Safety Management

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We are laser focused on subject safety during clinical trials.

At Sierra, subject safety is the primary priority during the conduct of a study. Our team of highly experienced experts ensure proper safety oversight.

We create a safety management plan (SMP) detailing requirements and procedures for the processing and reporting of serious adverse events (SAEs) during trials. The SMP provides roles, responsibilities, processes and timelines for all safety related activities.

We leverage our technology tools to facilitate the safety oversight and review processes. All safety documentation will be tracked, filed, and readily available to our sponsors.

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Our Safety Management services include:

Development of safety management plan (SMP) Safety oversight during clinical trials Routine review of safety dashboard and reports Reconciliation of all AEs and SAEs Safety correspondence with sites, sponsor and medical monitor AE and SAE reconciliation in EDC database

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