Ipca is an established Indian pharmaceutical company manufacturing over 350 formulations and 80 active pharmaceutical ingredients for various therapeutic segments. Headquartered in Mumbai, Ipca manufactures and sells branded and generic formulations, APIs and intermediates to 120+ countries. As one of the world’s largest drug manufacturers, they are inspected by US-FDA, UK-MHRA, EDQMEurope, WHO-Geneva, PMDA and many other regional regulatory bodies.
A few products developed by GemVax were ready for marketing, but the organization did not have any safety system in place. They needed validated safety system to be implemented, in time, for marketing.
Hugel Pharma, a global biotechnology firm, had a few approved products that were ready for marketing. The organization, however, did not have a safety system in place. They were looking for a partner that could deliver a safety system in a timely manner.
Axis Clinicals, one of the largest full-service clinical/biopharmaceutical development provider, wanted to implement ClinSpark phase I automation system, to enhance its regulatory compliance. The system being GxP required a formal validation of implementation and conﬁguration.
Enhancing Clinical Trial Performance with an Innovative Clinical Trial Management System Accelerator
Budgets and timelines were not being met due to inefficiencies in the drug development process. While the company had invested in Siebel™, a clinical trial management system (CTMS) by Oracle®, they were not getting maximum benefit from this platform.