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Nov 13, 2024 | 
clinicalleader.com | Dan Schell |Heidi Chen |Meghan Hosely
Right-sized for biotech successIt’s not the size of your company. It’s the size of your passion and your dedication to improving patients’ lives that IQVIA Biotech is uniquely built to serve. There is nothing bigger to us than your success. We’ve got you. Using Direct-To-Patient Deliveries For Supply Chain ManagementUCB Vice President – Head of Global Clinical Science and Operations Tero Laulajainen gets us up to speed on direct-to-patient (DTP) trials and how UCB is leveraging it today.
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Sep 14, 2024 | 
clinicalleader.com | Dan Schell |Aurea M. Flores |BS Pharm |Meghan Hosely
AUGUST'S BEST FEATURED EDITORIALEasy Mistakes To Make During An FDA InspectionAs a former FDA investigator, Vincent Cafiso has heard — and seen — it all when it comes to what NOT to do during an FDA inspection. Here he gives some good advice on who you should have present in the room during an inspection and how you should interact with the investigator. What Clinical Trial Information Do VCs And Investors Actually Want?
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Aug 1, 2024 | 
clinicalleader.com | Meghan Hosely
PDA/FDA Joint Regulatory Conference 2024The PDA/FDA Joint Regulatory Conference 2024, the only FDA co-sponsored pharmaceutical CGMP conference, is taking place 9 to 11 September in Washington, D.C. Now in its 33rd year, the conference will offer a comprehensive agenda with substantive technical sessions and practical case studies that provide insight into the effective application of Current Good Manufacturing Practice (CGMP).
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Jan 19, 2024 | 
clinicalleader.com | Meghan Hosely
Article
| January 19, 2024
By Meghan Hosely, Marketing Content Manager
Undoubtedly, eSource holds the promise of enhancing the clinical research process by facilitating efficient and precise data collection. The elimination of manual data transcription not only results in substantial cost savings but also significantly reduces the time invested in a study. Despite these benefits, the adoption of eSource poses challenges for numerous research facilities.
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Dec 20, 2023 | 
clinicalleader.com | Jocelyn Reynolds |Heidi Chen |Meghan Hosely
How Can Electronic Data Capture Better Serve Decentralized Clinical Trials? Will EDC evolve to fix its existing problems, or will a different type of DCT platform (or single platform model) replace pick-and-pull, add-and-subtract modules of clinical trial technology?
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Nov 17, 2023 | 
clinicalleader.com | Meghan Hosely
Article
| November 17, 2023
By Meghan Hosely, Marketing Content Manager
In the last five years, the initiation of clinical trials has undergone significant transformations, marked by the rise of decentralized trials, enhanced technology utilization, and a growing demand for expeditious therapy market entry. These factors collectively contribute to the dynamic evolution of the clinical research landscape.
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Oct 18, 2023 | 
clinicalleader.com | Meghan Hosely
By Meghan Hosely, Marketing Content Manager
In the realm of clinical development, precision, compliance, and quality assurance reign supreme. In any intricate and heavily regulated industry, the occurrence of non-conformities and deviations is a foreseeable reality. An effective corrective and preventive action (CAPA) process is an indispensable instrument for proactively addressing these non-conformities.
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Sep 25, 2023 | 
clinicalleader.com | Meghan Hosely
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Article
| September 25, 2023
By Meghan Hosely, Marketing Content Manager
In the process of conceiving research studies and enlisting participants, research institutions are obligated to uphold stringent standards of compliance and ensure the utmost safety for those involved. To achieve this, the establishment of a comprehensive and compliant study becomes paramount.
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Sep 20, 2023 | 
clinicalleader.com | Meghan Hosely
Article
| September 20, 2023
By Meghan Hosely, Marketing Content Manager
The clinical research landscape continues to grow in complexity and competitiveness, with organizations grappling with a multitude of trials and tight deadlines. The clinical trial process is not only costly and time-intensive but also statistically prone to failure, with less than 12% of drugs and therapies advancing from clinical testing to approval.
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Jul 19, 2023 | 
clinicalleader.com | Meghan Hosely
Article
| July 19, 2023
By Meghan Hosely, Marketing Content Manager
Clinical trials are essential investigations that rely on human volunteers to explore and advance prevention, detection, and treatment methods for various medical conditions. The primary objective is discovering safer and more effective approaches to managing illnesses by evaluating new drugs or novel combinations of existing medications.
