• Site Selection, feasibility analysis, rapid site identification, and recommendation;
• Ensuring that Investigators and Study Coordinators are trained on GCP, SOPs and study protocol;
• Quick and efficient Clinical Study Start up with prompt "right first time" document completion process;
• Rapid Contract negotiation and completion;
• Timely and centralized regulatory submissions;
• Generate study specific source documents, worksheets and study material development;
• Site setup and study specific equipment placement to comply with protocol and ICH-GCP;
• Quality assurance system: errors prevention and site troubleshooting in the early study stage;
• Chart review.
• Timely patient recruitment, enrolment and retention;
• Efficient data collection, timely data entry and query resolution;
• Document retention according to regulations and GCP / SOPs;
• Investigator Site File maintenance;
• Management of study supplies in compliance with the Protocol;
• IP receipt, secure storage, administration, accountability and destruction;
• Performance of study activities and procedures according to the Protocol;
• Continuity of staff with minimal turnover;
• Encouragement of active participation of Investigator in the study events;
• Ongoing communication with Sponsor or CRO;
• Provision of adequate space and tools for CRA on site during monitoring visits;
• Adequate research amenities on/off site;
• Investigator/staff ongoing training according to protocol amendments;
• Centralized and site-specific advertising and media creation, placement and metrics.
• CTMS sites are committed to meet database lock deadlines;
• Final IP accountability and return in collaboration with CRA per protocol requirements;
• Post study patient follow up per protocol (if applicable);
• Final report to IRB, Sponsor, Health Canada and FDA (if applicable);
• Trials documentation archiving according to Regulation, ICH-GCP and SOP.
• Multilingual study coordinators/research RNs;
• Mobile research RN services – enhancing patient recruitment and retention by GCP-compliant services by conducting selected study visits in home or other convenient locations for patients (if approval is granted);
• Patient Recruitment Services - subject enrollment support for Non-CTMS network sites in early and late phase of enrollment period;
• Site Management for Non-CTMS network sites;
• Staff training – CTMS supports investigators, staff and trainees who conduct clinical research, and provides advice, support, materials and resources for all types of clinical research studies. CTMS also provides an orientation program for new clinical research staff including a training manual, and various educational and professional development opportunities;
• Study team planning and placement/hiring;
• Regulatory Submission Support (Site level) for Non-CTMS network sites - assist you in preparing and submitting your regulatory application, ensuring compliance with all regulatory agency technical requirements so that your submission will swiftly pass technical validation and arrive to the reviewers without delay;
• Operational Support for Non-CTMS network sites;
• Independent Monitoring and audit/inspection preparation for Non-CTMS network sites;
• Strategy and consultation for Non-CTMS network sites.
