What we offer

Analytics solution that continuously learns from historical submission data to predict potential queries from health authorities on similar future submissions and recommend possible best responses to questions, enabling shorter submission review cycles 

Who is it for

Regulatory affairs teams across R&D, CMC, safety, clinical trials, clinical development, and labeling functions 

Why it’s important

Reduce time for HA query submissions and approvals

Adhere proactively to regulatory requirements

Decide potential label expansions based on past HA queries

How we deliver

Process

NEXT HA Query Management cognitively searches through large data sets of historical responses against similar queries and deploys predictive analytics to assist submission teams with possible best responses. 

The platform continuously learns from historical queries and responses, and uses this learning to preempt potential HA queries against future submissions, enabling proactive addressal, and therefore, shorter review cycles. 

It is able to predict the probability of submission rejections based on absence of information, suggest documentation based on information gaps, as well as predict nuanced requirements and expectations on trials design, documentation and outcome measures. An inbuilt bot also helps with easy search of information within the HA submissions repository.

What makes us different

Domain knowledge on HA query response inbuilt into the product

AI-based recommendations for HA query response management

Integrated chatbot for faster information search

40
Reduction in effort on HA query submissions
100
Compliance
33
Faster turnaround time

Case study