
From real world evidence to FDA-approval readiness, Enexa is your partner in advancing the future of medicine.
Real World Evidence Consumer Trials
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Leveraging real-world evidence, industry-leading data collection and aggregation tools as well as AI-enabled reporting, Enexa’s Consumer Direct trials allow our clients to understand the dimensions under influence and can provide meaningful insights such as feasibility data and the potential for repurposing or dual pathway approach.
Together with our technology partner, Managing Life, our clients gain access to patient apps for daily self reporting, clinical reports for inclusion in grant applications or journal publishing, and backend monitoring of study progress.
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Conceptualization / Objective
Protocol Development
Regulatory Review
Participant Recruitment and Consent Process
Trial Implementation
Data Collection & Monitoring
Analysis and Reporting
Final Review - data package and executive summary
Parallel Pace Preclinical Trials
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Enexa’s proprietary process was developed by Dr. Annabelle Manalo-Morgan Ph.D., who has spent her career as a researcher and cell biologist pioneering translational science methodology, and producing data at a rapid pace to accelerate the method of medications going to market. Through our process, Enexa’s team moves assertively from discovery and metadata analysis through complete in vitro studies, arming our clients with the safety and efficacy data necessary to pursue FDA or therapeutic pathways.
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Discovery
Procedural Valuation
In Vitro & In Vivo Studies
Data Collection and Analysis
Reporting - including executive summary and OTC suitability understanding
Human Clinical Trial Readiness
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Enexa and our partners closely collaborate with our clients to ensure clinical trial readiness including thorough understanding and compliance with regulatory requirements, developing a robust trial design, aiding in ethical approvals, and establishing clear protocols for data collection and analysis.
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Clinical Operations (Clinical Leads, Senior CRAs, Project Management, Clinical Study Assistants)
Medical Writing
Study Start-Up Activities
Clinical SOP Development, Training and Implementation
Development of SOP/Processes for Outsourcing and Site Contracting
Meeting Planning Services
Marketing and Product Development