NuLEAP For Bio Equivalence

NuLEAP for BE (Bioequivalence) is the flagship product of the company
It is an end-to-end automation solution for execution of bioequivalence studies for Pharma companies and CROs

Highlights

• Out-of-the-box solution
• Powerful suite of pharma-specific tools
• Aims at integrating the various silos in the bioequivalence process
• A web-enabled enterprise software application for Contract Research Organizations and pharmaceutical companies performing bioequivalence studies
• Addresses virtually all of the key requirements of a bioequivalence organization from protocol designing to study execution, volunteer registration to clinical lab sample management, all the way to documentation and reporting
• Consists of a suite of user modules such as clinic management, protocol management etc. supported by a strong NuLEAP engineering platform
• Highly configurable approach to allow frequent changes to the deployed solution – changes can be done without any change at the base product, thereby considerably reducing the validation impact & downtime

Principles

• All-in-one solution
• Enter once, use many
• No manual re-entry – reduce transcription errors, increase throughput
• Choice of level of automation & sophistication
• Hybrid solutions available (Mix of on-line and off-line modes)
• Choice of online/offline recording of activity details
• Achieve regulatory compliance
• Configure solution to fit needs, not the other way around
• Reduce learning curve in lab – save cost, increase productivity