Ennov provides the most comprehensive and flexible software suite for regulated content management in the life sciences industry. From large pharmaceutical companies to emerging biotechs, we are proud to serve over 300 companies in the sector worldwide. We develop innovative, powerful, and easy-to-use software for managing regulated content, data, and processes. Our solutions support the entire R&D continuum of life sciences, including Clinical, Regulatory, Quality, Pharmacovigilance, and Commercial aspects.
A total solution to capture and manage Clinical Trial information
The estimated cost of running a clinical trial in the United States ranges from $20 million for a Phase I trial, to $100 million for a Phase III trial. Each year, clinical trial sponsors invest millions of dollars to improve the efficiency and reduce the costs associated with running trials through the use of technology. Ennov’s Clinical suite provides sponsors and CROs with a comprehensive, end-to-end solution for the capture and management of all clinical trial information, both structured and unstructured, from the earliest stages of planning through execution and close-out. The Ennov Clinical suite consists of Clinical Trial Management, Electronic Data Capture, Randomization, Electronic Patient Reported Outcomes and Electronic Trial Master File software that is available for deployment in the cloud or on premises.
World-class Regulatory content and information management
Regulatory information management at global organizations is rarely integrated and usually consists of collections of spreadsheets, home grown databases, emails and ad hoc reports – each full of redundant and/or inconsistent data. However, as product registrations become increasingly complex and volumes increase, companies are realizing that the ability to answer questions about all regulatory activity in an efficient and timely manner is critical to effective operations that ensure enterprise-wide compliance. The Ennov Regulatory suite unifies Regulatory Information Management (RIM), document management and submission publishing to streamline your Regulatory operations, ensure compliance and reduce time to market.
A comprehensive QMS to improve efficiency and ensure compliance
Ennov’s Quality suite combines the power and flexibility of Ennov Doc, Ennov Process and Ennov Training to create a quality management solution that not only improves operational efficiency but also ensures compliance with industry standards such as 21 CFR Part 11, GxP and ISO. Ennov Quality provides a predefined inventory of quality documentation, processes and workflows that are based on accepted industry standards and best demonstrated practices. This allows Ennov Quality customers to get their system into production quickly and start realizing their return on investment. Ennov Quality, like all Ennov solutions, is very easy to configure and requires no IT skills.
End-to-end human and veterinary PV data collection, reporting and analysis
Pharmacovigilance (PV) data management should be an efficient and accurate process. Ennov’s PV suite provides our clients with the tools necessary to quickly and efficiently capture PV cases, electronically submit PV cases to health authorities and mine and analyzing their PV data to gain useful insight into their products safety profile and have complete confidence that all aspects of regulatory compliance will be met. Ennov’s PV suite consists of a comprehensive ICH E2B compliant database, your choice of case entry tools that include mobile capture and voice-to-text functionality, simplified MedDRA coding, periodic safety report generation, compliant electronic submissions and robust signal detection and data analysis capabilities.
Complete professional event management ensures transparency
Well organized and effectively managed professional events are essential to achieving your marketing goals. These events, when executed successfully, will boost recognition of your brand and products among industry peers and key opinion leaders. But the planning and tracking of the activities required for successful events can be complex and is not without risk. Ennov Commercial is a comprehensive software solution for planning, organizing and monitoring all aspects of professional events including conferences, congresses, symposiums and customer communities while providing visibility and control over the logistics, budgets and regulatory compliance.
Free Access: Gartner 2023 Market Guide for Quality Management System Software
May 24, 2023 12:50pm
Case Study: 6 Months to Deploy and Validate an Enterprise Document Management System across 5 Departments
May 24, 2023 1:28pm
Case Study: Ennov Serves as Global Patient Call Center Platform
May 25, 2023 9:19am
Vice President of Marketing, N.A.
Ennov
Raleigh, North Carolina
