Clinevo Safety

Pharmacovigilance Database

Clinevo Safety is a cloud based, user-friendly, easy to use, regulatory compliant end-to-end Pharmacovigilance / Drug safety system. All-in-one system provides PV Intake, Case Processing, Regulatory Submissions / AS2 Gateway, Analytics, and Safety Signals capabilities under one platform.

ONE PHARMACOVIGILANCE SOFTWARE

Clinevo Pharmacovigilance database / Drug Safety Database includes PV Intake, Case processing, Submissions, AI & Analytics, and Safety signals

LOWER TCO AND EASY MAINTENANCE

Clinevo safety is the best Pharmacovigilance database / Drug Safety database is built on simplified technology stack which provides a lot of configurations and less customizations

CASE COMPLIANCE ALERTS

Clinevo safety is the best drug safety database /Pharmacovigilance database which provides end user alerts for cases nearing due dates

AI & AUTOMATION

Clinevo Pharmacovigilance database / drug safety database comes with Advanced Automation & AI features to lean case processing efforts

DYNAMIC WORKFLOWS

Clinevo safety is the best Pharmacovigilance Database / Drug safety database consists of easily configurable dynamic workflows for expedited case processing

FASTER USER ADOPTION

Pharmacovigilance / Drug Safety business team, CROs, and others can be trained on the Clinevo Pharmacovigilance database / drug safety database within few hours of time

ADVANCED ANALYTICS

Clinevo safety is the best drug safety database /Pharmacovigilance software provides powerful and actionable insights

ANYTIME, ANYWHERE & ANY DEVICE

Clinevo safety is the best Pharmacovigilance software / drug safety software is a user-friendly web application which can be accessed with basic internet / intranet using IE, Chrome and Firefox browsers

REGULATORY INSPECTION READY

Clinevo Pharmacovigilance software / drug safety software Complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.

COST & COMMITMENT

Clinevo Pharmacovigilance software / Drug Safety Software provides transparent optimized pricing with no compromise in functionality,

Clinevo safety isthe best Pharmacovigilance software / Drug Safety Software provides High performance and efficiency.

Clinevo Pharmacovigilance software / Drug Safety Software is built on a secured regulatory complaint infrastructure.

Clinevo safety is the best drug safety database /Pharmacovigilance Database which works towards reduction of end user efforts through constant automation and AI capability enhancements.

MICC Case Intake (PQCs, MIs and AEs)

Clinevo MICC Intake is a web-based tool for Medical Information Call Center (MICC) and PV users to Log, Track and Monitor Product Quality Complaints (PQCs), Medical inquiries (MIs) and Adverse Events (AEs).

ONE INTAKE SYSTEM

Clinevo Pharmacovigilance Call Centre Intake is the best case intake with an one interactive web interface to report and track Product Quality Complaints (PQCs), Medical inquiries (MIs) and Adverse Events (AEs).

PV AND QUALITY SYSTEM INTEGRATIONS

Clinevo Pharmacovigilance Call Centre Intake can be integrated with Standard Pharmacovigilance and Quality system for seamless case and complaints processing

DYNAMIC WORKFLOWS

Clinevo Pharmacovigilance Call Centre Intake provides easily configurable workflows to meet any complex organization requirements for managing Product Quality Complaints (PQCs), Medical inquiries (MIs) and Adverse Events (AEs).

NOTIFICATIONS TO CONSUMERS / REPORTERS

Clinevo Pharmacovigilance Call Centre Intake sends automated email notifications to the consumers / reporters when there are updates from PV / Quality teams on the reported Product Quality Complaints (PQCs), Medical inquiries (MIs) and Adverse Events (AEs).

REGULATORY INSPECTION READY

Clinevo Pharmacovigilance Call Centre Intake complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.

EASY TO USE INTERFACE

The best case intake interface where the Consumers / Reporters can use the Interface without any training to log Product Quality Complaints (PQCs), Medical inquiries (MIs) and Adverse Events (AEs).

TRACKING / TICKETING INTERFACE FOR CONSUMERS

Clinevo Pharmacovigilance Call Centre Intake provides interface to consumers / reporters to track the from PV / Quality teams on the reported Product Quality Complaints (PQCs), Medical inquiries (MIs) and Adverse Events (AEs).

