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Genentech GO27912 500 Linden Oaks, 2 nd Floor Rochester, New York 14625 (585) 249-6231 www.virtualscopics.com NASDAQ: VSCP 1.

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Presentation on theme: "Genentech GO27912 500 Linden Oaks, 2 nd Floor Rochester, New York 14625 (585) 249-6231 www.virtualscopics.com NASDAQ: VSCP 1."— Presentation transcript:

1 Genentech GO27912 500 Linden Oaks, 2 nd Floor Rochester, New York 14625 (585) 249-6231 www.virtualscopics.com NASDAQ: VSCP 1

2 2 Scanning Requirements: Screening: MRI scans of the brain and CT scans of the chest, abdomen and pelvis at Baseline. MRI scans of the brain and CT scans of the chest, abdomen and pelvis at Baseline. A CT scan of the neck, or bone scan may be optional at Baseline (28 days before day 1 of cycle 1), at the discretion of the PI. A CT scan of the neck, or bone scan may be optional at Baseline (≤28 days before day 1 of cycle 1), at the discretion of the PI. Subsequent Scans: CT chest and abdomen scans (and pelvis at the discretion of the PI), CT chest and abdomen scans (and pelvis at the discretion of the PI), additional scans if requested by the PI, every 6 weeks after Cycle 1 Day 1 (Day 0) until disease progression or study completion. additional scans if requested by the PI, every 6 weeks after Cycle 1 Day 1 (Day 0) until disease progression or study completion.

3 Pre-Qualification – Site Questionnaire and Review – Pre-Qualification of equipment and imaging site personnel training are completed prior to the start of the patient imaging; on-going communication and feedback with site personnel continues throughout the study Initial Qualification – Site manuals provided before training link – Initial site qualification upon site personnel completing the training, completing and passing the quiz at the end of the training – Sites must pass initial qualification before scanning study patients Final Qualification – VirtualScopics’ review and quality inspection of first patient data set – Copies of technologist signature log and binder receipt documents 3

4 Self-paced, web-based training is provided to each site: – Remote training via Training Campus – sites can click on the link to conduct training when the time is best for the site Training covers: – Review of the imaging site study requirements – Technologist certification to image study patients – Proper study patient identification, GCP – Review of the study specific imaging parameters – Review of data submission procedures – Quality control and quality assurance – Questions Lead technologist and person responsible for data submission must complete training. Others may also complete the training. 4

5 Sites will be requested to send images within 2 days of imaging. AG Mednet Electronic Image Transfer Services will be utilized to provide electronic image transfer services from the sites to VirtualScopics. Images can also be submitted via CD or sFTP Images will be accompanied by Data Transmittal Form (DTF) 5


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