Amarex Clinical Research
Amarex is a full-service, global Contract Research Organization (CRO) dedicated to expediting patient access to safe and effective clinical products. With extensive experience in clinical research across various therapeutic areas, Amarex offers comprehensive services including project management, regulatory affairs, clinical operations, data management, biostatistics, medical monitoring, and pharmacovigilance. The company is committed to high-quality, cost-effective clinical product development and has a strong track record of helping sponsors obtain market approvals for numerous products. Led by a diverse leadership team, Amarex fosters a culture of innovation, collaboration, and excellence to support complex clinical trials and product development.
Industries
Nr. of Employees
Very Large (1000+)
Amarex Clinical Research
Germantown, Maryland, United States, North America
Products
Web-based EDC and IRT platforms (real-time eCRFs and IRT)
Hosted web-based electronic data capture for real-time eCRFs, integrated with interactive response technology for randomization and trial supply management and with online clinical site registration.
Amarex Accelerated COVID-19 Product Authorization/Approval Services
Expert regulatory and clinical trial testing services to accelerate FDA approval and clinical trial timelines for COVID-19 products, including emergency INDs, Phase 2 and Phase 3 clinical trial approvals, and multiple regulatory submissions.
Electronic Data Capture (EDC) System
A proprietary electronic data capture (EDC) platform supporting real-time data entry and monitoring with built-in validation checks, instant access to data metrics, remote monitoring, and seamless integration with safety and statistical workflows.
Post-Market and Pharmacovigilance Services
A full suite of post-market and pharmacovigilance services for pharmaceutical, biologic, and medical device companies, grounded in ISO 14971 risk management standards.
Data Management
Real-time data management capabilities for sites and sponsors using a 100% web based system.
AI-Driven Pharmacovigilance & Post-Market Surveillance
An intelligent safety solution by Amarex Clinical Research that uses AI and ISO 14971-aligned risk management to help pharmaceutical, biologic, and medical device companies detect risks earlier, respond faster, and ensure global regulatory compliance while reducing operational burden and improving ROI.
Web-based EDC and IRT platforms (real-time eCRFs and IRT)
Hosted web-based electronic data capture for real-time eCRFs, integrated with interactive response technology for randomization and trial supply management and with online clinical site registration.
Amarex Accelerated COVID-19 Product Authorization/Approval Services
Expert regulatory and clinical trial testing services to accelerate FDA approval and clinical trial timelines for COVID-19 products, including emergency INDs, Phase 2 and Phase 3 clinical trial approvals, and multiple regulatory submissions.
Electronic Data Capture (EDC) System
A proprietary electronic data capture (EDC) platform supporting real-time data entry and monitoring with built-in validation checks, instant access to data metrics, remote monitoring, and seamless integration with safety and statistical workflows.
Post-Market and Pharmacovigilance Services
A full suite of post-market and pharmacovigilance services for pharmaceutical, biologic, and medical device companies, grounded in ISO 14971 risk management standards.
Data Management
Real-time data management capabilities for sites and sponsors using a 100% web based system.
AI-Driven Pharmacovigilance & Post-Market Surveillance
An intelligent safety solution by Amarex Clinical Research that uses AI and ISO 14971-aligned risk management to help pharmaceutical, biologic, and medical device companies detect risks earlier, respond faster, and ensure global regulatory compliance while reducing operational burden and improving ROI.
Services
Comprehensive project management, quality assurance, site contracting, feasibility, monitoring and trial oversight for clinical programs.
Regulatory strategy development, preparation and submission of IND/IDE/510(k)/PMA/NDA/BLA, FDA meeting support and orphan designation assistance.
Real-time, web-based data capture and data management services including eCRF implementation and SDTM dataset conversion.
Conversion of raw clinical data to SDTM and implementation of CDISC standards for regulatory submissions.
Strategic eTMF implementation and operational management to maintain a regulatory-compliant trial master file.
Statistical design, SAP development, SAS programming, analysis and reporting for clinical trials including integrated safety and efficacy summaries.
Comprehensive project management, quality assurance, site contracting, feasibility, monitoring and trial oversight for clinical programs.
Regulatory strategy development, preparation and submission of IND/IDE/510(k)/PMA/NDA/BLA, FDA meeting support and orphan designation assistance.
Real-time, web-based data capture and data management services including eCRF implementation and SDTM dataset conversion.
Conversion of raw clinical data to SDTM and implementation of CDISC standards for regulatory submissions.
Strategic eTMF implementation and operational management to maintain a regulatory-compliant trial master file.
Statistical design, SAP development, SAS programming, analysis and reporting for clinical trials including integrated safety and efficacy summaries.
Expertise Areas
- Clinical trial management
- Regulatory strategy and submissions
- Data management and SDTM conversion
- Electronic data capture and clinical systems
Key Technologies
- Web-based EDC / real-time eCRF systems
- Interactive response technology (IRT)
- SDTM / CDISC data standards
- Electronic Trial Master File (eTMF) systems
News & Updates
New Trial to Study Progerinin Treatment for Ultra-Rare Condition
New Designation Marks Milestone in Glioblastoma Treatment Decades in the Making with Glioma Treatment that Crosses Blood Brain Barrier at Ten Times Concentration Needed to Kill Cancer Cells
Amarex Clinical Research to Manage Phase 2 Clinical Study of a New Therapy for COVID-19 Long-Haulers
Amarex will manage a Phase 2, randomized, double-blind, placebo-controlled, multicenter study evaluating Ampligen for Post-COVID-19 Cognitive Dysfunction.
The NSF Health Science Journal features contributions by Amarex, including a white paper on oncology trial designs and an interview with a visiting scientist from the Korean MFDS.
Amarex announced receipt of positive survival results for AIM ImmunoTech's pancreatic cancer therapy.
Contributions include a white paper on Safety Risk Management, an interview with a Korean MFDS trainee, and work on COVID-19 clinical products.
New Trial to Study Progerinin Treatment for Ultra-Rare Condition
New Designation Marks Milestone in Glioblastoma Treatment Decades in the Making with Glioma Treatment that Crosses Blood Brain Barrier at Ten Times Concentration Needed to Kill Cancer Cells
Amarex Clinical Research to Manage Phase 2 Clinical Study of a New Therapy for COVID-19 Long-Haulers
Amarex will manage a Phase 2, randomized, double-blind, placebo-controlled, multicenter study evaluating Ampligen for Post-COVID-19 Cognitive Dysfunction.
The NSF Health Science Journal features contributions by Amarex, including a white paper on oncology trial designs and an interview with a visiting scientist from the Korean MFDS.
Amarex announced receipt of positive survival results for AIM ImmunoTech's pancreatic cancer therapy.
Contributions include a white paper on Safety Risk Management, an interview with a Korean MFDS trainee, and work on COVID-19 clinical products.