Our Work in Pharmacovigilance
Astrix provides strategic consulting services that enable the success of end-to-end Pharmacovigilance (“PV”) planning, design, and implementation as part of our comprehensive suite of services. Astrix experts know first-hand that the PV landscape is evolving and that our clients prefer a strategic IT partner (rather than an IT vendor) who understands and collaborates in solving challenges throughout the Requirement, Design, Implementation, Testing and Go-live phases of SDLC. Astrix achieves results using proven methodologies during guided and collaborative sessions led by highly experienced PV pros who keep our client’s needs at the forefront of every decision. Together we determine the optimal implementation strategy and business roadmap, as well as third-party software and hosting choices that represent the best fit for our clients.
For over a quarter century, Astrix has specialized in the scientific and pharmaceutical market providing close support for informatics services to sector-leading companies. Our focus in assisting pharmaceutical and biotech companies, is to enable the information management infrastructure essential to drug R&D, safety, and regulatory compliance today and well into the future.
- Strategic Services
- Enterprise Architecture
- Data Management and Governance
- System Selection Consultation
- Program Leadership
- Project Management
- PV Process Design and Optimization
- Data Migration Mapping and Execution
- System Implementation and Upgrade
- System Integration
- System Validation
- SOP Planning
- E2B R2/R3 regulatory pilot
Download our Brochure
Get a copy of our updated brochure detailing our Pharmacovigilance Practice and the various services provided within this overall category.
Strategic Services for Pharmacovigilance
We bring new approaches to solving complex Pharmacovigilance business problems that propel forward movement via innovative thinking, collaboration, process optimization, data-centricity, and consideration of emerging technologies. A comprehensive plan is specifically designed to transform end-to-end workflows, data flows, and identify technology opportunities. Once completed, we can lead or assist in follow-on activities to achieve the envisioned future PV business capabilities.
Our team identifies challenges, gaps, barriers, and opportunities within your current Pharmacovigilance technical environment and collaborates with you to co-create the desired future technical and data ecosystem.
Data Management and Governance
We construct pragmatic strategies and frameworks for data governance, assessments of data quality, and planning for optimized management of digital assets across the PV organization.
Astrix specializes in managing system evaluations, selections and implementations of third-party software, as well as providing services that integrate optimized systems into organization infrastructures. Our vendor Evaluation and Selection Service begins with a System and Technology Assessment. In this assessment, we utilize a thorough, best-practice method to assess your current (As-Is) environment, determine and validate your requirements, develop a future (To-Be) state, evaluate the market, and present you with a list of vetted commercial solutions that meet your requirements.
Given the number of different solutions on the market for Pharmacovigilance and Safety, it can be challenging to maintain a current understanding of the different options to the degree that enables an effective decision in a timely manner. At Astrix, we make it our business to stay current on all relevant trends and products in the Pharmacovigilance and Safety areas.
Program Lead, Project Management
Having the right individual with both industry and implementation experience can make the difference to any project or workstream. Astrix provides seasoned professionals to oversee or lead your project or an experienced PM to manage your project or workstream. Our team will provide industry best services to manage your project including documents such as project plans, project charters, and issue and risk registries as well as applying our methodology including project governance, escalation model and communication strategy.
PV Process Design and Optimization
Astrix team members have worked with safety organizations evaluating their current business process, assessing gaps and future needs, and developing a future state process. We will take into consideration your safety system capabilities and optimize your business process to take advantage of the system’s unique capabilities.
Data Migration Mapping and Execution
Whether you are moving to a new system, acquiring a new product, or receiving data from a partner or other company, Astrix experienced migration experts can ensure that your data is migrated cleanly and efficiently. Our detailed mapping sessions will analyze your current source data and work with you to determine the best way to map it to your future system. Once the mapping document and requirements are completed, our technical team will develop a series of migration scripts to efficiently and effectively migrate your data.
System Implementation and Upgrade
Our team of experts have been involved in some of the largest and most complex system implementations. Using our industry and system knowledge, we will guide the team through the implementation process leveraging our experience and maximizing the system capabilities.
Many of our clients require integrations with third party or custom software. Both technical and industry knowledge is required for success. During our workshop sessions, we will define the business and technical requirements for each integration. Then working with appropriate internal and external members, develop and test the required integrations.
In order to ensure compliance and that the system meets your requirements, detailed testing documentation is required. We will work with you to develop well defined validation strategy document, user requirements, traceability matrix, validation test scripts and summary report.