Monthly Archives: August 2023

Amidst discussions regarding quality control and software, it is crucial to remember the ultimate objective of this effort: the creation of a Registration Dossier ensuring that the data generated during the different stages of the lifecycle of the product are accurate, complete, and reliable.

Psychedelics, often associated with “magic” mushrooms, are gathering attention, and for good reason. Psychedelics’ potential treatment areas include a long list of illnesses that currently have high disease burdens, and some without any good current treatment options when first-line treatments fail.

If “life is what happens when you’re busy making other plans,” in the clinical research field, the corollary could be that “decentralized clinical trials are what happen while the industry is busy clarifying guidance for them.”

Trial participation for a patient with a rare disease that has significant medical needs, as in the case of Dravet syndrome, can be challenging and adds to the already overwhelming caregiver burden on parents. An organized, informed, and connected patient community can ease some of these challenges.

Identifying eligible patients, obtaining consent, executing the study, capturing data, and complying with all reporting and regulatory obligations take time and vital resources away from other important responsibilities at study sites. That’s where new clinical research technology comes in.