Repetitive actions in pharmacovigilance can absorb a lot of time and investment. The journey of a case goes through several iterations and multiple touches from several individuals within the organization. Additionally, a case goes through multiple versions at different times.
Also, the volume of incoming safety information is increasing as new sources of information become available like social media, increasing number program support programs or customer engagement programs.
Multiples interventions in the pharmacovigilance chain pose a risk to the quality of the pharmacovigilance system, to consistency in case assessment, and amplifies inefficiencies.
The PV budget allocated to case processing is a large amount of the total PV budget.
Automation in case intake can help to reduce total cost, to optimize quality and to reduce timelines.
Nextrove Progressive Intake is designed to support automation in case intake helping pharma businesses to improve case accuracy providing repeatable results free of human error, to improve consistency, to absorb increases of volume, to shift the activities from manual entry to more added-value data review and analysis, to reduce total PV cost.
Capabilities of Progressive Intake from the business perspective
Nextrove Progressive Intake is highly configurable to be fully automated where the intake process goes completely touchless from receiving the source data and up to exporting it out to the target safety system. However, depending on the needs, any workflow can be configured to have a manual review/edit as well.
Nextrove Progressive Intake extracts safety and product complaint information from structured and unstructured sources, classify and prioritize them.
Nextrove Progressive Intake can extract information from different structured sources. Additionally, Progressive Intake has advanced capability to automatically extract and structure data from various unstructured /sources, documents, and text through a fully customizable document parser based on advanced OCR engine-Machine Learning enabled.
From the pharmacovigilance business perspective, the application supports automated triage, case validity, duplicate check, identification of initial /follow-up. Additionally, it supports auto encoding with MedDRA and WHO Drug Dictionaries, auto narrative generation, splitting and merging of cases data. It is designed to perform completeness check and to push to safety database workflow per case category.
Salient features of Progressive Intake from the technology perspective
Progressive Intake is built on Salesforce. Salesforce secure cloud is the primary data storage location. The application leverages Nextrove proprietary secured APIs for data extraction, for E2B generation and for E2B Gateway connection.
Nextrove Progressive Intake is technology agnostic and can complement any safety system through direct integration or through gateway. It supports E2B(R2) and E2B(R3) profiles.
It is available on android and iOS devices. It is fully configurable based on client needs and can extract information from structured and unstructured sources. Additionally, it provides a multi-lingual interface.
Nextrove Progressive Intake is a fully validated solution, audit ready and CFR-21 Part-11 and GDPR Compliant. It also provides an interactive dashboard and reports.