Nextrove offers end-to-end PV services with a business-centric and problem solving focus to ensure regulatory compliance, best practices and maximum efficiency.
Our team has an average of over 12 years of life science experience. Each and every one of our professionals come with strong technology and/or business skills, a deep understanding of the drug safety process including industry best practices and excellent communication skills.
At Nextrove, we have performed over 200 safety system implementations, upgrades and data migrations and also help organizations manage their drug safety applications more accurately and confidently. We take pride in not only providing services to meet current regulatory compliance requirements but also positioning our clients to be prepared for future developments. Furthermore, by applying our proven methodology we minimize the impact of system implementations, upgrades and migrations both from the cost perspective as well as the impact on your team’s resources all while ensuring strict compliance to operational and regulatory requirements.
Safety Implementation & Upgrade
We have an average of over 200 combined Argus implementation, database upgrade and data migration project experience involving Argus, Argus Japan, ARISg and E2B Pilots with regulators.
E2B R2 & R3 Offerings:
We have lead E2B(R2,R3) regulatory pilots with FDA, EMA, Health Canada, PMDA and China. We support planning, test registration and formal testing process for both CROs and Pharma clients.
We have proven data migration methodologies and accelerators including DM mappings, code, and DM scripts to help our clients execute projects at a low cost and risk all with no compromise in quality.
Compliance, SOP, Work Instructions:
In order to ensure compliance with 21 CFR Part 11, EMA, PMDA and ICH guidelines, we support with full system and process audits. We also develop SOPs for data management, reporting and other processes.
By leveraging industry best practices, not only do we provide on-time and on-budget delivery while minimizing the impact on your resources, but we are also committed to optimizing the system to allow for efficient operations.
Our services include the following for both hosted and on-premise systems:
- Safety system selection
- Business process design and re-engineering
- Requirements gathering and gap analysis
- System configuration
- Product, License and Studies
- Local and Global workflows
- Reporting Rules
- Access Management and Security
- Dictionary Management (MedDRA, MedDRA-J, WHO Drug, J-Drug)
- Field Labels and Codelists
- Validation Rules
- Auto-Narratives and Letter Generation
- E2B (R3) & E2B (R2) customizations
- Setup of gateway submissions to business partners and regulatory authorities
- Data management, including migration and clean-up
- System architecture design
- Integration with quality management systems
- Development of custom reports
- Periodic and ad-hoc reporting solutions
- Validation strategy, execution and issue resolution
- Admin and end-User training
- Support for go-live & post-implementation activities
Safety Data Migration
Our team has hands-on experience with multiple large, medium and small-size data migrations at pharmaceutical companies of varying size with an impressive track record of customer satisfaction. We have a deep understanding of pharmacovigilance data, including their sourcing and application, to successfully move your organization to modern, more compliant solutions.
Nextrove will work with your team to plan and map out a migration strategy and move data in discrete phases that allow for strict testing, validation, and oversight. Our experts work with clients very closely to ensure full transparency and make sure that the migrated data meets business requirements.
Migration activities include:
- Data migration planning and design
- Impact analysis and action plan for upstream and downstream applications
- Source to target data mapping
- Legacy data profiling & clean-up
- Source data mapping
- Custom report migration
- Validation strategy, execution, and issue resolution
- Cutover planning and execution
- Hypercare support
Furthermore, Nextrove experts have knowledge of XML with XSD technology and hands-on experience with Axway EDI gateway as well as ESM exchange. In addition, we have experience leading many E2B (R2 & R3) pilots with the FDA, EMA, Health Canada, PMDA and China.
The following is a list of our E2B services:
- Requirements analysis and solution recommendation
- Development of E2B and E2B+ profiles for import or export
- Existing E2B profile gap analysis and customization
- Application configuration
- Complete testing of submission with regulatory agencies and business partners
- Conversion of E2B R3 ICSR files into compliant E2B R2 ICSR files
- DTD element extension including an update of ICH BFC validation schema files
- Development of custom accelerator or tool
- End-to-end implementation of all solutions, including validation and training as necessary
Compliance, SOPs and Work Instructions
Our business expertise combined with our technological know-how not only allows our clients to excel in meeting current regulations and addressing business issues but also enables them to be prepared for upcoming changes.
Our services include:
- Gap analysis of current documentation
- SOP planning
- Authoring and review of SOPs and Work Instructions
- Support of full system and process audits for FDA, EMA, PMDA and ICH guideline compliance
We are committed to providing high-quality documentation throughout a project, and validation documents are no exception. We work closely with your quality organization to properly document pharmacovigilance evidence — without encumbering the pace or cost of a project.
Nextrove also has up-to-date validation kits for Oracle Argus, Oracle AERS, and solution-agnostic accelerators. Furthermore, we also offer automated validation scripts that can dramatically minimize validation times and thereby reduce costs for validation.
Our services include validation of:
- Safety System
- Data Migration
- Custom Reports
- Interfaces like EDC systems, etc.
- Automation initiatives
Our validation kit contains:
- User & Functional Requirements
- Traceability Matrix (TM)
- Validation Plan
- IQ/OQ/PQ Protocols
- IQ/OQ/PQ Test Scripts
- Defect Tracking / Resolution Form
- Validation Summary Report
PV Analytics and Reports
Furthermore, at Nextrove we have a proven approach for capturing business requirements, performing a fit-gap assessment, and ultimately designing and implementing custom reports. Our team is proficient in Business Objects™, Cognos™, and OBIEE and consists of dedicated business and technology resources who have multiple years of regulatory experience.
- Implementing data marts
- Periodic safety reports
- Development of custom reports
- Aggregate reports, ad-hoc reports, and metrics
- Reports generated from versioned (eg. DLP) or non-versioned data
Nextrove provides both standard and customized training on the Argus Safety Suite of applications to end users and administrators, including central (core) and/or affiliate sites. Our team has conducted user and admin training for pharmaceutical as well as for biotechnology companies of all sizes in both English and Japanese.
Topics range from case processing and reporting to the configuration of product, licenses, and studies.
- Standard or customized slides
- On-site or remote training sessions
- Hands-on exercises
- Access to the training environment
- Assessment test
Nextrove has extensive experience employing up-to-date validation kits for Oracle Argus, Oracle AERS, and solution agnostic accelerators.
Application User Training:
We provide customized training on the Argus Safety Suite of applications to end users and administrators, including central (core) and/or affiliate sites.
PV Analytics and Reports:
We are highly proficient in implementing simple to complex PV analytics and signaling reports, performing fit-gap assessments, finalizing requirements, and designing solutions.
XEVMPD/ IDMP Assessment:
We provide services around the assessment of impact due to the XEVMPD (future IDMP) on a company’s safety database and product configuration.