International Regulatory Information Search
Description of the innovative solution (inputs / outputs / problem solved)
Pharmaceutical companies with products on global markets must find ways to efficiently and consistently manage literature searches – both for strategic and regulatory reasons. Key requirements include the collection, verification and analysis of relevant quantities of data coming from scientific literature (Including PubMed and from regulatory information databases (both institutional and commercial). These activities, if performed manually, are time consuming, repetitive, and prone to errors.
ProductLife Group’s innovative search automation solution is designed to carry out regular — daily, weekly or monthly – literature and regulatory information searches quickly and comprehensively. In addition, the results of each search can be converted into a tailored format and archived according to client needs.
The reports provided are structured with or without advice or impact analysis. If the client requires it, analysis and strategic advice from subject matter experts can be supplied.
By outsourcing this dedicated automation service to ProductLife Group, clients have the assurance that their requirements are being managed by dedicated experts, without the need to invest in these capabilities in-house.
The PLG difference:
- The process is uniform and standardized
- Human error is reduced
- Every step of each activity is logged, which streamlines tracking and auditing
- Ongoing maintenance of client offerings alongside continual solution enhancement
- The existing workflow is not disrupted and the productivity of routine processes are improved from the start, while continuing to improve automation efficiency
- Cost-effectiveness and quick turnaround is assured
- The solution delivers a flexible, scalable response to changing situations
Method & tools
To support clients, PLG creates, implements, and validates a set of company-wide processes to automate periodic searches, and puts them in a readable, tailored, and easy-to-use format before delivery.
The automated searches are based on a keyword list that is easily maintained, updated, and tailored by the end user.
After a search, the results are further consolidated, formatted into an Excel format, and delivered to the stakeholders for medical review and/or for processing.
Additional processes, such as automated summaries and/or relevance evaluation by means of machine learning algorithms can be implemented.
The approach is based on Robotic Process Automation and could also be used as input for a machine learning/natural language processing system.
Tools are validated, comparing results obtained through automation vs. manual searches. Documentation of results is prepared for archival or auditing purposes.
Developed and tested using the open source programming R environment.