Three Challenges in Life Sciences: Medical Affairs, Compliance, and Regulatory Affairs
March 3, 2021, 3 Minute Read
I’d like to talk about three related Life Sciences functions that are – let’s face it – facing unparalleled unstructured big data challenges. As patients become more empowered, they are accessing research, writing in discussion boards, using social media, calling medical call centers… and, there is a huge burden to capture these touchpoints in digital formats. What are you doing to drive insight from such touchpoints? The important Pharmaceutical functions that must be responsible for insight generation and strategic actions against this data are the following: Medical Affairs, Quality & Compliance, and Regulatory Affairs. Although these functions are not traditionally IT-driven, they will be. At the end of a digital transformation journey, can you envision a highly intelligent and responsive enterprise that is capable of key human interactions involved in regulation, quality, and provider discussions? Lymba wants to help you achieve this kind of precision and efficiency in these critical risk-reduction functions.
Natural Language Processing capabilities are key to driving a usable digital transformation.
Companies are trying: one company doubled its accuracy of auto-coding of adverse events to MedDRA (Medical Dictionary for Regulatory Activities) from 30 percent to 60 percent. [1]
Pharmacovigilance functions are expanding their use of population sampling and spontaneous reporting events. [2]
Examination of published off-label trial event data could reveal increased risks to patients and profits. Introspection in Case Report Forms (eCRF) and adjudication of event reporting could drive more automated workflows for Pharma and regulators. What if your company was first to implement across a multiplicity of such use cases? Can you implement in a coordinated, enterprise-wide fashion? Do you have the Natural Language Processing Platform tools to enable your work? Here are some potential areas Lymba may help with:
Medical Affairs
Extract clinical trial and medical affairs information to help strategically integrate their functions.
Develop touchpoint integrations for commercial operations, monitoring, sales support, and CRM automations.
Collect and collate real world evidence (RWE) from natural language unstructured text.
Quality & Compliance
Support monitoring of compliance and SOP documentation.
Perform regulatory compliance gap analysis.
Regulatory
Maintain and scrape regulatory submissions.
Lymba will work with you to help you advance your digital transformation goals. We would love to discuss your current state processes, pain points, strategic goals, and key performance metrics. Let’s together help drive your executive agenda and ultimately support innovation for patients. Contact us today!
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