Clinical and Safety Services Decision-Support Platform Designed to Accelerate Drug Discovery and Development

KEM Clinicals, a new version of the decision-support platform KEM-Knowledge Extraction and Management, has been developed to support the clinical development and safety process.

Ariana Pharma (Paris, France), a provider of decision support tools and services to accelerate drug discovery and development, has launched the system, which is available as a service offering to pharmaceutical and biotechnology companies. KEM Clinicals has been developed in response to the demand for designing improved clinical trials speedily. KEM Clinicals is not only capable of testing hypotheses (as other methods do), but more importantly it will generate exhaustive robust hypotheses consistent with existing data relevant to the objectives sought. This addresses the problem of eliminating the bias stemming from poor initial information, a daunting and recurrent difficulty when using conventional statistical methods, and is one of KEM Clinicals' key characteristics.

To rapidly achieve the client's objectives for clinical trial analysis, KEM Clinicals uses combinations of the following features: improved protocol design (optimal inclusion/exclusion criteria); early adverse events detection and characterization; identification of surrogate endpoints; design of new composite efficacy/safety endpoints; optimizing benefit/risk ratio through exhaustive responder analysis and characterizing populations at baseline. Moreover, using KEM Clinicals will enable existing Ariana customers to shorten significantly the timeline for clinical trial data analysis by up to six weeks--typically from 10-14 weeks to 8-10 weeks.

The decision support provided by KEM also helps expedite product registration and it can be used for effective product repositioning. "These major new enhancements show that Ariana has delivered on its commitment to expand further the capabilities of KEM, and allow the company to enter a new growth area, that of efficient clinical trial data analysis,” said Mohammad Afshar, Ariana Pharma's CEO.

KEM already held significant advantages over traditional numerical methods by providing exhaustive analysis, generation and prioritization of hypotheses, an easy to interpret system, the handling of missing data, and multi objective optimization. "The earlier version of KEM already offered highly innovative techniques for Clinical Trials but KEM Clinicals will have a significant impact on efficacy and in producing reliable and exhaustive results fast,” added Mr. Afshar.

Ariana Pharma provides multi-objectives decision support tools to accelerate and improve the discovery, development, and safety of pharmaceutical products. Its KEM knowledge extraction and management platform comprehensively mines data, and helps scientists take simultaneous decisions involving multiple criteria and objectives.

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