The Progressive Intake Series: Episode 2: Document Intake – Advanced AI-Driven Data Extraction
In the world of pharmacovigilance and product complaint management, organizations often face the challenge of processing large volumes of data embedded within documents or unstructured text. Nextrove Progressive Intake addresses this with innovative, AI-driven solutions that transform diverse document formats into structured, actionable case data.
By harnessing the power of advanced artificial intelligence, this feature eliminates the inefficiencies of manual data entry, ensuring faster and more accurate case management.
Intelligent document intake for seamless data transformation
Progressive Intake excels in processing data from various document sources, offering unparalleled versatility and precision.
- Versatile Document Support: Whether dealing with PDFs, Word files, emails, or even handwritten forms, Progressive Intake can seamlessly handle diverse document types. Its ability to manage both structured and unstructured content ensures consistent conversion into standardized case data.
- AI-Powered Data Extraction: With cutting-edge AI technology, Progressive Intake intelligently analyzes and extracts critical information from documents. This reduces manual effort, accelerates processing times, and minimizes errors, enhancing the overall efficiency of case intake.
- Bulk Data Handling: Progressive Intake simplifies the management of high case volumes with support for bulk data ingestion via Excel and E2B XML files. This capability ensures speed and accuracy even when processing extensive datasets.
Key Advantages
- Versatile Document Support
- AI-Powered Data Extraction
- Bulk Data Handling
Why choose Progressive Intake for document processing?
By leveraging AI-driven document intake, Progressive Intake empowers organizations to streamline data capture, reduce manual intervention, and improve the accuracy and efficiency of their adverse event and product complaint management workflows.
Stay tuned for Episode 3 in this series, where we’ll explore how Progressive Intake automates case processing to ensure compliance and operational excellence in your pharmacovigilance activities.
Ready to take your pharmacovigilance operations to the next level? Let’s talk!
Connect pharmacovigilance business with technology
At Nextrove, we specialize in bridging the gap between pharmacovigilance business processes and advanced technology. With extensive experience in business integration, process redesign, system assessment, and solution development, we empower organizations to achieve greater efficiency and effectiveness in their operations.
In today’s rapidly evolving landscape, it’s essential to continually evaluate and improve your pharmacovigilance processes. Quicker, automated, and more effective workflows not only reduce costs but also keep your systems aligned with the latest technological advancements. Simply getting the job done is no longer enough—your processes and systems must evolve to remain effective and competitive.
The benefits of process simplification and optimization
Simplifying and optimizing pharmacovigilance systems and processes can deliver significant benefits for organizations. Nextrove streamlined workflows eliminate unnecessary steps and leverage automation, resulting in increased efficiency.
By aligning Nextrove tools and processes to their full capabilities, companies can reduce inefficiencies and realize substantial cost savings. Simplification also enhances scalability and quality by avoiding workarounds and quick fixes, ensuring easier maintenance and more robust operations.
Furthermore, our optimized tools and intuitive workflows improve user engagement, reducing barriers for end-users while boosting motivation and productivity.
Nextrove’s Harmonization Approach
To help you achieve these benefits, Nextrove employs a structured, three-phase harmonization strategy tailored to your organization’s needs:
Phase 1: Current “As-Is” State – Assessment & Diagnostics
Objective: Analyze the existing processes and systems to identify potential areas for improvement.
- Apply and enforce standards.
- Enable high-quality outputs.
- Eliminate workarounds and rework.
- Ensure consistency in processes.
- Align systems with business objectives.
- Boost productivity by streamlining workflows.
Phase 2: Future “To-Be” State – Improvements
Objective: Develop actionable solutions for identified improvement areas.
- Create detailed specifications for improvement opportunities.
- Conduct review sessions to gain agreement and approval.
- Examine and refine documentation.
- Assess and align systems with business requirements.
- Quantify and communicate the potential benefits.
Phase 3: Implementation
Objective: Deliver and implement the agreed-upon improvements.
- Align systems and processes to the proposed changes.
- Update documentation to reflect new workflows.
- Provide clear communication and comprehensive training for end-users.
Unlock the potential of technology for pharmacovigilance
By connecting pharmacovigilance business processes with cutting-edge technology, Nextrove enables organizations to thrive in a competitive and fast-changing environment.
Whether it’s streamlining your processes, optimizing tools, or ensuring system alignment, we’re here to help you unlock new levels of efficiency, quality, and user satisfaction.
Ready to take your pharmacovigilance operations to the next level? Let’s talk!
The Progressive Intake Series: revolutionizing adverse event and product complaint management
In an increasingly complex regulatory landscape, managing adverse events and product complaints requires more than just traditional systems. Organizations need solutions that are robust, secure, and adaptable to the ever-evolving demands of compliance and operational efficiency.
