Clinical Research

Develop clinical strategy from pre-market to post-market studies, including clinical evaluation plans, study protocols, and clinical evaluation reports.

Manage all aspects of site activities, from feasibility and selection to initiation, monitoring, and closure.

Provide clinical project management, including comprehensive budget oversight.

Ensure patient-centric study design and execution by identifying patient groups, aligning protocols with standards of care, including relevant endpoints, engaging patients, and supporting site selection and enrollment.

Facilitate effective collaboration with healthcare professionals through KOL identification, contract management, engagement, conference mapping, and full management of study committees and data safety monitoring boards.

What sets us apart is our integration of clinical study strategy with usability engineering for medical devices, ensuring a strong connection between clinical evidence, device safety, and effectiveness.

Deliver standard operating procedures, templates, Good Clinical Practice training per ICH-GCP E6 and ISO 14155, and provide coaching to support clinical staff development.

Support efficient outsourcing by assisting with sourcing models, vendor selection, CRO management, troubleshooting, vendor oversight, and clinical staffing.

Supply experienced clinical research professionals, including project managers, CRAs, and clinical trial assistants, to support your start-up company.