COST EFFECTIVE & HIGH PERFORMING

Clinevo Pharmacovigilance case Intake is the best cost-effective system that comes with transparent optimized pricing. Clinevo intake is the best case intake built on a Committed Infrastructure, hosting, training, business process and 24/7 Application support.

REAL TIME MONITORING, DASHBOARDS AND REPORTING

Clinevo intake is the best case intake which provides powerful and actionable dashboards and reports for real time monitoring and tracking of quality and compliance.

ANYTIME, ANYWHERE & ANY DEVICE

Clinevo Pharmacovigilance Call Centre Intake is the best User-friendly web application which can be accessed with internet / intranet using IE, Chrome and Firefox browsers.

Website Case Intake (PQCs, MIs and AEs)

Clinevo Website Intake is a web-based tool which can be connected to Sponsor / CRO websites to provide Consumers and Reporters a User friendly web interface to report and track Product Quality Complaints (PQCs), Medical inquiries (MIs) and Adverse Events (AEs).

ONE INTAKE SYSTEM

Clinevo Pharmacovigilance Website Intake is an one interactive web interface to report and track Product Quality Complaints (PQCs), Medical inquiries (MIs) and Adverse Events (AEs).

PV AND QUALITY SYSTEM INTEGRATIONS

Clinevo Pharmacovigilance Website Intake can be integrated with Standard Pharmacovigilance and Quality system for seamless case and complaints processing

DYNAMIC WORKFLOWS

Clinevo Pharmacovigilance Website Intake provides easily configurable workflows to meet any complex organization requirements for managing Product Quality Complaints (PQCs), Medical inquiries (MIs) and Adverse Events (AEs).

NOTIFICATIONS TO CONSUMERS / REPORTERS

Clinevo Pharmacovigilance Website Intake sends automated email notifications to the consumers / reporters when there are updates from PV / Quality teams on the reported Product Quality Complaints (PQCs), Medical inquiries (MIs) and Adverse Events (AEs).

REGULATORY INSPECTION READY

Clinevo Pharmacovigilance Website Intake complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.

EASY TO USE INTERFACE

Consumers / Reporters can use the Interface without any training to log Product Quality Complaints (PQCs), Medical inquiries (MIs) and Adverse Events (AEs).

TRACKING / TICKETING INTERFACE FOR CONSUMERS

Clinevo Pharmacovigilance Website Intake provides interface to consumers / reporters to track the from PV / Quality teams on the reported Product Quality Complaints (PQCs), Medical inquiries (MIs) and Adverse Events (AEs).

COST EFFECTIVE & HIGH PERFORMING

Clinevo Pharmacovigilance Website Intake is the best cost-effective system that comes with transparent optimized pricing. Clinevo Pharmacovigilance Website Intake is built on a Committed Infrastructure, hosting, training, business process and provides the best 24/7 Application support.

REAL TIME MONITORING, DASHBOARDS AND REPORTING

Clinevo Pharmacovigilance Website Intake provides powerful and actionable dashboards and reports for real time monitoring and tracking of quality and compliance.

ANYTIME, ANYWHERE & ANY DEVICE

Clinevo Pharmacovigilance Website Intake is the best User-friendly web application which can be accessed with internet / intranet using IE, Chrome and Firefox browsers

Signal Detection

Clinevo Signal Detection is an end-to-end comprehensive, compliant and user-friendly advanced signal detection and management solution for signal identification, assessment, tracking and managing signals.

Clinevo Signal Management is one of the best signal management tool, having inbuilt features meeting all the regulatory guidelines which includes:

Flexible user interface for proactive monitoring

Quantitative and signal detection on aggregate data using signaling algorithms

Provides - Case Counts, New Cases, PRR, ROR, EBGM, EB05, CHISQ

Ability to compare data across sources and data across quarters

Signal Topic Management

Ability to perform signal detection on internal and external data sources (FAERS, EVDAS, VAERS, Clinical Trials and Literature)

Integration with safety reporting module

Dashboards for signal monitoring and summaries

CONFIGURABLE THRESHOLDS

Clinevo Signal Detection Software provides easily configurable rule-based alerts for qualitative and quantitative review.

SINGLE USER INTERFACE

Clinevo Signal Management is a one-stop application for integrated review of identified signals.

