Bringing new drugs to the market requires pharmaceutical companies to generate numerous documents that includes pharmacovigilance. Approximately half of the time spent during drug development goes into documenting different processes that includes brochures, clinical trial reports, adverse event reports and more. Although records play an important role in ensuring compliance and reviewing successes within the process, it also takes up a lot of time which slows down the busy researchers and scientists. Document automation offers an effective solution that can boost production without cutting corners.
The process of coming up with a new medicine requires in-depth research. The preclinical stage is essential to guide the scientists as well as the regulatory body towards the next stages of drug production. This process can take several years and requires extensive documentation. Poorly researched documentation can lead to dismissal of submission for a new drug by the FDA or other local regulatory authorities.
Automating the document generation process will ensure that every requirement is met for the submission. Different mandatory sections will be included in the document and errors are avoided.
This document requires a lot of information to make subjects aware of what they are signing up for. Drafting such a document can take days if you have to start from scratch to build it up. Automation software provides a painless solution with templates that are easy to populate and have the document generated quickly and ready for the subject to read through and sign. By automating bulk document creation, researchers can greatly cut the amount of time it takes to get the consent of a subject and they can ensure the subject understands what they are agreeing to be part of.
Collecting different reports from various locations about adverse effects can be a time and labor-intensive task and it is a vital part of pharmacovigilance. This is a vital stage in getting a new drug approved so it cannot be skipped. Instead, document automation can help to collect data and enter it into a template that will be used to create the final report. The software is more accurate when it comes to entering data and can do its work round the clock so it doesn’t matter which time zone reports come from, data will be captured in real-time.
Know how Windward can make your pharma related documents generation easy and flawless.