Blog | Think Bold, Think Scientific, Think Veristat

Gain the latest insights and trends in clinical trials, patient recruitment, data analysis, adaptive design, regulatory submissions and approvals.

Sign Up Today

5 min read

Laying the Groundwork to Measure the Impact of Decentralized Clinical Trials (DCTs)

The Tufts CSDD Roundtable took place in November, and on behalf of Veristat, I was honored to participate in this invite-only program. It is part of our company’s DNA to stay ahead of the driving forces in the industry so that we can best serve as a...

READ MORE

2 min read

On-Demand Webinar: Orphan Drug Designation - The Considerations, The Rewards, and How They Differ Between The US and Europe

Did you know approximately 1 in 10 Americans are affected by a rare disease or condition according to the National Institutes of Health (NIH)? That’s 30 million people in the US, and similarly in the EU affected.Before 1983 in the US and 2000 in the EU,...

READ MORE

1 min read

Rolling Review mechanisms and CMAs (Conditional Marketing Authorisations) have made it possible to speed up the approval of treatments against Covid-19

GENESIS BIOMED recently interviewed Xavier Luria, former Head of Safety and Efficacy of Medicines at the European Medicines Agency (EMA), and now Veristat’s Vice President of Regulatory Affairs, Europe.

READ MORE

1 min read

Shortening Development and Approval Timelines for Novel Medicinal Products

The FDA and EMA offer expedited regulatory approval pathways to accelerate time-to-market for novel therapies intended to treat serious conditions and unmet medical needs. There are twelve special designations, many of which reduce clinical development...

READ MORE

4 min read

Marketing Application Publishing Best Practices

Effectively managing the publishing of documents required for a marketing application submission can help accelerate the time it takes to bring your product to market.  

READ MORE

4 min read

Autologous and Allogeneic Cell Therapies: Benefits, Challenges, and Future Prospects

Cell and gene therapies (CGT) are at the frontline of clinical research and offer the potential to transform treatment for serious medical conditions. There are two types of cell therapies in development – autologous and allogeneic. Each provides...

READ MORE

4 min read

Regulatory Guidance Monthly Review - September 2022

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA)  that are pertinent to the governance of clinical trials and drug, biologic, or medical device...

READ MORE

1 min read

Regulatory Publishing Expertise for an Efficient NDA Submission Process

Veristat supported a commercial stage biopharmaceutical company in NDA submission, bringing regulatory publishing expertise for a new therapy being developed for the acute treatment of schizophrenia or bipolar disorder-associated agitation. This...

READ MORE

1 min read

Early Development Challenges in IND Applications

There is much for companies to consider before submitting an investigational new drug (IND) application to FDA. Planning, collecting the appropriate data, and effectively communicating with regulatory bodies can all help companies overcome challenges in...

READ MORE

4 min read

Regulatory Guidance Monthly Review - August 2022

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA)  that are pertinent to the governance of clinical trials and drug, biologic, or medical device...

READ MORE