eXcileCR-Clinical Trial Automation Tool

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More than 80,000 clinical trials alone are conducted in the United States per year and about 95% of them are still paper-based. So it is not surprising that as life sciences organizations seek ways to drive efficiency and improve performance, one of the areas most closely scrutinized is the clinical development process. Clinical Data collection and management currently account for up to 60% of the overall clinical trial process, a timeline that drug companies increasingly find unacceptable as they face increasing pressures to test, approve, and market new drugs faster than ever before.

The business needs:

• Integrated clinical trial data, around 80 percent of clinical trials are paper based with a variety of non-descriptive and in-housed developed software applications
• To have access to the data real time from different sites of clinical trials
• To monitor clinical trial for effective management
• To comply with FDA’s CDISC standards, need mapping for FDA submission
• To comply with Security Design with 21 CFR part 11 and auditable
• To minimize noncompliance risks

The Solution - eXcileCR-Clinical Trial Automation Tool

• eXcileCR application leveraged its expertise in clinical intelligence and technology solution to develop, build and streamline the clinical trial process by capturing, authoring, processing, and managing clinical trial data & analysis.
• It is scalable, cost-effective solution that connects not only clinical trial sites across multiple sites but also connects the Clinical Data Management Team , Study Physician, Study Monitor, Clinical Co-ordinator, Bio-statistical Team.
• By standardizing, controlling, and securing clinical trials-related content, we designed a one-stop web-based Clinical Trials solution to reduces the costs of data acquisition and clean up during trials, enables real-time decision-making based on immediately accessible data, and ensures regulatory compliance and faster submission preparation.

Business benefits

• Reduce the CRF design and review time by more than 4 weeks. Choose from standard templates provided in eXcileCR.
• Reduce the number of resources for developing CRFs and printing cost
• Can Set alerts and rules for flagging events
• Distribute real-time information and educate all concerned stakeholders, participants utilizing a customized web-portal
• Work locally but have access globally to make informed decisions
• Reduce the overall development trial (Lab to Launch). Currently the approximate launch is around 12 years.
• eXcileCR based clinical trail process can help cut the time for trials by two-thirds.