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title: Is Your Trial Stuck?
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From data verification to patient recruitment to NDA re-submission here are key resources to keep your trial moving forward

| View in browser Overcoming an NDA Refusal to File Your teams have worked hard to meet your NDA timeline and complete your submission to the FDA only to receive a Refuse to File letter. In response, we stepped in to perform an independent statistical review, explain findings to the FDA, and fixed data so the sponsor could re-submit the NDA to the FDA. Read More Rescue Recruitment for a Lagging Trial An ongoing safety study is struggling to meet its patient recruitment goals. Through site engagement techniques, more patients were recruited in 66% less time to meet study goals.  Read more Keeping Up with an Over-Performing Site A high volume of recruitment for a single site, numerous protocol amendments, and the continuous evolution of the project parameters leaves a sponsor overwhelmed. Learn how consistent monitoring with data verification and review get this trial on track. Read more Considering an Expedited Pathway? Our regulatory experts created this guide to highlight the benefits of, qualifying criteria for, and timing and procedures for six different expedited programs and designations. Click below to learn more. Read more Launch of a Phase I Vaccine Trial Veristat was asked to help a current client kick-off a phase I COVID-19 vaccine trial. The sponsor had identified sites and patients. The gating factor was to get the clinical trial database built quickly in order to start enrollment and randomization.   Read more       CONTACT US VERISTAT.COM Veristat, 134 Turnpike Road, Suite 200, Southborough, MA 01772 Manage preferences |
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