Imagine you are completing your regulatory submission project with only nine months left until submission day and you still have to migrate legacy data into SDTM format for 18 studies as well as 2 ongoing pivotal studies.
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When Veristat partnered with a US based biotechnology company on a Phase II study for a topical spray to treat hypertension, our emphasis on effective planning and management led to overwhelming success.
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A clinical stage biotech firm engaged Veristat to run their very first ever clinical trial, a phase I US only oncology trial. When the project started, the client was a three-person team. Veristat was and still is the entire project team and we have and continue to work with this client to guide them and train them through the clinical trial process.
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Patient recruitment delays are common challenges in clinical trials that can lead to costly delays. In fact, nearly 80 percent of patient recruitment timelines in clinical trials are not met and over 50 percent of the patients are not enrolled within the planned timeframes.
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Find out how Veristat was able to expertly rescue the site management and monitoring activities for a sponsor seven months into patient enrollment at the site by utilizing our adaptable project managers and monitoring services.
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Veristat has collaborated with biopharmaceutical firms on the preparation of over 50 INDs. Learn how we successfully helped a sponsor finalize their IND in under 6 weeks.
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Veristat's dynamic teams of regulatory experts and experienced medical writers are problem solvers that can guide you to regulatory approval.
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Veristat provides a feasibility assessment to a clinical stage biotechnology firm who wants to know whether it is feasible to expand their current US study into European sites. Being an oncology study, the trial had some very specific technology requirements for the site and part of the assessment was to determine if that technology was available at sites in Europe
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A biopharmaceutical firm specializing in rare and ultra-rare disease research started working with Veristat over 7 years ago.
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