KlinEra Global Services
KlinEra stands for a New Era in Clinical trials using cutting-edge, AI-Based technology to expedite recruitment and minimise time to market. Established in 2005, KlinEra provides innovative, customized clinical trial and research services to conduct ethical and efficient clinical trials that will accelerate delivery of novel therapeutic treatments with faster patient access. The company has extensive experience in various therapeutic areas, maintains high regulatory standards, and has a global presence enabling it to perform clinical trials worldwide. KlinEra's mission includes advancing clinical research through technology, fostering community and educational programs, and maintaining high standards of regulatory compliance and quality assurance.
Industries
Nr. of Employees
medium (51-250)
KlinEra Global Services
San Jose, California, United States, North America
Services
End-to-end clinical operations support across Phase I–IV, including site selection, enrollment, monitoring, retention and study conduct.
Program and project management for clinical studies, coordinating cross-functional teams and timelines.
Regulatory support and advisory services with experience across major regulatory authorities for submission strategy and compliance.
Quality systems support and audit services to ensure compliance and readiness for global audits.
Comprehensive data services including EDC development, data cleaning, medical coding, CDISC standardization and biostatistical support for design and analysis.
Safety monitoring and pharmacovigilance support during clinical development.
End-to-end clinical operations support across Phase I–IV, including site selection, enrollment, monitoring, retention and study conduct.
Program and project management for clinical studies, coordinating cross-functional teams and timelines.
Regulatory support and advisory services with experience across major regulatory authorities for submission strategy and compliance.
Quality systems support and audit services to ensure compliance and readiness for global audits.
Comprehensive data services including EDC development, data cleaning, medical coding, CDISC standardization and biostatistical support for design and analysis.
Safety monitoring and pharmacovigilance support during clinical development.
Expertise Areas
- Clinical trial management (Phase I–IV)
- Site identification, feasibility and monitoring
- Project management for clinical programs
- Regulatory compliance and submissions (DCGI/USFDA/EMA)
Key Technologies
- Electronic data capture (EDC)
- Clinical trial management systems (CTMS)
- Electronic trial master file (eTMF)
- IVRS/IWRS and web-based randomization systems
News & Updates
KlinEra Case Study
A detailed case study showcasing KlinEra’s approach and success in clinical trials.
KlinEra Community Services
Information about KlinEra’s community health and educational programs.
KlinEra Advantage
Highlights of KlinEra’s unique benefits and service offerings.
KlinEra’s Innovative Approach to Clinical Trials
An article discussing how KlinEra leverages technology and expertise to expedite clinical research.
Expanding Global Reach in Clinical Research
Details on KlinEra’s global operations and regulatory expertise.
KlinEra’s Community and Educational Initiatives
Coverage of KlinEra’s CSR activities including KlinEducate and community clinics.
KlinEra Case Study
A detailed case study showcasing KlinEra’s approach and success in clinical trials.
KlinEra Community Services
Information about KlinEra’s community health and educational programs.
KlinEra Advantage
Highlights of KlinEra’s unique benefits and service offerings.
KlinEra’s Innovative Approach to Clinical Trials
An article discussing how KlinEra leverages technology and expertise to expedite clinical research.
Expanding Global Reach in Clinical Research
Details on KlinEra’s global operations and regulatory expertise.
KlinEra’s Community and Educational Initiatives
Coverage of KlinEra’s CSR activities including KlinEducate and community clinics.