SMO

Our project managers take ownership of the project and serve as a single point of contact between the sponsor, sites and vendors.

Our clinical data management team has extensive experience in handling both paper CRFs and EDC- based data management projects. We use a comprehensive 21 CFR Part 11 compliant, commercially available and user friendly data management system.

Adhering to our streamline process allows us to meet enrollment commitments for your study. We identify the best sites through in-depth research and feasibility.

Our clinical quality management team will ensure your study withstands regulatory scrutiny and adheres to FDA Good Clinical Practice compliance guidelines from study inception to database lock.

RCRM’s clinical trial management services are supported by a highly qualified team of diagnostic and medical device experts. Our expertise in managing both domestic and international clinical trials from beginning to end sets the foundation of a lineup of industry-leading services. We will fully manage and provide great assistance for every phase of your clinical trial

• Study and protocol design and review
• Case report form (CRF) design and development
• Informed consent development and review
• Clinical investigator evaluation, qualification and selection
• Clinical trial management and coordination
• Selection, training and management of therapeutically qualified Clinical Research coordinators(CRC’s) and Clinical Research Associate (CRAs)
• Trial Master File (TMF) creation and management
• Ethics Committee (EC) submission
• Medical and safety monitoring
• Database development and management
• Project Management and Operation
• Feasibility assessment and site selection
• ICH-GCP training
• Archival area document retention