Veristat can provide its regulatory submission expertise both in the US and abroad. We can assist you in achieving regulatory approval with our team of experienced medical writers and strategic consultants.
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.
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.
Veristat's hematology experience spans clinical development consulting, full clinical trial oversight, and regulatory submission preparation for rare genetic blood disorders and autoimmune blood diseases as well as blood cancers.
A poster presented by Gillian Birnie, Senior Director of Corporate Compliance
at the Society of Quailty Assurance (SQA) Annual Meeting 2018.
Implementing an electronic Trial Master File (eTMF) isn’t as simple as it sounds.
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.
Infectious Diseases have a global presence that has evolved with humanity for centuries. For many of these diseases, if they are not controlled, they will turn lethal.
Read more about our experience in infectious disease trials, and how Veristat can support you in your next clinical trial.
In 2010, the FDA published a draft guidance on how to conduct an adaptive designs clinical trial. In 2016, a final guidance was published on a similar topic, while also emphasizing the FDA's support for using adaptive designs for clinical trials.
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.