Safety System Implementation & UpgradeNextrove consultants have extensive experience implementing safety solutions that match your business needs. We are committed to providing best in class services starting from safety system selection through implementation, validation, training and ongoing support.
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
With our proven data migration methodology and experienced consultants, Nextrove helps pharmaceutical companies to reduce delivery timelines and implementation cost without compromising on data quality.
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
We have an excellent understanding of E2B R2 and R3 regulations (EMA, PMDA and NMPA) both from a technical as well as a business standpoint. Combined with our extensive knowledge of safety systems, this allows us to position our clients ahead of the curve when dealing with these new E2B requirements.
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
The Nextrove team has years of experience defining and implementing processes around case processing, aggregate reporting, signal detection, change control, dictionary management, configuration and validation across large and medium drug safety organizations. Our business analysts work with you to help improve the existing process and/or can suggest new methodology and industry best practices.
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
Validation ServicesOur team at Nextrove has many years of experience in all aspects of computer system validation, ranging from validation strategy/planning, script authoring, execution, issue resolution, and documentation.
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
Nextrove has extensive experience implementing PV data marts, configuring out of the box reports and providing on-going support to business users via ad hoc queries and reports from the application or by database extracts.
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.
Key services:
- 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.
Services include:
- Standard or customized slides
- On-site or remote training sessions
- Hands-on exercises
- Access to the training environment
- Assessment test
