ESTERN Medical
ESTERN Medical CRO is a leading full Contract Clinical Research Organization conducting clinical trials across the US, North America, and Latin America. The company specializes in pharmaceutical and medical device development, offering comprehensive support across all phases of clinical development. With strategic Phase I units within hospitals and successful execution of pivotal trials, ESTERN Medical ensures regulatory approvals and post-approval collaborations. Their mission is to build a better CRO through innovation, thorough planning, and global expertise, aiming to accelerate medical advancements and improve patient outcomes.
Industries
Nr. of Employees
medium (51-250)
ESTERN Medical
Cambridge, Massachusetts, United States, North America
Products
Medical Phase
Strategic late-stage drug development services focusing on clinical research and marketing alignment, safety initiatives, and maximizing product life cycle.
ESTERN Medical Phase II & III clinical trial services
Comprehensive program management for Phase II and III clinical trials with robust support systems and international infrastructure.
ESTERN Medical Phase I services
Unparalleled depth and breadth of experience for safe and innovative early-phase human drug development, adhering to GCP and GLP standards.
ESTERN Medical CRO Life Sciences
A clinical research organization specializing in CNS, Psychiatry, and Pain Management clinical trials across the U.S. and Latin America, offering comprehensive Life Sciences CRO services including clinical trial design, consulting, patient recruitment, regulatory guidance, and trial rescue.
Full CRO Services for Cardiovascular Clinical Trials
Comprehensive clinical research organization services specializing in cardiovascular pharmaceutical and medical device clinical development, including regulatory strategy, trial design, protocol development, and patient recruitment.
Oncology Clinical Trials
Comprehensive clinical research services specializing in hematology and oncology, including immuno-oncology, targeted therapies, and cell and gene therapies, supporting all phases of oncology drug development from discovery to commercialization.
Medical Phase
Strategic late-stage drug development services focusing on clinical research and marketing alignment, safety initiatives, and maximizing product life cycle.
ESTERN Medical Phase II & III clinical trial services
Comprehensive program management for Phase II and III clinical trials with robust support systems and international infrastructure.
ESTERN Medical Phase I services
Unparalleled depth and breadth of experience for safe and innovative early-phase human drug development, adhering to GCP and GLP standards.
ESTERN Medical CRO Life Sciences
A clinical research organization specializing in CNS, Psychiatry, and Pain Management clinical trials across the U.S. and Latin America, offering comprehensive Life Sciences CRO services including clinical trial design, consulting, patient recruitment, regulatory guidance, and trial rescue.
Full CRO Services for Cardiovascular Clinical Trials
Comprehensive clinical research organization services specializing in cardiovascular pharmaceutical and medical device clinical development, including regulatory strategy, trial design, protocol development, and patient recruitment.
Oncology Clinical Trials
Comprehensive clinical research services specializing in hematology and oncology, including immuno-oncology, targeted therapies, and cell and gene therapies, supporting all phases of oncology drug development from discovery to commercialization.
Services
End-to-end clinical trial services covering early-phase to post-approval studies, including hospital-based Phase I units and late-phase registries/outcome studies.
Feasibility assessment, selection, initiation and monitoring of investigative sites to ensure enrollment and data integrity.
Recruitment strategy development and use of a maintained participant database to support enrollment across study sites.
Program and project-level management including timelines, vendor coordination and resource allocation for clinical programs.
Assessment and remediation plans for under-performing studies to restore timelines and data quality.
Advisory services for clinical development strategy, protocol design and regulatory planning for pharmaceutical and medical device programs.
End-to-end clinical trial services covering early-phase to post-approval studies, including hospital-based Phase I units and late-phase registries/outcome studies.
Feasibility assessment, selection, initiation and monitoring of investigative sites to ensure enrollment and data integrity.
Recruitment strategy development and use of a maintained participant database to support enrollment across study sites.
Program and project-level management including timelines, vendor coordination and resource allocation for clinical programs.
Assessment and remediation plans for under-performing studies to restore timelines and data quality.
Advisory services for clinical development strategy, protocol design and regulatory planning for pharmaceutical and medical device programs.
Expertise Areas
- Clinical trial management (Phases I–IV)
- Site operations and patient recruitment
- Regulatory affairs and submission strategy (US, EU, LATAM)
- Clinical data management and biostatistics
Key Technologies
- Electronic data capture (EDC) systems
- Clinical data management
- Biostatistical analysis
- Decentralized/virtual trial platforms
News & Updates
Carmen Serfezi, a seasoned senior management executive with over 35 years of experience in healthcare sales, marketing, and operations, has been appointed to the Executive Advisory Board of ESTERN Medical.
During the XVII World Congress of Neurosurgery, a Neurosurgery book honoring Dr. Hernandez’s clinical and scientific medical career was released recently.
ESTERN Medical CRO Life Sciences has become aware of job scams in which fraudsters impersonate company representatives and make fraudulent job offers.
Mr. Daniel Vazquez has joined ESTERN Medical CRO Life Sciences as the Head of Clinical Trials Regulatory Advisory Board.
Within the past years, up to 78% of FDA-regulated clinical trials for the top pharmaceutical & medical device companies are conducted outside the U.S.
In the past 15 months, since the World Health Organization declared Covid-19 as a pandemic, healthcare systems around the globe have been under immense clinical trials R&D and regulatory pressure.
Carmen Serfezi, a seasoned senior management executive with over 35 years of experience in healthcare sales, marketing, and operations, has been appointed to the Executive Advisory Board of ESTERN Medical.
During the XVII World Congress of Neurosurgery, a Neurosurgery book honoring Dr. Hernandez’s clinical and scientific medical career was released recently.
ESTERN Medical CRO Life Sciences has become aware of job scams in which fraudsters impersonate company representatives and make fraudulent job offers.
Mr. Daniel Vazquez has joined ESTERN Medical CRO Life Sciences as the Head of Clinical Trials Regulatory Advisory Board.
Within the past years, up to 78% of FDA-regulated clinical trials for the top pharmaceutical & medical device companies are conducted outside the U.S.
In the past 15 months, since the World Health Organization declared Covid-19 as a pandemic, healthcare systems around the globe have been under immense clinical trials R&D and regulatory pressure.