Clintract
Clintract is a leading clinical research organization providing comprehensive services including clinical trial management, monitoring, regulatory consulting, medical writing, and legal trial auditing. Founded in 2006, it aims to advance human health through innovative, high-quality clinical research solutions, supporting pharmaceutical, device, nutritional supplement, and botanical companies worldwide.
Industries
Nr. of Employees
small (1-50)
Clintract
Atlanta, Georgia, United States, North America
Products
Clinical Trial Management
Comprehensive clinical research organization services providing medical expert and clinical trial management and auditing services to pharmaceutical, device, nutritional supplement, and botanical companies.
3rd Party Contract Management
Clintract delivers beginning-to-end clinical logistics and 3rd party management by lowering costs and improving compliance and efficiency in all aspects of angiotensin and clinical trial processes.
Informed Consent Form Development
Professional services for writing and developing ICH and GCP compliant Informed Consent Forms for clinical trials.
Consulting Services
Expert consulting services for medicinal and device product development.
Clinical Trial Protocol Development
Comprehensive development of clinical trial protocols for medicinal and device product development.
Regulatory Submissions
Comprehensive range of regulatory services for sponsors of all sizes, covering strategic planning, regulatory interactions, document preparation, and electronic submissions.
Clinical Trial Management
Comprehensive clinical research organization services providing medical expert and clinical trial management and auditing services to pharmaceutical, device, nutritional supplement, and botanical companies.
3rd Party Contract Management
Clintract delivers beginning-to-end clinical logistics and 3rd party management by lowering costs and improving compliance and efficiency in all aspects of angiotensin and clinical trial processes.
Informed Consent Form Development
Professional services for writing and developing ICH and GCP compliant Informed Consent Forms for clinical trials.
Consulting Services
Expert consulting services for medicinal and device product development.
Clinical Trial Protocol Development
Comprehensive development of clinical trial protocols for medicinal and device product development.
Regulatory Submissions
Comprehensive range of regulatory services for sponsors of all sizes, covering strategic planning, regulatory interactions, document preparation, and electronic submissions.
Services
Program and project management services covering Phase I through Phase IV/post-marketing clinical studies, including global site and patient recruitment coordination and study oversight.
Site selection and monitoring services including source document review, eligibility confirmation, compliance monitoring, and regulatory documentation maintenance.
Preparation of regulatory and clinical documents (protocols, clinical study reports, investigator brochures, integrated summaries, safety reports, manuscripts, and publication materials) with options for dedicated functional outsourcing teams.
Regulatory planning and dossier preparation for drugs, biologics, botanicals and devices with electronic submission support (eCTD, structured product labeling, electronic publishing) and regulatory project management.
Recruitment campaigns and retention programs for Phase IIb–III studies using social media, community outreach, central screening, advertising, and reporting/metrics systems.
Rapid identification and qualification of investigators and sites, training on protocol and technology tools (EDC and safety systems), and ongoing site performance oversight.
Program and project management services covering Phase I through Phase IV/post-marketing clinical studies, including global site and patient recruitment coordination and study oversight.
Site selection and monitoring services including source document review, eligibility confirmation, compliance monitoring, and regulatory documentation maintenance.
Preparation of regulatory and clinical documents (protocols, clinical study reports, investigator brochures, integrated summaries, safety reports, manuscripts, and publication materials) with options for dedicated functional outsourcing teams.
Regulatory planning and dossier preparation for drugs, biologics, botanicals and devices with electronic submission support (eCTD, structured product labeling, electronic publishing) and regulatory project management.
Recruitment campaigns and retention programs for Phase IIb–III studies using social media, community outreach, central screening, advertising, and reporting/metrics systems.
Rapid identification and qualification of investigators and sites, training on protocol and technology tools (EDC and safety systems), and ongoing site performance oversight.
Expertise Areas
- Clinical trial management
- Clinical monitoring and site management
- Protocol and informed consent development
- Patient recruitment and retention
Key Technologies
- Electronic Common Technical Document (eCTD) with XML metadata
- Electronic Data Capture (EDC)
- Online reporting and tracking tools for enrollment metrics
- Supply chain and clinical logistics technologies