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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 development...

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1 min read

Planning the Way Forward for a New Tumor Evaluation Modality

RECIST (Response Evaluation Criteria in Solid Tumors) guidelines were introduced over twenty years ago to provide a standard for evaluating tumor response, with the goal of maintaining consistency at sites and across sites as well as limiting any site...

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4 min read

Regulatory Guidance Monthly Review - July 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 development...

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1 min read

Turning an SPA rejection into BLA Submission Success

Veristat supported a Sponsor from SPA rejection to BLA submission, bringing strategic expertise to a small client team tackling their first clinical stage program for a novel ophthalmic therapy.

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4 min read

Regulatory Guidance Monthly Review - June 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...

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1 min read

On-Demand Webinar: Natural History Study for Ultra-Rare Diseases

Were you able to join Veristat’s live webinar- “Strategies for Solving the Challenges of an Extraordinary Natural History Study – Navigating the Patient Experience When Pivoting to a Virtual Model Mid-Study”? 

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5 min read

Regulatory Guidance Monthly Review - May 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...

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2 min read

Regulatory TOPRA Webinar: Latest Regulatory Experiences

Each year, Veristat regulatory experts present timely, relevant topics to members of The Organization for Professionals in Regulatory Affairs (TOPRA), a UK-based organization committed to driving regulatory excellence across the healthcare regulatory...

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3 min read

Joining HIPRA to Take Aim at the Continuing Challenges of COVID-19

UPDATE – Veristat study collaboration with HIPRA leads to EMA approval of BIMERVAX® COVID-19 vaccine, the first bivalent recombinant protein vaccine to be authorized in the EU and the first human health vaccine to be designed and developed in Spain.

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2 min read

The New EU Framework for In Vitro Diagnostics Enters into Application

The In Vitro Diagnostics Regulation (IVDR, EU 2017/746) enters into application in the European Union (EU) on 26 May 2022.

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