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innovations during the drug
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Sprinting Towards the Finish Line – How FDA’s Breakthrough Devices Program Helps Sponsors Expedite their Development Programs
The Breakthrough Devices Program is a voluntary program for certain medical devices and ...
Providing Clinical Leadership for Early-Stage IO Biotech Companies
This content was originally published in Women Leadership in Immuno-Oncology Issue 2023. ...
How to Build Conflict-Resilient Clinical Trials
This Content is Part Two of a Three-Part Series A Case for Resiliency in Clinical Trials
Training in Clinical Trials: Secrets Separating the Best from the Rest
Content in collaboration with ScienceMedia Malachi Bierstein, Vice President of Global ...
Democratizing Clinical Trials – Bringing the Trial to the Patient
Over the past three years, physicians and caregivers are increasingly engaging with ...
Removing the Challenges Around Electronic Common Technical Documents
The Electronic Common Technical Documents (eCTD) is a harmonized solution to implement ...
Halloran Named Top 100 Women-Led Businesses in MA in 2022
Boston (November 1, 2022) – The Women’s Edge (formerly The Commonwealth Institute) ...
Preparing for ICH E6(R3) GCP When You’re Still Struggling with (R2)
The first version of the International Council for Harmonisation (ICH) E6 Good Clinical ...
When Clinical Decision Support Software is Considered a Medical Device
Pre-Guidance History
Regulatory CMC Experts Navigate Accelerated Approval Timelines
Picture this: a pharmaceutical company just received an accelerated approval designation ...