From The Industry Experts
-
New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies
5/16/2024
The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.
-
Maximizing Efficiency And Cost Savings In Life Sciences
5/16/2024
Discover how NetSuite's tailored ERP solutions, combined with Sikich's implementation expertise, streamline operations and navigate industry complexities to drive long-term success.
-
How Are PIs Paid? All The Options For Clinical Research Investigator Compensation
5/16/2024
Principal investigators' work is much needed and appreciated, but the issue of PI compensation poses challenges for both sites and sponsors. Stamford Health Executive Director of Research Suzanne J. Rose, PhD discusses.
-
Why Are So Many Non-Small Cell Lung Cancer Patients Receiving Immunotherapy Against National Guidelines?
5/15/2024
In a landscape flooded with PD-L1 inhibitor ads, our real-world evidence analysis sheds light on concerning deviations from NCCN guidelines, particularly affecting dual expressor NSCLC patients.
-
The Stakeholder Benefits Of EHR eSource In Clinical Trials
5/15/2024
Discover the transformative power of EHR eSource integration through the eyes of a clinical research coordinator and project director in an adaptive platform trial.
-
Eight Ways Medical Device Clinical Trials Differ From Drug Trials
5/15/2024
Delve into the nuanced disparities between medical device and drug clinical trials with eight critical differentiators shaping regulatory pathways and patient safety.
-
IRB Review Of Changes To Previously Approved Research
5/15/2024
Learn why understanding the intricacies of IRB review for study changes is essential for researchers and institutions, covering everything from minor amendments to significant modifications, ensuring compliance and participant safety.
-
CRO Leverages Integrated Central IBC Partnership To Initiate Sites
5/15/2024
Learn how a CRO was able to accelerate review times so COVID-19 vaccine trial sites could progress through site selection, IRB/IBC submission, approval, drug shipment, and complete site initiation visits in record time.
-
Discrepancies In Colorectal Cancer Care: A Deeper Dive Into Age And Risk Profile
5/15/2024
Advocacy efforts have propelled colorectal cancer into the spotlight, yet treatment disparities persist. Explore findings on diagnosis-to-treatment timelines and personalized care strategies for better outcomes.
-
How Health Information Technology Is Transforming Human Lives
5/15/2024
Here, the authors take a closer look at how these advancements are not just revolutionizing healthcare but also instilling hope for a brighter and healthier future.