSphere products via Nextrove implementation and expertise. The most recent client collaborations include KeyMed Biopharmaceuticals (China), and other pharmaceutical companies from the US, Europe, and Japan. Nextrove will help deliver ArisGlobal’s entire end-to-end LifeSphere Safety platform.
Together, ArisGlobal and Nextrove are able to deliver rapid and accelerated project implementations on-time and to-plan. The integrated team leverages proven, automated, and pre-developed tools with a highly standardized project lifecycle to execute projects with the highest quality and to-budget assurance.
Raj Hattarki, Senior Vice President, Head of Consulting at ArisGlobal, said:
“This partnership marks a significant step for ArisGlobal as it makes it even easier for life sciences organizations worldwide to adopt our sophisticated SaaS platform and modernize their Pharmacovigilance (PV) processes. As frontrunners in embracing state-of-the-art technologies like AI/ML in Drug Safety systems, teaming up with a partner like Nextrove is crucial. Nextrove brings complementary skills in modernizing PV operations and transitioning to advanced systems like LifeSphere Safety. This collaboration is set to speed up implementation process and ensure timely delivery, aligning with the high quality and service expectations our clients deserve.”
Anjani Jha, Chief Executive Officer of Nextrove, said:
“We are delighted at this opportunity to bring LifeSphere to pharma and biotech companies globally. This powerful platform is built on a completely new, cutting-edge technology architecture featuring the latest automation and cognitive computing technologies – something companies are crying out for more than ever. We’re excited at the prospect of streamlining companies’ access to these capabilities, whatever their current technology set-up.”
About ArisGlobal
ArisGlobal, the creator of LifeSphere, is a market leader in global patient treatment technology solutions that is transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan, and China. For more updates, follow ArisGlobal on LinkedIn. www.arisglobal.com. Media Contact Carina Birt, Sarum PR on behalf of ArisGlobal carina@sarumpr.com
About Nextrove
Nextrove, headquartered in New Jersey, USA, is a global professional services firm exclusively serving pharmaceutical and biotech organizations. Its professionals have extensive experience of performing complex integrations between PV, clinical, regulatory, and product quality databases. The company also provides a comprehensive range of tools and accelerators to aid data migrations and analysis of data issues, and fast-track new platform/solution implementations.
Advantages of automation in document distribution
Pharmacovigilance operations involve many transactions of documents and reports. Nextrove Progressive Convey ensures that your stakeholders get the right document, at the right time and in the right format. Progressive Convey is a Nextrove application supporting automated document distribution and tracking.
Automated document distribution creates a paperless environment, eliminating the need to print, to store, to maintain physical copies, to dispatch documents. Documents can be sent and received anytime from anywhere from supported portable devices.
Knowing who, when, and where documents were distributed and having an official record is important for audit purposes and regulatory compliance. Nextrove Progressive Convey supports easy review of documents movement history to demonstrate distribution and to ensure distribution deadlines are met.
Capabilities of Progressive Convey from the business perspective
Progressive Convey, part of Nextrove Progressive suite of applications, is designed for automated, secure distribution and tracking of templated letters, safety documents, follow-up questionnaires to reporters and investigators.
Progressive Convey can automatically distribute safety letters/CIOMS/MedWatch generated from the safety system to investigators. To identify recipients, the application can be integrated with any other company repository.
Additionally, Progressive Convey supports automation in generation and management of follow-up questionnaire by pulling data from any safety system to populate template, to produce the document and, through its distribution engine, automatically distribute to recipients. Responses from reporters can be automatically injected back into the safety system.
Salient features of Progressive Convey from the technology perspective
Built on highly configurable Salesforce platform, Progressive Convey can be integrated with any safety system and supports management of multiple templates for follow-up questionnaires.
Including audit trail and tracking of all document’s movements, Progressive Convey is audit ready and allows generation of reports and dashboard to track and monitor document distribution.
Permissions and data security features ensure that documents can be accessed only by stakeholders who are allowed to.
Progressive Convey easily and seamlessly integrate with safety systems. API Integration allows data flow from both directions, allowing Progressive Convey to send information back to safety system.
Advantages of automation in case intake
Repetitive actions in pharmacovigilance can absorb a lot of time and investment. The journey of a case goes through several iterations and multiple touches from several individuals within the organization. Additionally, a case goes through multiple versions at different times.
Also, the volume of incoming safety information is increasing as new sources of information become available like social media, increasing number program support programs or customer engagement programs.
Multiples interventions in the pharmacovigilance chain pose a risk to the quality of the pharmacovigilance system, to consistency in case assessment, and amplifies inefficiencies.
