Pv-works software

Traditional software providers have products that require months-long implementation processes and multi-million-dollar investments. And with a highly regulated and workflow-dependent industry like pharmacovigilance, there are troves of standard operating procedures in place.

With competing priorities and strained resources, the seemingly logical read: easier approach has been one of quick fixes. Analytic jammed in SOP here But it's quickly become clear to many drug safety professionals that "quick fixes" aren't working anymore. And, even worse, those supposedly quick fixes may actually be stifling true innovation in the industry. With modern software-as-a-service and agile approaches to development, it doesn't have to be this way.

Forward thinking pharmacovigilance departments are realizing this and taking steps today to adapt and move their processes forward. Complex data integrations and modern analytics can't sit on top of traditional workflow tools. In a data-first world, those workflow tools need to be built in and around the data and analytics that drive decision making. And, yes, those workflow tools still need to comply with GVP best practice and regulatory requirements, but they must also allow for the flexibility to continue to expand in the future.

It is clear that there are more data than ever for pharmacovigilance departments to leverage in their signal detection, validation, and evaluation work flow. However, the legacy software being used by most organizations limits the insight that can be gained from these data. There is a growing wave of general discontent by pharmacovigilance departments with the status quo.

Adding new technology to address the concerns of modern pharmacovigilance is a short-term priority. Advera Health's Evidex platform has been built, and continues to be enhanced, in partnership with our clients to solve the challenges of the modern pharmacovigilance department.

An agile, flexible approach to data, analytics, and workflow allows for quick implementations that can meet the scale of both large and small organizations. Legacy pharmacovigilance software providers in this market have products that require months long implementation processes and multi-million dollar investments. And with a highly regulated and workflow dependent industry like pharmacovigilance, there are troves of standard operating procedures in place.

New dataset jammed into an SOP there It's quickly become clear to more and more drug safety professionals that "quick fixes" aren't working anymore. And, even worse, may be stifling true innovation in the industry. Read more about legacy vs. Evolution of PV Software. PV Software Trends. Trend 1: Pharmacovigilance departments want to use new data sources but are finding it hard to operationalize them all.

Safety data can be categorized into three buckets: company owned, curated, and licensed data. Core Capabilities. ICH E2B compliant safety data collection and reporting Coding of cases against current MedDRA dictionary Extensive data validation, cross-field checks and use of pick lists Duplicate check functionality Integrated spell checker Integrated query tool Automated letter generation Case data export.

Key Features. Manages spontaneous and clinical trial adverse events, technical inquiries and product complaints Compatibility with with third-party query and reporting tools Easy to configure workflows that match existing business processes Streamlined case review and data approval concept Supports pharmaceutical, biological, medical device, and cosmetic vigilance Available as cloud-based or on-premises deployment FDA 21 CFR Part 11 compliance.

Download Now. Learn more. PV-Works Vet. PV-Signal Manager. Why Choose Ennov? Hundreds of corporate customers trust Ennov. Highly scalable. User-centric design. Our commitment to your success Very high customer satisfaction, Providing you freedom of choice.

Available as cloud-based or on-premises deployment You can switch between deployment options at any time. We make you autonomous System configuration and management require no IT skills. Improved security and optimized performance Data is hosted locally for total flexibility. Cloud-based or On Premises. A purpose-built workflow engine is integrated with comprehensive safety functionality in order to provide management control of pharmacovigilance processes.

PV-Works Vet is easily integrated with standard AS2 gateway software to manage electronic submissions. Acknowledgement messages and batch submissions are comprehensively handled. The import of compliant XML formats is also fully supported , allowing receipt of cases submitted to industry directly from European Competent Authorities. The import function is also implemented by Regulatory agencies using PV-Works Vet upon receipt of electronic submissions from industry.

The PV-Works Vet electronic reporting function is updated in line with regulatory changes. Very high customer satisfaction, Data is hosted locally for total flexibility. Single-tenancy minimizes business interruptions. Ennov pharmacovigilance suite. Contact Us. The Pharmacovigilance Challenge. Workflow is fully integrated with safety functionality and data handling Management functions including team supervision and workload balancing PV-Works Vet also includes a wide range of powerful querying functionality , allowing business teams to monitor case handling, track compliance, and execute in-depth trend analysis.

Advanced Capabilities Ensure Compliance. View Product Brief. Core Capabilities. VICH compliant safety data collection and reporting Coding of cases against current VeDDRA dictionary Extensive data validation, cross-field checks and use of pick lists Duplicate check functionality Integrated spell checker Integrated query tool Automated letter generation Case data import and export.

Key Features.