Life Science Sector

Overview

In life science sector the primary goal of our solution is to reduce time to market of the drug. To do this we have three solutions in the following R&D areas regulatory submission, clinical trials management and deviation management.

Challenge

The us individually go through each of the challenges in the three R&D departments.

Clinical Trial:

Often the problem here is the clinical trial takes too long and this increase the costs of the trial. Major problem is the long patient recruitment time and the drop off rate of patients midway.

Regulatory Submission:

Typically it takes about 8 to 9 months from start of an NDA until we get all the approvals.This delays time to market and this has to be optimized

Deviation Management:

Deviations are critical and depending on type it could also halt production unless the root cause is identified fast and fixed before the issue spreads across the production plant. Results

Clinical Trial:

With our operational AI solutions the AI agent is able to answer why patient recruitment takes long. Are there any clinical quality issues when it comes to consent handling, How is patient engagement maintained by clinical sites and its patients all these factors if fixed could improve clinical trial cost and time needed.

Regulatory Submission:

Typically the hand off between various departments like clinical, non clinical, CMC, toxicology, quality and regulatory might lead to issues eventually leading to delays in submission or even improper submission which could lead to resubmission which is expensive and time consuming. Our operational AI is capable to understand this context and predict or recommend actions to reduce approval time.

Deviation Management:

Some deviation are critical as they might impact multiple products (eg. contamination) and some are less critical. Hence, the operational AI agent will understand these dependencies and create prioritisation framework where it can classify high and low priority deviations based on its impact.Also for the high priority deviations it will ensure the root cause analysis, CAPA verification and CAPA implementation happen in time to avoid any major risks.