Stabilize now. Recover fast.
Recovery of an at-risk study begins with an accurate assessment of its current condition and the remediation required. Alethium evaluates the study as it stands, ranks findings by regulatory risk, and delivers a validated path forward without restarting the trial.
No-Cost Assessment
Alethium reviews the study as it stands: data, documentation, systems, and vendor performance, then reports its findings.
Risk-Ranked Findings
Findings are ranked by impact on participant safety, data integrity, regulatory compliance, and timelines, distinguishing issues that threaten the submission from those that do not.
Data Remediation
Our data managers reconstruct provenance, resolve query backlogs, and bring datasets back to a state that survives regulatory review, including data captured in systems we did not build.
Documentation Recovery
Essential documents and the trial master file rebuilt and reconciled, with gaps identified and closed before an audit finds them.
Mid-Study Transition
When a change of CRO is the right answer, our team executes the transition without pausing the study. Site relationships, data, documentation, and vendor contracts transfer under a documented plan.
Enrollment Recovery
Stalled enrollment addressed at its source, whether that is protocol burden, site performance, or a recruitment approach that never reached the right participants.
Forward on Alethium
Studies that transition to Alethium continue on our Clinical Data Platform, where every subsequent action is captured as immutable evidence. Studies that stay where they are get the remediation plan regardless.
Retrospective Assessment
For completed studies facing questions, our team reconstructs what happened and documents it, which is often needed before a submission, a partner's diligence, or a regulatory inquiry.
Assessed. Stabilized. Recovered.
A no-cost assessment and a validated path forward.
FAQs - Common Questions
Rescue is taking over or repairing a study already in progress that is failing on data quality, enrollment, compliance, or vendor performance. Alethium assesses the study as it stands, ranks the problems by regulatory risk, and delivers a remediation plan — without restarting the trial.
Our team reviews study data, documentation, systems, and vendor performance, then reports what is broken and ranks findings by impact on participant safety, data integrity, compliance, and timelines. You receive the findings and the recommended path forward with no obligation to engage Alethium further.
Yes. Retrospective assessments reconstruct and document what happened during a completed study, which is often needed before a submission, during partner diligence, or in response to a regulatory inquiry.
Yes, and it is more common than sponsors expect. The risk is not the change itself but an undocumented handover. Alethium executes mid-study transitions under a documented plan covering data, essential documents, site relationships, and vendor contracts, so continuity holds and the transition itself withstands regulatory review.
Yes. Remediation routinely involves data from systems Alethium did not build — legacy platforms, sponsor-owned EDC, or another CRO's environment. Our data managers reconstruct provenance, resolve query backlogs, and restore datasets to a submission-ready state.
Rescue engagements start with the assessment, which begins as soon as we have access to the study record. Because our team runs the full range of trial services, remediation can begin immediately after findings rather than waiting on a second vendor to be contracted.
