Regulatory Affairs

Regulatory Compliance: CARU specializes in navigating the regulatory landscape of Central America, ensuring compliance with local regulations and international standards for clinical research.

Documentation Support: We provide comprehensive documentation support, assisting clients in preparing and submitting regulatory documents required for clinical trial approval in Central American countries. This includes managing the submissions of protocols and other necessary documents optimizing timelines and minimizing regulatory hurdles to expedite approval processes.

Ongoing Compliance Monitoring: CARU conducts ongoing compliance monitoring throughout the duration of the trial, ensuring that all regulatory requirements are met and maintained. We handle all submissions and regulatory interactions on behalf of our clients, providing a seamless and efficient regulatory affairs service.

Site Management

Comprehensive Oversight: CARU provides comprehensive site management services tailored to the specific requirements of each clinical trial conducted in Central America.

Efficient Operations: Leveraging our expertise and experience, we ensure efficient and effective operations at every research site, optimizing processes to streamline trial execution.

Dedicated Support: Our team offers dedicated support to site staff, providing training, guidance, and resources to facilitate smooth trial implementation and adherence to protocols.

Continuous Monitoring: We conduct rigorous monitoring and oversight throughout the duration of the trial, ensuring compliance with regulatory requirements, data accuracy, and patient safety.

Clinical Trial Management

Strategic Planning: CARU offers strategic planning services to ensure that clinical trials conducted in Central America are carefully designed and executed to meet the objectives of our clients.

Comprehensive Execution: We provide comprehensive execution of clinical trials, overseeing all aspects of trial management including site selection, patient recruitment, data collection, and regulatory compliance.

Quality Assurance: Our team implements rigorous quality assurance measures to maintain the integrity of the trial data and ensure adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements.

Timely Reporting: CARU ensures timely reporting of trial progress and outcomes to our clients, keeping them informed and updated throughout the duration of the trial.

Budget management: in CARU We efficiently manage financial resources in clinical trials, following the best practices in budget management in clinical research, we develop strategies to maximize return of investment and we are focused on the importance of transparency and accountability in budget management.

Clinical Data management

Comprehensive Data Solutions: CARU offers comprehensive clinical data management solutions tailored to the unique needs of clinical trials conducted in Central America.

Data Collection and Validation: We manage the collection, validation, and processing of clinical trial data, ensuring accuracy, completeness, and compliance with the protocol.

Quality Assurance: CARU implements rigorous quality assurance measures to maintain the integrity of the trial data, conducting regular data audits and validations to ensure data quality and reliability.