Pharmaron’s Post

When a 500-Patient Study for $36M is a Bargain: True Cost of a Clinical Trial Clinical trials are the most expensive component of the overall cost of developing a new drug but there is little agreement on what a given trial should cost. Last month, Doctors Without Borders reported that it cost them $36 million to complete a 552-patient multinational trial indicating that the cost of the trials should be... Read More: https://lnkd.in/gwxJHPSM Author: Mukesh Kumar, PhD, RAC, | CEO, FDAMAP #fda #clinicaltrial #clinicalstudies #clinicaldevelopment #clinicalresearch #drugs #fdaapproveddrug #fdaregulations #fdacompliance

Another #Onsemble gem! Frank Conte, VP of Strategic Partnerships at Advarra, shared invaluable insights into the FDA's proposed single IRB mandate and its impact on drug and device trials. Key Takeaways: 👏 Broad Impact: The FDA’s new mandate will universally apply to all FDA-regulated trials, significantly changing the current landscape. 🤔 Industry Preparedness: Research sites and sponsors need to reevaluate and adjust their processes in anticipation of the mandate. ✅ Advarra's Role: Advarra is gearing up to support the industry through this transition with webinars, resources, and expert guidance to navigate these changes effectively. #ClinicalResearch #FDARegulations

For over a decade, sponsors and researchers have talked about patient-centric drug development, yet clinical trials remain largely unchanged. To truly enhance patient experiences and improve health outcomes, we must move beyond small innovations and embrace a full-scale paradigm shift. https://gag.gl/wE0cVC #DrugDevelopment #FortreaConsulting John Doyle, Dr.P.H.

For over a decade, sponsors and researchers have talked about patient-centric drug development, yet clinical trials remain largely unchanged. To truly enhance patient experiences and improve health outcomes, we must move beyond small innovations and embrace a full-scale paradigm shift. https://gag.gl/wE0cVC #DrugDevelopment #FortreaConsulting John Doyle, Dr.P.H.

For over a decade, sponsors and researchers have talked about patient-centric drug development, yet clinical trials remain largely unchanged. To truly enhance patient experiences and improve health outcomes, we must move beyond small innovations and embrace a full-scale paradigm shift. https://gag.gl/wE0cVC #DrugDevelopment #FortreaConsulting John Doyle, Dr.P.H.

Continuing our Protas People series, this week’s spotlight is on William Hayes, our Drug Supply Manager 💊    William leads in the design and delivery of a drug supply plan that supports Protas’ mission of delivering efficient and impactful trials.    “It is such a privilege to work at a company that is full of people passionate about improving the landscape of clinical trials, where I can see the real-world impact of my work.”    Visit our website to read more about our mission and work: www.protas.co.uk     #ProtasPeople #LifeAtProtas #ClinicalTrials #SupplyChainManagement  

Accelerating First-In-Human (FIH) Studies with Precision and Efficiency. At Eric Solutions, we understand that timely and cost-effective execution of First-In-Human (FIH) studies is crucial for the success of your drug development program. Our U.S.-based capabilities are designed to deliver reliable results across diverse therapeutic areas, setting the foundation for your clinical milestones. Whether you are advancing a breakthrough therapy or exploring novel modalities, Eric Solutions is your partner in de-risking FIH studies and bringing innovations to life faster. Let’s connect to discuss how we can accelerate your next clinical milestone! #ClinicalTrials #FIHStudies #DrugDevelopment #EricSolutions #CROExcellence #VariedTherapeuticAreas

For over a decade, sponsors and researchers have talked about patient-centric drug development, yet clinical trials remain largely unchanged. To truly enhance patient experiences and improve health outcomes, we must move beyond small innovations and embrace a full-scale paradigm shift. https://lnkd.in/eHP7eNgu #DrugDevelopment #FortreaConsulting John Doyle, Dr.P.H.

For more than ten years, sponsors and researchers have discussed "patient-centric drug development," but clinical trials have stayed mostly the same. To genuinely improve patient experiences and health outcomes, we need to go beyond minor innovations and adopt a comprehensive paradigm shift. https://gag.gl/wE0cVC #DrugDevelopment #FortreaConsulting John Doyle, Dr.P.H.

I had the pleasure of talking with Danny McCarthy about the closed-loop drug delivery system we have been developing in the Langer and Traverso Labs, including how we envision it being implemented clinically. https://lnkd.in/dDiek7Wc