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 […]

Operationalizing Cell and Gene Therapy Trials

Originally published by BioPharmaDive Small and mid-sized biotech companies face unique challenges when bringing novel therapies to market. While many large pharmaceutical companies have the knowledge and in-house talent to clear regulatory hurdles and conduct efficient clinical trials, smaller companies often do not. That’s why small and mid-sized biotechs need to THINK BIG when working to […]

Why Multinational Clinical Trials are Key to Bringing Novel Therapies to Patients

Originally published by BioPharmaDive Small and mid-sized biotech companies face unique challenges when bringing novel therapies to market. While many large pharmaceutical companies have the knowledge and in-house talent to clear regulatory hurdles and conduct efficient clinical trials, smaller companies often do not. That’s why small and mid-sized biotechs need to THINK BIG when working to […]

Defining the Regulatory Roadmap for Product Success

Originally published by BioPharmaDive Small and mid-sized biotech companies face unique challenges when bringing novel therapies to market. While many large pharmaceutical companies have the knowledge and in-house talent to clear regulatory hurdles and conduct efficient clinical trials, smaller companies often do not. That’s why small and mid-sized biotechs need to THINK BIG when working […]