Comply with protocol and regulatory requirements.

Lotus Clinical Research’s quality management team supports our internal teams and clients with the production of documents that comply with protocol and regulatory requirements. Our quality operations management supports the preparation of procedures, reports, and/or training materials that help safeguard study participants.

Our team provides study recommendations and improvements that support the safest and most efficient means of conducting trials while maintaining compliance with all local and regulatory guidelines. For multicenter studies, Lotus Clinical Research quality operations management can utilize a team of highly experienced auditing professionals to conduct GCP-focused site audits to confirm site compliance to the protocol and federal regulations.