Monitoring

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We have a vast understanding and training of GCPs in accordance with regulations.

Our monitors are specialists in the unique requirements associated with medical device research. Our CRAs have 10+ years experience in Ophthalmology and on average more than 25 years of monitoring experience. They ensure sponsors and PMs are kept in the loop at all times.

Sierra believes in building strong relationships with clinical sites to ensure a site's commitment to a study. We lend a hand to site staff and coordinators by providing assistance and additional study training when needed, resolving study issues efficiently, and guiding site staff throughout the course of every trial from startup to close-out.

In-depth level monitoring while balancing precision and efficiency is our specialty. This ensures the clinical data captured represents high accuracy and completeness. 100% source document verification (SDV) is performed by comparison of subject source documents and clinic charts to data entered into the EDC system. Monitors utilize EDC tools to quickly identify records requiring SDV and queries needing resolution.

Comprehensive regulatory document review is performed routinely during visits to ensure compliance with the protocol and regulations.

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Our Monitoring services include:

Site qualification visits (SQV) Site initiation visits (SIV) & training On-site Interim monitoring visits (IMV) Remote monitoring visits (rIMV) 100% Source document verification (SDV) Ensure protocol compliance Source document verification (SDV)

Query resolution Review & collect study regulatory documentation Monitoring reports Manage study sites Provide ongoing site staff training Close-out visits (COV)

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Our Study Support services include:

eTMF Setup Regulatory document review & tracking eTMF Management Periodic regulatory doc audits Issue postop visit schedules per subject

Study materials management & distribution Assembly of study materials Study archiving

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