Clinexa Life Sciences
Clinexa is a clinical research organization dedicated to accelerating research and impacting lives through efficient, high-quality, and compliant clinical trial solutions. With over 12 years of experience, Clinexa offers a range of services including strategic consulting, clinical trial management, site management, medical writing, and regulatory consulting. The company emphasizes personalized, competent, proactive, and convenient services to its clients, supporting a diverse portfolio of clinical trials across multiple therapeutic areas and phases. Clinexa's mission is to provide innovative and cost-effective solutions, leveraging deep expertise and a collaborative approach to ensure successful outcomes in clinical development.
Industries
Nr. of Employees
small (1-50)
Clinexa Life Sciences
Services
Full-service clinical trial operations from feasibility to close-out for Phase I–IV studies, including monitoring, site management and project oversight.
Program strategy, study planning, protocol development and regulatory advice for clinical development programs.
Regulatory planning, submission preparation and agency interaction support for multiple jurisdictions and product types (drugs, devices, biologics).
EDC study setup, eCRF design, database build and validation, edit checks, medical coding, data cleaning and database lock.
Safety oversight for clinical trials and marketed products including SAE review, coding, causality assessment, safety narratives and PSUR/DSUR preparation.
Preparation of pre- and post-submission regulatory documents, clinical study reports, integrated summaries, manuscripts, abstracts and educational materials.
Full-service clinical trial operations from feasibility to close-out for Phase I–IV studies, including monitoring, site management and project oversight.
Program strategy, study planning, protocol development and regulatory advice for clinical development programs.
Regulatory planning, submission preparation and agency interaction support for multiple jurisdictions and product types (drugs, devices, biologics).
EDC study setup, eCRF design, database build and validation, edit checks, medical coding, data cleaning and database lock.
Safety oversight for clinical trials and marketed products including SAE review, coding, causality assessment, safety narratives and PSUR/DSUR preparation.
Preparation of pre- and post-submission regulatory documents, clinical study reports, integrated summaries, manuscripts, abstracts and educational materials.
Expertise Areas
- Clinical trial management (Phase I–IV)
- Early clinical development and Phase I operations
- Regulatory strategy and global submissions
- Pharmacovigilance and safety monitoring
Key Technologies
- Clinical Trial Management Systems (CTMS)
- Electronic Data Capture (EDC) and eCRF design
- ePRO solutions
- Clinical database build, simulation and validation