Clinical R & D is one of the areas where there is high scope to create a great number of efficiencies. Use of artificial intelligence (AI) and automation can change the way we design, manage, conduct, analyze, oversee and report our clinical trials and provide the transformation change that the industry has been looking for decades. Not only this, the revolution will offer more standardization and uniformities within the functions & cross functions as well.
MakroCare utilizes Clin.Ai platform which has re-designed some of the traditional processes in clinical trial space using Artificial intelligence & automation to transform these processes to create significant efficiencies for sponsors/CROs, standardization of processes, better control and quality execution of clinical trials. Clin.Ai works on two basic principles of increasing automation in the processes wherever possible and keeping human intermediation minimal. Clin.Ai has capabilities to build 30% – 50% efficiencies in some of the processes and functional areas.
Applications/Benefits of Clin.Ai to support sponsors in clinical trials:
CDM Activities: Clin.Ai also help to create significant automation in CDM activities. From eCRF /EDC set up, building relevant edit checks to promote automation in query management areas to validation, medical review up to database lock is automated using Clin.Ai keeping minimal human intermediation.
Clin.Ai also works well for other processes like Source data verifications, resources planning and some of the study start-up activities like EC/IRB, regulatory dossier preparation, review and compliance, start-up document management etc.
Apart from creating high efficiencies in these processes, the other direct advantages that sponsors/CRO will have from Clin.Ai to create standardization in operations by reducing variability in processes some of which because of variation in human approach and procedural differences.
Auto Risk & Issues identification:
With CRA shortage and clinical monitoring expense contributing to increased development costs, Clin.Ai truly is a blessing. With its inbuilt NLP technology and risk library, all clinical monitoring reports (whether pdf or word) are automatically analyzed by Clin.Ai and probable risks and issues along with deviations are matched against our built-in library and brought to Project management team as probable risks or issues. This will minimize Sponsor oversight and also reduce co-monitoring visits.
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