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Serious Adverse Event (SAE) Management, Review and Reporting to DCGI during the COVID 19 Pandemic for an Ophthalmology Clinical Study

Patient safety management is a crucial responsibility for Sponsors and Contract Research Organizations during the conduct of clinical trials. The recent COVID-19 pandemic has put forward more complex challenges for all stakeholders to complete adverse event handling and reporting. This case study describes the key challenges, outcomes, and best practices used for timely handling and [...]

Enhancing Clinical Trial Performance with an Innovative Clinical Trial Management System Accelerator

The Business Need 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. There was a critical need to accelerate the process with more effective project [...]

Implementation and Validation of Phase 1 Clinic Automation System for Axis Clinicals

Introduction 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. Key Challenges: It was required to configure ClinSpark as it was a turnkey, enterprise-level system. Existing Axis Clinicals workflows [...]

Argus Safety Cloud Implementation and Validation on Oracle Cloud for HUGEL Pharma

Introduction 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. Key Challenges faced by Hugel: A limited understanding of safety system [...]

Argus Safety Cloud Implementation on Oracle Cloud for KAEL-GemVax

Introduction 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. Key Challenges: Limited understanding of safety system implementation Implementing a fully validated safety system in time to market the drugs End-user [...]

Establishing an Integrated Global Drug Safety and Signal Management Cloud Solution

The Business Need Ipca has over 1500 products registered in 70 countries, and another 600 are in the process of registration in 50 countries. The company’s Drug Safety and Information Technology (IT) groups jointly defined a long-term goal to develop a state-of-the-art,integrated safety and signal platform for managing intake, assessment, and timely reporting of all [...]