Niche Service Providers Alliance Offers New Outsourcing Model
The alliance’s primary goal is to be flexible and adaptive based on client needs, while mitigating client risk, driving efficiency and improving timelines, and removing barriers that prevent getting treatments to market in a timely fashion.
A consortium of clinical trial management experts has formed to provide an alternative outsourcing solution for the pharmaceutical, biotech, and medical device industries. The alliance will leverage the strengths of each member organization, which deliver expertise across all functional areas that comprise the R&D organization.
Clients will be provided one point of contact. That contact--functioning as a project manager/director--will oversee all member companies to ensure the project is seamlessly executed and providing full transparency to the client, as needed.
Contractually, clients will receive one proposal and one contract for their project, minimizing the management of multiple vendors. Additionally, the client would only receive one invoice, with consortium members working on the financials on the back end.
The alliance’s primary goal is to be flexible and adaptive based on client needs, while mitigating client risk, driving efficiency and improving timelines, and removing barriers that prevent getting treatments to market in a timely fashion.
Companies that comprise this consortium to date include Clincierge, FMD K&L, InSeption Group, LLC, OneSource Regulatory, LLC, and Pyxa Solutions, LLC with room to grow. Contact jarcangelo@inseptiongroup.com to learn more.
Read the full release.
Moderna’s mRNA-1010 Flu Vaccine Meets Efficacy Goals in Phase III Trial of Adults 50+
July 10th 2025In the P304 Phase III study, Moderna’s mRNA-1010 demonstrated a 26.6% relative efficacy over a standard-dose flu vaccine in adults aged 50+, showing consistent protection across strains and age groups.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.
