Laying the Foundation: Mastering Site Selection for Effective Clinical Studies
Site selection is a foundational element in the success of a trial, akin to laying the groundwork for a stable and enduring structure. Understanding the nuances of site selection, including the importance of a dynamic site database and the evolution of site performance, is essential for contract research organizations (CROs) aiming to conduct effective and […]
Innovative Approaches to Study Design in Early Phase Dermatology Trials
Early phase clinical trials mark the transition from preclinical research to clinical application, characterized by unique challenges and opportunities. Key considerations include the difference between early and late phase trials, the importance of data quality, and the specialized techniques used in dermatology. Key Differences Between Early and Late Phase Trials The true distinction lies in […]
Streamlining Clinical Trials: The Power of System Integration
System integration in clinical trial management streamlines processes and reduces the burden on research sites. As clinical trials increasingly rely on multiple platforms to collect data, integrating these systems enhances efficiency and improves the quality and reliability of the data. Despite the costs, this investment is valuable for ensuring high-quality clinical trial outcomes. The Importance of System […]
When Placebo Plus Standard of Care Clouds the Signal: Unmasking the âPlacebo Problemâ in Lupus Clinical Trials
Dr. Juan Ovalles, Senior Director of Rheumatology at Indero, discusses how high placebo response rates driven by background therapy complicate lupus drug trials, and outlines evolving strategies in trial design, clinical practice, and pharmacist-led care to ensure investigational biologics are fairly evaluated and appropriately used in systemic lupus erythematosus. Read More
Patient-Centric Approaches to Managing Rheumatoid Arthritis Trials
Managing rheumatoid arthritis (RA) trials presents unique challenges and opportunities. RA patients often face significant pain and mobility issues, which can impact their participation in clinical studies. Effective management of these trials requires a comprehensive approach that addresses patient comfort, transportation, recruitment, retention, and site accessibility. Additionally, meticulous study management, including drug positioning, monitoring, and […]
Strategies for Global Clinical Trials: Timelines, Communication, and Resilience
Industry leaders Lyn Mursalo and Randa Wahid share their expertise on effective strategies for global clinical trials. Lyn Mursalo, Director of Clinical Operations at Escient Pharmaceuticals, excels in delivering complex trial protocols and strategic CRO partnerships. Randa Wahid, Senior Project Manager at Indero, formerly known as Innovaderm, brings over 12 years of experience and strategic […]
Ensuring Consistency: The Impact of Rater Training in Clinical Trials
Clinical rater training directly influences the accuracy of data collection and interpretation, which are critical for meeting regulatory standards. Effective clinical rater training ensures that clinical outcomes assessments (COAs) are reliable and meaningful. By involving key opinion leaders (KOL) in the training process, we can enhance the precision and consistency of these assessments, ultimately driving […]
Solving the Challenges of Patient Recruitment
PharmaTimes, the UKâs leading pharmaceutical magazine, John Clarke, Associate Director in Patient Recruitment at Indero, explores the transformative trends reshaping the pharmaceutical industry. This issue explores: The increasing role of self-care in national health, the critical importance of adherence in modern medicine, and the innovative dimensions emerging within the sector. With insightful articles on treatments, […]
Setting Your Sites on Successful Clinical Trials
In the article âSetting Your Sites on Successful Clinical Trials,â Anne Marie Gaulin, Executive VP of International Expansion at Indero, discusses: The pivotal role of investigative sites in clinical trials. Gaulin emphasizes that the selection of sites and nurturing long-standing partnerships with them are crucial for the success of clinical trials. The article explores […]
Putting Patients First in Clinical Trials
In the article âPutting Patients First in Clinical Trials,â published by Pharmaceutical Processing World, Julie Massicotte, Senior Director of Regulatory Affairs at Indero, emphasizes: The importance of prioritizing patient needs and experiences in clinical research. The piece discusses how involving patients in the design and implementation of trials can lead to more relevant and broadly […]
