Safety Solutions

In recent years, the pharmaceutical industry has been jolted by high-profile drug safety problems, with catastrophic failures drawing heightened attention to pharmacovigilance practices in the industry. For regulators and manufacturers, the consequences of failing to ensure the safety of products have never been greater. At the same time, increased pressure on controlling costs for research and development programs, and compliance with growing and changing regulatory requirements, have amplified the challenges associated with implementing a successful strategic pharmacovigilance strategy.

MedChannels delivers integrated safety software solutions and services to biopharmaceutical companies and regulatory agencies through our innovative, industry-leading suite of safety products. Each module address the need for Adverse Event Reporting and Applied Data Standards, helping companies meet data submission requirements, identify potential safety problems and better manage risk.

	AER: SafetyNET™
	Adverse Event Reporting (AER) has never been more important for pre-marketing approval and post-marketing benchmarking. This Web-based, high-performance tool enables safety evaluators to track and report on adverse events, providing required documentation for regulatory agencies in the US, EMEA and Japan. SafetyNET supports safety data management and adverse event reporting for both clinical trials and marketed products... read more
	ESS: (ES2) module
	Electronic Study Submissions (ESS) is gaining rapid acceptance by both regulators and vendors due to the speed and efficiency with which data may be reported - - radically reducing the time it takes to get a product to market. MedChannels’s (ES2) module, together with the SafetyNET adverse event tracking and reporting system, provides a comprehensive solution for safety data collection, management and submission... read more