Managing Clinical Investigator Site Inspections: Key Strategies for Success
By Nuno Pires (Director, GxP Strategy) and Ernesto Vera Sanchez, MD, MPH, PhD (VP, Department Head, GxP Strategy) In our previous blog, “Inspection-Readiness: What You Need to Know to Prepare for a GCP Inspection”, we explored the broader concept of inspection-readiness, emphasizing the importance of adhering to Good Clinical Practice (GCP) guidelines to ensure overall compliance […]
Achieving Operational Excellence in Clinical Research Organizations: A Catalyst for Biotech Success
By Diane Francisco, Senior Director, Operational Excellence, Global Clinical Operations In a 2023 quantitative survey from Industry Standard Research (ISR) of 239 Phase II/III pharma and biotech outsourcers “Operational excellence” ranked number two out of 24 categories, when asked “What were the top reasons for choosing to work with a CRO” (ISR Phase II/III CRO […]
Enabling Patient-Centric Drug Development: Opportunity for Clinical Pharmacology to Leverage Innovation and Advance Diversity and Inclusion in Clinical Trials
Excerpted from keynote address at the American Conference on Pharmacometrics, November 2023 By Lisa Benincosa, PhD (Senior Vice President, Clinical Pharmacology Strategy) In today’s ever-evolving landscape of healthcare, the concept of patient centricity has taken center stage. Patient-centric drug development means putting the patient at the center of all we do. We strive to develop […]
Sample Size Re-Estimation: Risk Mitigation at the Planning Stage
Discover an informative webinar to explore the intricacies of sample size re-estimation in clinical trials and how assumptions around treatment effects, endpoint variability, and practical considerations impact trial success. The planned sample size for a clinical trial involves several assumptions around expected treatment effects and endpoint variability as well as practical considerations. At the trial design stage, […]
Navigating the Challenges of Clinical Trial Design
Industry Featured Article Effective clinical trial design and execution play crucial roles in the successful introduction of a drug to the market. However, the journey toward a meticulously planned clinical trial is fraught with challenges, capable of ensnaring even the most seasoned sponsors. Crafting an efficient recruitment strategy, formulating the trial’s design, and maintaining clear […]
Pediatric Clinical Trials: Tackling Clinical and Therapeutic Development Challenges Head-On
There remains a crucial need to include children in clinical development as historically they have been underrepresented in clinical trials. This is due to the complexities of including children, their vulnerabilities and the lack of motivation for drug developers to pursue marketing authorization for pediatric populations. These challenges faced in developing pediatric medicine are not […]
A Journey of Collaboration and Future Transformations in Biotech Space
In an exclusive interview with Life Sciences Review, Marcus Delatte, PhD, Vice President, Regulatory Strategy, Allucent, shared his valuable insights on the challenges and trends of the industry. He also talked about how technology is shaping the future of the biotech marketplace. Click below to read the full article. Read here
Patient-Centric Approach To Accelerating Clinical Trials
In an interview with Life Sciences Review, Anita Nelsen, senior vice president, clinical trial operations, Allucent, provides a general outlook on the current clinical trial landscape and highlights the value of a patient-centric approach. Click below to read the full article. Read here
Lessons Learned as Early Adapters of the EU’s Clinical Trials Regulation
By Marita Kruskopf Osterberg, PhD and Bernarde Bau, BSc, MSc The European Union’s Clinical Trials Regulation (CTR) has harmonised the process for authorisation and supervision of clinical trials in EU and the European Economic Area (EEA). Originally deployed on 31st of January 2022, the new process makes it possible to submit one online application to gain […]
How to Overcome Challenges in Combination Immunotherapy Clinical Trials
Immunotherapy has quickly become a major focus in the world of cancer research and treatment. In recent years, there has been a surge in the number of biotech companies conducting clinical trials for combination immunotherapies. What are Combination Immunotherapies? The combination immunotherapy approach involves the use of two or more different types of immunotherapies in […]