Change and complexity are bywords within the pharmaceutical industry. HighGear addresses these issues with stunning simplicity, rendering change management easier to implement, yet encouraging collaboration and innovation.
HighGear’s pharmaceutical BPM offering allows you to automate critical processes, collate into one central; repository your body of knowledge and enterprise data, and provide your teams the ability to engage and collaborate with one another, processes and enterprise assets like never before.
Critical process automation speeds up protocol creation and modification, including clinical trial start up and management processes, and investigator/partner site management and remuneration.
Data management optimization with a non-repudiable audit trail and compliance log, ties information and data from across your organization and partners into one, centralized repository.
Trial management is simplified and improved using one, universal work platform across the organization.
Mobile collaboration and accessibility encourages and empowers social collaboration and proactive innovation.
Easily customized task-types and forms provide a unique experience for investigators to explore.
Full audit trail and non-repudiable compliance log recording every input and change on one BPM platform, provides a total compliance solution without audit pain.
Proactive and consistent regulatory compliance throughout the enterprise.
Achieve total transparency in real-time, into all business processes, and together with social collaboration and unified data management, make compliance a state-of-mind and positive by-product of full accountability and visibility.
Full reporting and distribution, including automatic access and denial to information set by role-based permissions, e.g. distribute one report, automatically customized to deliver only that information and data they are permitted to have access to while allowing all information to be delivered to those with authorization.
Research & Development
Full accountability and exceptional collaboration across the enterprise improve decision making and outcomes.
Enhanced productivity is gained from a centralized knowledge and data store, gathered from across the enterprise, divisions, team, and individuals, both internal and external to the organization, including partners, customers and patients.
Fuel innovation with social communication and collaboration bringing people, process and assets together constructively.
Decrease R&D “dead time” by automating paper-based processes, including reporting and distribution.
Increase competitive positioning by making execution faster and delivery much more sustainable than ever before.
Drug Safety – Pharmacovigilance (PhV)
Eliminate human reporting error by automating manual case management, handling Adverse Events (AEs) together with a full compliance log. HighGear ensures you have fast and fully compliant reporting of an identifiable patient, identifiable reporter, suspect drug and adverse event.
Reduce costs and increase speed across the PhV process from signal detection, through to adjudication and changing labeling (including meeting 15-day Expedited Reporting and 7-day SUSAR Reporting requirements).
Speed making correct decisions with Mobile technology integrated with social communication tools, allowing for anywhere, any device access.
Total visibility, in real-time, of all PhV components no matter where reported within the enterprise’s systems.
Strengthen and deepen knowledge and information of PhV issues and events, providing greater context and detail at the fingertips of any authorized user.