Progressive Intake, Nextrove’s flagship product, is built on the reliable Salesforce platform, delivering unmatched security, scalability, and intelligence. Designed to streamline the intake process, enhance data accuracy, and ensure compliance, Progressive Intake is the future of case management.
Episode 1 - seamless data capture across multi-channel input solutions: Web forms
Nextrove Progressive Intake transforms how organizations capture and manage adverse event and product complaint data by offering versatile multi-channel solutions, including customizable web forms.
Web forms are often the first point of interaction for users submitting adverse events or product complaints, and Nextrove Progressive Intake enhances this process with advanced, customizable forms that are intuitive, user-friendly, and aligned with your organization’s brand, ensuring a seamless experience and accurate data capture.
- Effortless Integration: Progressive Intake’s web forms integrate seamlessly with your website or secure portals, maintaining a cohesive and professional user experience that reflects your brand identity.
- Data Integrity Assurance: Built-in validation mechanisms ensure that submissions are complete and accurate. Mandatory fields, format checks, and error prompts eliminate inconsistencies, enhancing data quality at the point of entry.
- Instant Confirmation: Users receive a unique reference number immediately after submission, offering a reliable point of reference for future inquiries or follow-ups.
Key Advantages
- Effortless Integration
- Data Integrity Assurance
- Instant Confirmation
Why Progressive Intake?
Harnessing the power of Salesforce, Nextrove Progressive Intake delivers the reliability and security you need for managing sensitive case data while offering the flexibility to adapt to your organization’s unique requirements. By streamlining the intake process and enhancing the accuracy of captured data, Progressive Intake helps your team focus on what truly matters—delivering safer, more effective solutions for your patients and customers.
Stay tuned for the next article in this series, where we’ll explore how Progressive Intake integrates advanced automation to optimize case processing and ensure compliance across global regulatory standards.
Ready to take your pharmacovigilance operations to the next level? Let’s talk!
Nextrove: Comprehensive Pharmacovigilance Solutions
In today’s fast-paced regulatory environment, the ability to manage safety systems efficiently and effectively is critical for pharmaceutical and life sciences organizations. Nextrove delivers a robust suite of services designed to streamline operations, ensure compliance, and drive informed decision-making. From issue resolution to advanced analytics, Nextrove’s expertise empowers businesses to meet the challenges of modern pharmacovigilance (PV).
Our Managed Services span a comprehensive range of operations, tailored to meet the unique needs of the PV sector. By leveraging our global expertise, companies can strengthen their PV infrastructure, ensuring all systems and processes align with industry best practices and international regulatory standards.
Swift Issue Triage and Resolution
When time-sensitive issues arise, they can disrupt workflows and jeopardize compliance. Nextrove collaborates closely with your business and IT teams to rapidly identify, prioritize, and resolve problems within agreed Service Level Agreements (SLAs). Our experts meticulously document each resolution and deploy fixes in accordance with your Standard Operating Procedures (SOPs), ensuring consistency and reliability.
Routine Updates to Stay Ahead
Keeping pharmacovigilance systems current is essential for maintaining compliance. Nextrove proactively manages routine updates, including:
- Administering access controls
- Updating key dictionaries such as MedDRA, WHO Drug, and J Drug.
- Managing products, studies, and reporting rules.
These updates ensure your systems remain aligned with evolving industry and regulatory requirements, minimizing risks and improving operational readiness.
Comprehensive Configuration Maintenance
As regulations evolve, system configurations must adapt. Nextrove provides full-spectrum maintenance services to keep your systems optimized, including:
- E2B updates and ESM profile modifications.
- Axway partner integrations and pilots with regulators such as EMA, FDA, and Chinese authorities.
- PMDA connectivity tests and updates to reporting destinations.
- Workflow adjustments, field validations, narratives, and letter template updates.
Our tailored approach ensures seamless operations across diverse regulatory frameworks and geographies.
Efficient Change Management
Change is an inevitable part of pharmacovigilance, and Nextrove specializes in managing it effectively. We follow client-specific or internal SOPs to oversee every step, including:
- Requirement gathering and analysis.
- Implementation, validation, and deployment across all environments.
This structured methodology minimizes disruptions and ensures the successful integration of new processes and technologies.
Advanced Reporting and Analytics
Accurate reporting and actionable insights are critical for informed decision-making. Nextrove offers an extensive range of reporting and analytics services, including:
- Ad-hoc reporting and audit /inspection preparation.
- Aggregate reporting, such as PADER, PBRER listings, CIOMS II Line Listings.
- Monthly signal detection reports.
- Advanced metrics and dashboards using tools like OBIEE, BIP, BO, Cognos, and SQL queries.
These capabilities enable organizations to improve operational efficiency while making proactive, data-driven decisions.
