Speeding up Regulatory Submissions Through Evalueserve’s Searchable Data Repository
Collecting relevant data for a regulatory submission is an extremely effort-intensive task, especially when collecting information surrounding a specialized subject. An FMCG company was having difficulty in toxicology data management involving identification, collection of data, and maintenance of updated physchem (eco)toxicology and clinical data. The client spent a lot time mining around 50 publicly available databases to gather sufficient data. Furthermore, the client faced challenges when procuring chemical-specific supplier data since it required close and timely coordination with the suppliers.
Our team tackled the client’s data and procurement challenges by improving their data mining practices, strengthening communication between their suppliers, and ensuring that their data was reliable and accessible through a combination of experts and technology.
Our team of experts with toxicological skills broke down the solution for the client into five parts to improve the client’s regulatory submission: specialized data mining, communication and coordination with the client’s suppliers, the analysis of all data collected, and structuring data into user-friendly formats.
Part 1: Specialized Data Mining
Human and environmental safety experts and chemists worked in close coordination to source and retrieve publicly available information. We structured the process in a way that allowed specialized teams to focus on core critical areas like clinical and preclinical data, physchem data, ecotoxicology data, and environmental fate. Our team’s transparent approach to research ensured that the client had full oversight of the process and obtained the preferred structure of output containing the best quality of data.
Part 2: Strengthening Supplier Communication
Our team communicated extensively with client suppliers to procure raw material specific data (e.g. MSDS, certificate of analysis, any scientific/toxicology data etc.) to ensure that the raw data inputs are accurate and up-to-date.
Part 3: Thorough Data Analysis
The data was manually analyzed by our team for relevancy and reliability. Our team carried out expert judgment-based assessment of the data quality (e.g. Klimisch scoring for toxicity data).
Part 4: Accessible and Searchable Data Repository
All relevant and reliable scientific data was archived online into the client’s hosted library/repository by mapping test material identifiers (CAS RN and synonyms) with data; each piece of data was mapped with appropriate test type data quality scoring. The data was structured and archived into user-friendly formats. These formats ensured that the client would be able to easily access and apply the information gathered quickly and efficiently.
Part 5: Periodic Data Repository Update and Maintenance
To maintain consistency and accuracy, our team established a structured routine to conduct periodic checks in all the data sources to capture any relevant new data. This ensured that the client always had the most updated version of data at the ready.
Through our five-step solution, the client was able to ensure that their data mining practices were specialized and quick, collected data was reliable and relevant, and their data could be easily accessed through a searchable repository. The client was able to plan, prepare, and manage their regulatory submission items through our improved data mining process.
Accessible and Searchable Repository:
The client’s team was able to easily access and apply the information.
Reliable and Relevant Data Collected:
Our team’s manual analysis of the client’s data ensured that it was quickly and thoroughly assessed.
Improved Submission Times:
The improved data mining process ensured that the client could reach their planned submission times.