Aarti Tatke, Technical Lead – Medical Writer, GENINVO
24th Dec, 2020
With Innovation and AI (artificial intelligence) making way into clinical research, it took time to establish a place in the medical writing domain. The process began with an attempt to automate the generation of documents that reuse clinical information. However, medical writers were not comfortable with the use of cumbersome software versus the quality of output generated. With advancements in technology, multiple options became available to the medical writers that provided meaningful alternatives to speed up the medical writing process.
So far, the exercise to automate the document quality check (QC) or review process have yielded partial success. Tools today, only offer to check grammar, punctuation, language consistency and a few mere metrics.
There were few challenges in bringing automation and gaining efficiency in the medical writing process:
- Due to the nature of the documents, there are multiple ways of representing the data-heavy documents and no standardized format
- Knowing what to focus on while performing Quality Checks in limited time is equally challenging
- As requirement for each document is usually different, consistency and time allocation are tough, although they must be delivered at the earliest although QC is the last step
- And finally, the QC process needs to be documented and findings need to be addressed and annotated with a justification as well.
All these challenges have existed for a long time, as the amount of data gathered during clinical trials is also huge and needs to be reported in a concise manner. There are also other factors such as urgency, lack of sufficient time, changing regulatory requirements and human dependency that impact the quality of Quality Checks for Medical Writing Documents.
How we bring in the GENINVO Difference
As solution, due to advances in data capture, there is real-time availability of “clean data,” which leads to better time management. With enhanced communication systems and automation opportunities, the said challenges are addressable in today’s world. To be able to fully overcome the problems, organizations require a dedicated software. And that is where DocQC fills the gap.
With DocQC, you have the following advantage:
- Checks are programmable and runnable in the background so the scope of QC is defined, and writers can focus on other tasks at hand.
- It can run complex checks within minutes, to verify consistency of data against source documents as well as across documents representing the same data.
- Since the checks are programmable, human error is negated. Users train and test the system in advance.
- For the future, simplified sequential autorun checks and the ability to read and verify data in text against respective sources should be a priority. The user should also be able to configure specific requirements on their own, as per individual project requirements.
Observing the effects of change in Innovation, whether it results in failure or success, is one of the keys to improvements and developments in healthcare. When the change is something new or involves the process of introducing something new, the results should benefit healthcare. The criteria for innovation in health is then achieved.
Beyond satisfying these criteria, newly introduced ideas, methods, products, and/or the process of introducing something new in healthcare face the additional burden of adoption in the field. In addition to these hurdles, external demands of stakeholders, funders, regulators, competitors, consumers, and general accountability must be met.
By understanding what is innovative and what is not, as well as the barriers to adoption and implementation, we are better able to conceptualize what is necessary in the field to bring about long-lasting and large-scale developments for increased efficiency and effectiveness in various areas of healthcare.