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Case Studies

Collective experience of 150 plus years in design, development, business process automation, drug safety systems configuration & integration, testing and validation and project management.

Case Study: Data Migration


Problem: 

Companies going thru MAH Transfer, change safety systems to Industry standard Argus Safety or any other platform have challenge of migrating data across varied database structures.

Resolution:

Our consultants have come with tremendous expertise in the area, have developed an effective methodology and process over a period for faster data migration in quality manner

Outcome:

Drug Safety Data Migrated data across global safety platforms including but not limited to Adverse Events case data, business configuration, patient, reporter, submission history etc.

The source and target systems include but not limited to Argus Safety (including J), ArisG, ARISJ, Clintrace, ES1, Perceive and home-grown systems.

Case Study: Wrong Submission


Problem: 

A leading CRO started submissions to FDA using Argus Safety after MAH transfer, new SAFETYREPORTID generated by Argus. This led to wrong submissions for cases which were already submitted by prior MAH holder using SAFETYREPORTID generated by legacy system.

Resolution:

Designed, developed and deployed custom and scalable solution to handle the varied needs of different clients of CRO.

Outcome:

Manual intervention in submission removed, saving of about 15% of the cost in case processing achieved.

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