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Conducting Quantitative Risk Assessments for Anonymized Datasets and Documents: What This Means for Sponsors and Patient Privacy

Conducting Quantitative Risk Assessments for Anonymized Datasets and Documents: What This Means for Sponsors and Patient Privacy

by Olivia Grant | Oct 3, 2022 | Blog

CANTON, Mich. (10/2/2022) – Data anonymization and document anonymization in clinical trial data is now more important than ever. In recent years, clinical trial data sharing has become a requirement as part of the regulatory process for EMA and Health Canada. ...
New FDA Guidance to Support Ultra-Rare Disease Drug Development

New FDA Guidance to Support Ultra-Rare Disease Drug Development

by Olivia Grant | Jan 10, 2022 | Blog

Antisense oligonucleotide (ASO) drug products target a specific sense mRNA to modulate gene expression in living cells and have been used successfully to treat diseases where the pathogenic mutation has been identified.    For patients with an...
Praxis bioresearch seeks support from MMS for Alzheimers Disease Therapeutics

Praxis bioresearch seeks support from MMS for Alzheimers Disease Therapeutics

by Olivia Grant | Oct 28, 2021 | News

SACRAMENTO, Calif. (October 28, 2021) – MMS Holdings (MMS) – a data-focused CRO – provided regulatory strategy support to Praxis Bioresearch in the development of a therapeutic for apathy in Alzheimer’s disease. This comes as Praxis was awarded a $2.9 Million...

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