AUTO TRIAGING AND TOPICS MANAGEMENT

Clinevo Signal Detection Software saves time and cost by auto triaging the cases and drug events pair, using an in-built rule based engine.

MULTIPLE DATA SOURCES

Clinevo Signal Detection Software provides in built capabilities to connect with Clinevo Safety, Oracle Argus, ArisG and other databases present in the market.

EASY SCIENTIFIC ANALYSIS

Clinevo Signal Management provides the ability to perform analytical processing with tools for case series that triggers signal detection.

FASTER USER ADOPTION

Clinevo Signal Detection Software provides intuitive and an easy to operate system with just a few hours of training.

COMPLETELY REGULATORY COMPLIANT

Clinevo Signal Detection Software complies with 21 CFR Part 11, ANNEX 11, GxP and GDPR guidelines.

SIGNAL MANAGEMENT AND CONFIGURABLE WORKFLOWS

Clinevo Signal Detection Software provides best signal management and role-based to-do lists to process the detected signals.

ANYTIME, ANYWHERE & ANY DEVICE

This user-friendly and best signal detection web application can be easily accessed with internet / intranet using Internet Explorer, Chrome and Firefox browsers.

SIGNAL DETECTION AND MANAGEMENT

Clinevo Signal Management provides easy to manage signal detection rule based on DMEs, Events of Interest, SUSARs and user-defined conditions. Provides ability to view case data in ICSR and Temporal views for assessment for detected signals.

Safety Data Exchange Agreements (SDEA) / PV Agreements (PVA)

Clinevo Safety Data Exchange Agreements (SDEA) / PV Agreements (PVA) is a cloud-based software solution to manage Safety Data Exchange Agreements / Pharmacovigilance Agreements electronically.

The Clinevo (SDEA) Safety Data Exchange Agreements / PV Agreements (PVA) can house all the partner agreements, pharmacovigilance agreements and bind all legal contracts, ensuring that all safety information pertaining to a licensed product is swiftly and reliably returned to the marketing authorization holder so that they may fulfil their legal obligations to compile safety information and to timely submit safety reports.

Clinevo SDEA helps you:

Manage all partner agreements / PV agreements (PVA) in one place.

Follow a lifecycle that begins with establishing a new partner collaboration and ends with termination of the PVA.

Avoid duplication of PV activities by various partners and improve collaboration with partners.

Receive alerts regarding the end Date and tasks of the agreements.

Easily configure workflows for review, approve and publish documents electronically with electronic signatures.

Version control, security and access control, change controls, and audit trails.

COST EFFECTIVE & HIGH PERFORMING

Clinevo (SDEA) Safety Data Exchange Agreements / PV Agreements (PVA) is the best cost-effective system that comes with transparent optimized pricing. Clinevo (SDEA) Safety Data Exchange Agreements / PV Agreements (PVA) is built on a committed infrastructure, hosting, training, business process and 24/7 application support.

EASY TO USE INTERFACE

Clinevo Safety Data Exchange Agreements (SDEA) /PV Agreements (PVA) is a cloud-based software solution to manage Safety Data Exchange Agreements / Pharmacovigilance Agreements electronically which is also easily accessible. Clinevo SDEA comprises user friendly interface so as to facilitate easy and comfortable work experience with the software.

REAL TIME MONITORING, DASHBOARDS AND REVIEWING

Clinevo (SDEA) Safety Data Exchange Agreements / PV Agreements (PVA) provides powerful and actionable dashboards and reports for real time monitoring and tracking of quality and compliance.

ANYTIME, ANYWHERE & ANY DEVICE

Clinevo Safety Data Exchange Agreements / PV Agreements (PVA) is a user-friendly web application which can be accessed with internet / intranet using IE, Chrome and Firefox browsers and on any device that enables real-time site collaboration and document exchange.

EXPIRATION MANAGEMENT & ALERTS

Expiration Management and document expiry alerts. Configurable email and system notifications.

REGULATORY INSPECTION READY

Clinevo (SDEA) Safety Data Exchange Agreements / PV Agreements (PVA) complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.

DOCUMENT LIFECYCLE AND VERSION CONTROL

Robust Documents Lifecycle with Author, Review and eSign/Approval workflow. Automated version controlling with robust Check-in and Check-out functionality.

SHARING AND COLLABORATION

Allows a user to invite external parties to upload and work collaboratively on documents system in a controlled method.