The PV budget allocated to case processing is a large amount of the total PV budget.
Automation in case intake can help to reduce total cost, to optimize quality and to reduce timelines.
Nextrove Progressive Intake is designed to support automation in case intake helping pharma businesses to improve case accuracy providing repeatable results free of human error, to improve consistency, to absorb increases of volume, to shift the activities from manual entry to more added-value data review and analysis, to reduce total PV cost.
Capabilities of Progressive Intake from the business perspective
Nextrove Progressive Intake is highly configurable to be fully automated where the intake process goes completely touchless from receiving the source data and up to exporting it out to the target safety system. However, depending on the needs, any workflow can be configured to have a manual review/edit as well.
Nextrove Progressive Intake extracts safety and product complaint information from structured and unstructured sources, classify and prioritize them.
Nextrove Progressive Intake can extract information from different structured sources. Additionally, Progressive Intake has advanced capability to automatically extract and structure data from various unstructured /sources, documents, and text through a fully customizable document parser based on advanced OCR engine-Machine Learning enabled.
From the pharmacovigilance business perspective, the application supports automated triage, case validity, duplicate check, identification of initial /follow-up. Additionally, it supports auto encoding with MedDRA and WHO Drug Dictionaries, auto narrative generation, splitting and merging of cases data. It is designed to perform completeness check and to push to safety database workflow per case category.
Salient features of Progressive Intake from the technology perspective
Progressive Intake is built on Salesforce. Salesforce secure cloud is the primary data storage location. The application leverages Nextrove proprietary secured APIs for data extraction, for E2B generation and for E2B Gateway connection.
Nextrove Progressive Intake is technology agnostic and can complement any safety system through direct integration or through gateway. It supports E2B(R2) and E2B(R3) profiles.
It is available on android and iOS devices. It is fully configurable based on client needs and can extract information from structured and unstructured sources. Additionally, it provides a multi-lingual interface.
Nextrove Progressive Intake is a fully validated solution, audit ready and CFR-21 Part-11 and GDPR Compliant. It also provides an interactive dashboard and reports.
Former Pfizer Director of Worldwide Regulatory and Safety Operations Information Management - Reporting and Dictionaries, John (Doug) Sydow, Appointed Senior Advisor at Nextrove, LLC
PRINCETON, N.J., Jan. 12, 2021 - Today Nextrove, LLC., a rapidly growing integrator of pharmacovigilance and clinical solutions, announced that John (Doug) Sydow joined the company as Senior Advisor. Doug joins with nearly 30 years' experience in the pharmaceutical domain, most recently serving as Director, Worldwide Regulatory and Safety Operations Information Management, Reporting and Dictionaries at Pfizer.
"Nextrove is uniquely positioned to focus on multiple facets of pharmaceutical and biotech," said Doug. "I found this a welcome approach as contrasted to the many companies focusing on clinical development or safety as a single line of services."
"Doug has experience in every aspect of pharmacovigilance and product development ranging from solution design, configuration, & build to leading large teams with thousands of global regulatory commitments," said Anjani Jha, Nextrove Founder and CEO. "With these years of experience and determination, Doug has designed, developed, maintained, managed, and led the solutions and processes that continue to serve as a foundation for our industry."
About Mr. Doug Sydow
Spending most of his career at Pfizer, Inc., from locations in Bridgewater, NJ and Collegeville, PA, Doug was most recently Director, Worldwide Regulatory and Safety Operations Information Management - Reporting and Dictionaries. Throughout his tenure, Doug was responsible for global planning and budgeting for all pharmacovigilance systems, safety database implementations and upgrades, change management, custom reporting, global regulatory reporting, and risk management. Prior to acquisitions by Pfizer, Doug worked for Greenstone Healthcare Solutions as a Healthcare Informatics Specialist and The Upjohn Company as a Systems and Programming Specialist. Doug holds a Bachelor of Science, Mathematics and Systems Science degree from the University of California at Los Angeles (U.C.L.A.).
About Nextrove
Nextrove is a premier global lifesciences system integrator providing consulting and software solutions around Pharmacovigilance, Clinical, Hosting, QMS, Regulatory and Commercialization. Nextrove's preeminent and innovative solutions include the Progressive Platform (MICC, Compliance and Convey) powered by Progressive Fusion AI. With Corporate Headquarters located in Princeton, New Jersey and offices in the US, Japan, Europe, Canada, and India, Nextrove's multi-lingual team serves a global clientele 24/7/365. Our resume of over 30 top leading pharmaceutical, biotech, and clinical research organizations clients speak to our commitment to quality, consistency, timelines, and cost-effectiveness