Key Solutions
Issue Triage & Resolution
We collaborate with your business and IT teams to swiftly triage and resolve issues within agreed SLAs. Our team documents fixes and deploys them according to your SOPs.
Routine Updates
We manage access and audits, update MedDRA, WHO Drug, and J Drug dictionaries, and oversee ongoing product, study, and reporting rules management.
Configuration Maintenance
Our services include E2B changes, ESM profile updates, Axway partner updates, E2B pilots with the EMA, FDA, and China, PMDA connectivity tests, and updates to reporting destinations, email recipients, workflows, field validations, narratives, and letter templates.
Change Management
We execute change management using client or internal SOPs, leading requirement gathering, analysis, implementation, validation, and deployment across all environments.
Reporting and Analytics
We handle ad-hoc reporting requests, audit support, aggregate reporting (PADER, PBRER listings, CIOMS II, and Line Listings), monthly signal reports, and advanced metrics using OBIEE, BIP, BO, Cognos, or SQL queries.
Staff Augmentation
Enhance your team with Nextrove’s skilled professionals from the US, Canada, EU, China and India. Our resources are available for temporary or long-term roles, acting on your behalf and working under your supervision.
Staff Augmentation with Global Expertise
Pharmaceutical companies often require flexible access to skilled professionals. Nextrove provides highly trained experts from the US, Canada, EU, China, and India for both temporary and long-term engagements. These professionals integrate seamlessly into your teams, working under your supervision while delivering expertise tailored to your specific needs. With global reach, we ensure your organization has the right talent at the right time.
Why Partnering with Nextrove?
Key Advantages
Enhanced Compliance
Improved Efficiency
Data Security
Scalability
Cost Savings
Expertise and Experience
Nextrove’s Managed Services are designed to enhance compliance, and efficiency of your pharmacovigilance operations, allowing your organization to focus on innovation and patient care. As the healthcare landscape grows more complex, robust PV systems are critical for managing safety data and ensuring regulatory adherence.
- Enhanced Compliance: We help organizations meet stringent global regulatory standards, and ensuring operational continuity.
- Improved Efficiency: By streamlining processes and deploying advanced technologies, we minimize manual tasks and enable teams to focus on high-value safety assessments.
- Data Security: Protecting sensitive information is a cornerstone of modern pharmacovigilance. Nextrove implements robust measures to safeguard data and prevent breaches.
- Scalable Solutions: Our services are designed to grow with your organization, adapting seamlessly to increasing data volumes and evolving regulatory demands.
With a global presence and extensive industry experience, Nextrove equips pharmaceutical companies with the tools and expertise to build resilient PV systems that address today’s challenges while preparing for future growth.
Partner with Nextrove for Pharmacovigilance Excellence!
Nextrove is your trusted partner in navigating the complexities of pharmacovigilance. Whether you’re managing routine operations, implementing strategic changes, or enhancing analytical capabilities, we deliver solutions that drive results.
Ready to take your pharmacovigilance operations to the next level? Let’s talk!
Nextrove achieves ISO 27001 certification
About Nextrove
Nextrove leads the industry in Pharmacovigilance Professional Services and Solutions. Our unwavering mission, “Empowering Clients to Improve Patient Safety,” propels us on the path to realizing our vision of becoming the first choice for Life Sciences professional services and solutions, in service of our clients, partners, and, above all, the patients we ultimately serve.
www.nextrove.com
info@nextrove.com
+1 347 551 1700
Nextrove LLC.
116 Village Boulevard,
Princeton Forrestal Village, Suite 208
Princeton, NJ 08540, USA
Nextrove achieves ISO 27001 certification
November 2024, New Jersey
Nextrove is proud to share the achievement of ISO 27001 certification!
ISO 27001 is a globally recognized standard that ensures our systems, processes, and policies are designed to protect sensitive information and maintain the trust of our clients and partners.
This significant milestone reflects our commitment to the highest standards of information security management.
This underscores our unwavering commitment to information security and demonstrates our dedication to safeguarding our clients’ sensitive data.
By implementing robust security measures and maintaining the highest standards of operational excellence, Nextrove aims to build trust and confidence with every engagement.
Nextrove thanks each and everyone involved in this process and appreciates the talented team for their hard work and commitment in achieving this milestone.
We are excited to continue enhancing our services while prioritizing security and compliance.
Key Highlights:
- Robust Information Security Management: Our processes have been rigorously evaluated and improved to safeguard sensitive information.
- Continuous Improvement: This certification reinforces our dedication to ongoing risk management and operational excellence.
- Client Assurance: Clients can trust that their data is handled with the utmost care and in compliance with international standards.
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
About Nextrove: About Us - LinkedIn - Contact us
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.
About Nextrove: About Us - LinkedIn - Contact us
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.