Clinical Trial Design and Execution

Our experienced team of professionals collaborates closely with you to design and execute clinical trials that meet regulatory requirements and address your specific research objectives. From protocol development to patient recruitment, site selection, and monitoring, we provide comprehensive support at every stage of the clinical trial process. 

Data Management and Statistical Analysis

ProCaliber Group offers comprehensive data management services, including data collection, validation, cleaning, and analysis. We also ensure data privacy and security throughout the process, adhering to industry standards and regulations.

Project Management

Our dedicated project management team works closely with you to develop project plans, define timelines, allocate resources, and monitor progress. We employ proven project management methodologies to ensure effective communication, coordination, and risk mitigation.

Regulatory Compliance

ProCaliber Group partners with the experienced regulatory agencies and leading regulatory firms provide invaluable guidance to ensure compliance with relevant regulations and guidelines. We assist in preparing regulatory submissions like FDA 510(k), PMA, interacting with regulatory authorities, and managing the regulatory approval process.

Quality Assurance and Auditing

Our experts conduct audits, identify areas of improvement, and assist in implementing corrective and preventive actions. With our rigorous quality assurance practices, you can enhance compliance, minimize risks, and foster a culture of continuous improvement.

Training and Education

We offer training programs and educational resources to help clients understand and navigate the US regulatory landscape, health system, quality requirements, and best practices in IVD development and commercialization.