Enhancing BABE Studies with Advanced EDC

Accelerating First-to-Market Success in Generics

Bioavailability and Bioequivalence (BABE) studies are critical gateways to bringing safe, effective, and affordable generic medicines to market. With over 90% of US prescriptions filled by generics, ensuring robust clinical execution and data integrity has never been more important.

Digital Precision Meets Scientific Excellence in Bioequivalence Research

At Navitas Life Sciences, we partner with global generics sponsors to deliver fast, efficient, and regulatory-compliant BABE studies, strengthened by modern digital systems that enhance quality, accelerate timelines and improve data confidence.

Why EDC Technology Matters for BABE Studies

Traditional manual systems and basic eCRF tools can slow down data cleaning, introduce delays and increase compliance risk, especially in studies where precision PK sampling, chain-of-custody and subject safety are paramount.

Purpose-built Electronic Data Capture (EDC) systems are transforming BA/BE execution by enabling:

• Real-time data capture & verification
• Automated edit checks and compliance alerts
• Secure storage and traceable audit trails
• Integration with bioanalytical workflows
• Faster database lock and regulatory submission readiness

BABE programs demand systems designed specifically for pharmacokinetic workflows and stringent 21 CFR Part 11 and GCP requirements, strengthening trust and traceability from first volunteer check-in to final submission.

Digital Innovation to Power Better BABE Outcomes

Our digital approach to BABE studies is designed to enhance integrity, oversight, and speed across the full clinical workflow, from volunteer enrollment to PK/PD reporting and regulatory filing.

Key advantages include:

To further strengthen data quality, auditability, and real-time oversight, we leverage secure EDC systems tailored for BABE study workflows, enabling:

• Improved clinical trial data quality through automated edit checks, real-time validation and PK/PD-driven workflows
• Time-saving for starting and managing studies, ensuring rapid setup, volunteer onboarding, dosing and sampling schedule execution
• Simplified and automated clinical data management with guided workflows and central monitoring to reduce manual effort
• Validated standardized data capture aligned with global regulatory expectations, ensuring accuracy, traceability, and repeatability across studies
• Flexible block or site randomization schemes with integrated CTMS for seamless planning, controlled enrollment, and audit-ready oversight across clinical pharmacology units and study sites.

This clinical, along with a digital ecosystem delivers audit-ready, validated and reproducible outputs, supporting faster study close-out and confident ANDA submissions.

Navitas Life Sciences – Your BABE Excellence Partner

With decades of experience in generics and specialty studies, Navitas Life Sciences brings deep scientific, regulatory, and operational expertise:

• 1,500+ BABE studies completed
• 500+ validated bioanalytical methods
• 100+ regulatory approvals from BABE studies
• Dedicated CPU facilities & advanced MS platforms
• Expertise in complex generics, inhalation and euglycemic clamp studies

Our end-to-end BABE solutions cover:

• Study design & regulatory strategy
• Volunteer recruitment & unit operations
• Bioanalytics & PK/PD
• CDISC-compliant biostatistics & data review
• Submission support & pharmacovigilance

Whether it is immediate-release, modified-release, complex formulations, inhalation or clamp studies, our teams ensure accuracy, speed and compliance.

Partner With Us to Accelerate Your Generic Drug Program

Bringing a generic drug to market requires compliance and efficiency, and that’s where Navitas Life Sciences’ proven BABE and digital expertise deliver value.

To know more about our services and solutions, reach out to us at This email address is being protected from spambots. You need JavaScript enabled to view it..