CroxxMed
CroxxMed has over 20 years of experience in clinical research, providing professional and dedicated services to bring products to market efficiently. They focus on quality, trust, and long-term relationships with clients, emphasizing close collaboration and understanding client needs.
Industries
Nr. of Employees
small (1-50)
Products
Data Management & Statistics
Processing of reliable high-quality data through statisticians and data managers involved from early planning to final closing.
Trial-on-Line
An efficient and fully 21CFR Part 11 compliant and validated eCRF solution used for clinical trial data management.
Safety Services
Pharmacovigilance and clinical trial safety services including case processing, medical evaluation, safety data submission to regulatory authorities, and periodic report preparation.
Project Management
Comprehensive clinical trial project management services encompassing initiating, planning, executing, monitoring/controlling, and closing.
Regulatory Affairs
Regulatory affairs services bridging the industry and Competent Authorities/Ethics committees, including consultation, liaison, clinical trial authorization applications, CE mark documentation, and pharmaceutical documentation support.
Clinical Operation
Expertise, accuracy, and speed in clinical operations to help drugs get to market as fast as possible.
Data Management & Statistics
Processing of reliable high-quality data through statisticians and data managers involved from early planning to final closing.
Trial-on-Line
An efficient and fully 21CFR Part 11 compliant and validated eCRF solution used for clinical trial data management.
Safety Services
Pharmacovigilance and clinical trial safety services including case processing, medical evaluation, safety data submission to regulatory authorities, and periodic report preparation.
Project Management
Comprehensive clinical trial project management services encompassing initiating, planning, executing, monitoring/controlling, and closing.
Regulatory Affairs
Regulatory affairs services bridging the industry and Competent Authorities/Ethics committees, including consultation, liaison, clinical trial authorization applications, CE mark documentation, and pharmaceutical documentation support.
Clinical Operation
Expertise, accuracy, and speed in clinical operations to help drugs get to market as fast as possible.
Services
Operational services for clinical trials across start-up, study conduct and close-out including feasibility, site selection and management, monitoring, recruitment planning, medical monitoring, data and safety oversight.
QA support including QMS design, SOP and template development, audit and inspection preparation, CAPA support and training management aligned with GCP/ICH.
Services covering database and CRF design (paper and electronic), validated EDC operation, data cleaning, database lock and transfer, statistical design and analysis, SAP preparation, and statistical programming.
Regulatory consulting and submission support including clinical trial authorizations, liaison with competent authorities and notified bodies, CE mark documentation, and country-specific regulatory guidance.
Project management services including protocol writing support, study team setup, vendor selection and oversight, site contract negotiation, project planning and risk management through study closure.
Safety and pharmacovigilance services including case processing, medical review, regulatory safety reporting, and preparation/submission of periodic safety reports.
Operational services for clinical trials across start-up, study conduct and close-out including feasibility, site selection and management, monitoring, recruitment planning, medical monitoring, data and safety oversight.
QA support including QMS design, SOP and template development, audit and inspection preparation, CAPA support and training management aligned with GCP/ICH.
Services covering database and CRF design (paper and electronic), validated EDC operation, data cleaning, database lock and transfer, statistical design and analysis, SAP preparation, and statistical programming.
Regulatory consulting and submission support including clinical trial authorizations, liaison with competent authorities and notified bodies, CE mark documentation, and country-specific regulatory guidance.
Project management services including protocol writing support, study team setup, vendor selection and oversight, site contract negotiation, project planning and risk management through study closure.
Safety and pharmacovigilance services including case processing, medical review, regulatory safety reporting, and preparation/submission of periodic safety reports.
Expertise Areas
- Clinical trial management
- Quality assurance and GCP/ICH compliance
- Clinical data management
- Biostatistics and statistical programming
Key Technologies
- Electronic data capture (EDC) / eCRF systems
- 21 CFR Part 11–compliant system validation
- Electronic Trial Master File (eTMF) systems
- SAS statistical programming