Ethica CRO
Ethica CRO is a full-service Contract Research Organization specializing in ethical clinical research for the pharmaceutical, biotechnology, medical device, nutraceutical, and cosmeceutical industries. Founded in 2002 by Janice Parente, it is recognized for its commitment to protecting research participants and maintaining high standards of research integrity. Ethica CRO employs a multidisciplinary team with extensive scientific expertise to manage complex clinical trials, including those involving medical aesthetics, dermatology, respiratory diseases, and more. The company is the first CRO worldwide to obtain full accreditation of its Human Research Protection Program and is dedicated to advancing innovative therapies through rigorous and ethical research practices.
Industries
Nr. of Employees
small (1-50)
Products
Medical affairs
Strategic and logistical support for Medical Affairs related research including proof-of-concept studies, Investigator-initiated-trials, and meta-analyses.
Phase IV Medical Affairs Studies
Specialized Phase IV research strategies including marketing support, proof of concept, product differentiation, and explorative new indication studies.
Phase IIIb-IV
Comprehensive clinical research services for Phase IIIb and IV studies, including post-market and observational studies, customized investigator-initiated trial (IIT) support, and regulatory compliance management.
Phase I-III Clinical Research Services
Comprehensive clinical study management and biometrics services for Phase I through III clinical research studies.
IIT Support
Comprehensive support for investigator-initiated trials ranging from feasibility assessment and budgeting to clinical study monitoring and data management.
Investigator Initiated Trials (IIT)
Study management, data management, and biostatistical services geared specifically to the needs of Investigator Initiated Trials.
Medical affairs
Strategic and logistical support for Medical Affairs related research including proof-of-concept studies, Investigator-initiated-trials, and meta-analyses.
Phase IV Medical Affairs Studies
Specialized Phase IV research strategies including marketing support, proof of concept, product differentiation, and explorative new indication studies.
Phase IIIb-IV
Comprehensive clinical research services for Phase IIIb and IV studies, including post-market and observational studies, customized investigator-initiated trial (IIT) support, and regulatory compliance management.
Phase I-III Clinical Research Services
Comprehensive clinical study management and biometrics services for Phase I through III clinical research studies.
IIT Support
Comprehensive support for investigator-initiated trials ranging from feasibility assessment and budgeting to clinical study monitoring and data management.
Investigator Initiated Trials (IIT)
Study management, data management, and biostatistical services geared specifically to the needs of Investigator Initiated Trials.
Services
End-to-end management of multi-site clinical trials including protocol development, site oversight, monitoring, TMF maintenance and FDA-ready documentation.
Clinical database design, eCRF implementation, query management and real-time data monitoring for multicenter studies.
Statistical analysis plan development and advanced modelling (e.g., GEE) for complex and heterogeneous clinical endpoints.
Selection, validation and deployment of electronic PRO platforms, including device compatibility, accessibility features and participant support.
Site training programs, on-site monitoring and remote oversight focused on protocol adherence, injection techniques, outcome assessment and data integrity.
Design and execution of long-term observational and retrospective studies to inform safety, satisfaction and market positioning.
End-to-end management of multi-site clinical trials including protocol development, site oversight, monitoring, TMF maintenance and FDA-ready documentation.
Clinical database design, eCRF implementation, query management and real-time data monitoring for multicenter studies.
Statistical analysis plan development and advanced modelling (e.g., GEE) for complex and heterogeneous clinical endpoints.
Selection, validation and deployment of electronic PRO platforms, including device compatibility, accessibility features and participant support.
Site training programs, on-site monitoring and remote oversight focused on protocol adherence, injection techniques, outcome assessment and data integrity.
Design and execution of long-term observational and retrospective studies to inform safety, satisfaction and market positioning.
Expertise Areas
- Clinical trial management (Phase I–III)
- Dermatology and medical aesthetics research
- Respiratory disease clinical research
- Investigator-initiated trials (IIT) support
Key Technologies
- Electronic patient-reported outcome systems (ePRO)
- Electronic case report forms (eCRF) and clinical databases
- Clinical data visualization and analytics
- Standardized clinical photography platforms
News & Updates
A case study showcasing a scar treatment project by a US-based biotechnology company leveraging fibromodulin-based peptides, managed by Ethica CRO.
A case study on managing clinical trials for inhaled mannitol in cystic fibrosis patients, highlighting technical and regulatory solutions.
A detailed case study on a scar management project using injectable peptides, demonstrating Ethica CRO's expertise in complex clinical trials.
An overview of the upcoming summit focusing on data science in skincare.
An article discussing the advantages and challenges of using electronic PROs in clinical trials for medical aesthetics.
An overview of how Ethica CRO's expertise supports dermatology clinical trials.
A case study showcasing a scar treatment project by a US-based biotechnology company leveraging fibromodulin-based peptides, managed by Ethica CRO.
A case study on managing clinical trials for inhaled mannitol in cystic fibrosis patients, highlighting technical and regulatory solutions.
A detailed case study on a scar management project using injectable peptides, demonstrating Ethica CRO's expertise in complex clinical trials.
An overview of the upcoming summit focusing on data science in skincare.
An article discussing the advantages and challenges of using electronic PROs in clinical trials for medical aesthetics.
An overview of how Ethica CRO's expertise supports dermatology clinical trials.