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.

Enterprise Architecture

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.

System Selection

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.

System Integration

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.

System Validation

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.