March 19, 2020
“The Dialog Drug Safety Triager has enabled us to save time, introduce multiple efficiencies and switch outsource partners with no disruption. I would highly recommend it.”
We were approached by a top ten pharmaceutical organisation to streamline its global medical literature monitoring for drug safety. Tired of managing multiple systems and sources, it wanted to move forward with one provider and a single, dedicated, and fully validated software application to meets its drug safety reporting obligations.
The bespoke program for the pharmaceutical company needed to include:
- A single approach to the total literature monitoring workflow;
- Supervision of their entire product portfolio – including pharmaceuticals and consumer health products;
- Holistic management of the ICSR (Individual Case Safety Report), aggregate reporting and signal evaluation workflows.
- Oversight of vendor activities and management of KPIs
What We Did
Dialog Solutions assigned a project team to fully understand the client’s workflow, challenges, requirements, objectives, time constraints and budget. The focus of the project was to provide process alignment and standardisation, whilst harmonising search strategies across their organisation.
The company previously relied upon discrete teams to collate references for review. Our search experts provided guidance and expertise to optimise one strategy. Utilising the Dialog® Alerts Manager, we were able to provide easy management and editing capabilities to our client that would fulfil its annual regulatory obligations to review drug safety search strategies. Using the Dialog Alerts Manager audit trail functionality, we were able to ensure that all search strategies were always inspection ready.
Documentation simplification and alignment, and a single quality control process was key to the success of this project. With our input, the client was able to align SOPs (Standard Operating Procedures) and Work Instructions with the end-to-end reference import, review process and reporting outputs.
The project was completed on time and according to agreed project milestones. With the Drug Safety Triager, we developed a full validation package – incorporating a quality control workflow authorised by designated user roles. We removed the risk of interruption to the client’s research by seamlessly migrating all historical data into their new application.
“During our most recent inspection, the reports from Drug Safety Triager allowed us to answer the auditors’ literature questions in four to five hours, rather than the four to five days it would have taken us without Drug Safety Triager and Dialog Solutions.”
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