From site identification to closeout
Startup timelines and data quality are determined largely by site selection. Alethium selects sites on demonstrated performance, activates them through parallel workstreams, and directs monitoring effort according to risk: centralized review by default, on-site visits when risk indicators warrant them.
Site Operations
In a hybrid protocol, sites carry only the procedures that require them. How those sites are chosen, activated, and supported is what determines whether startup takes weeks or months.
Site Identification & Feasibility
Sites evaluated on demonstrated enrollment in the relevant population, staff capacity, and equipment, rather than on prior relationships. Feasibility findings feed the protocol before it locks.
Site Activation
Contracts, budgets, regulatory packets, and training executed in parallel rather than in sequence, with activation status visible to everyone at once. Sites go live when their requirements are met, not when a monthly report catches up.
Site Training & Support
Protocol and system training delivered and documented, with completion tracked to the individual and to the version of the protocol trained on. Our team supports site staff directly so questions do not become deviations.
Risk-Based Monitoring
Monitoring effort follows the critical-to-quality factors identified at design. Sites and data points that carry real risk get attention; those that do not are not monitored into submission.
Centralized Review
Our monitors review data continuously from the study record rather than waiting for a visit. Enrollment anomalies, protocol deviations, and outlier patterns surface as they occur, and trigger action rather than a note in a report.
Deviation Prevention
Most deviations are prevented rather than caught. Consent status, eligibility, and visit windows are verified automatically before study activity proceeds, so the error never reaches the record.
Closeout
Site closeout executed against a documented checklist: supplies reconciled and returned, records complete, essential documents filed, with each step verifiable in the study record.
Fewer deviations, faster startup, oversight where the risk is.
FAQs - Common Questions
Sites are evaluated on demonstrated enrollment in the relevant population, staff capacity, equipment, and regulatory standing — evidence rather than familiarity. Feasibility findings are fed back into protocol design before it locks, so eligibility criteria and visit schedules reflect what sites can actually execute.
Both, with centralized remote review as the default. Our monitors work continuously from the study record, so anomalies surface as they occur. On-site visits are triggered by risk signal rather than a fixed calendar, and the monitor arrives with the specific findings that prompted the visit.
Most deviations are prevented rather than detected. Consent status, eligibility, and visit windows are verified automatically before study activity proceeds, so an unconsented participant cannot be dosed and an out-of-window visit is flagged before it happens. Deviations that do occur are captured with full context for rapid resolution.
Risk-based monitoring concentrates oversight where risk to participant safety and data integrity is highest, rather than applying uniform source data verification everywhere. Under ICH E6, this is the expected approach. Alethium identifies critical-to-quality factors during design and directs monitoring effort accordingly.
Activation steps — contracts, budgets, regulatory packets, and training — run in parallel rather than sequentially, and status is visible to every party in real time. A site goes live when its requirements are met rather than when a status report circulates.
Yes. Monitoring can be engaged independently, including for studies conducted on a sponsor's own EDC or another CRO's platform. (See Rescue Services for studies already at risk.)