Episode 36: Siow Bee Seu – Clinical Trials Across Asia Pacific
Resources:Â [email protected] Siow Bee Seu, Director of Clinical Operations for APAC at Indero, shares her insights in this episode, drawing on nearly 20 years of experience in clinical research across the APAC region. She brings expertise in project operations, regulatory strategy, and team management throughout diverse APAC markets. Â The discussion focuses on three key […]
Strengthening data integrity in trials with subjective endpoints
Clinical trials that rely on subjective or semi-subjective endpoints, such as clinician-reported outcomes or patient-reported symptoms, face distinct challenges when it comes to data integrity. This PharmaTimes Magazine article, written by Janet Overvelde, Indero’s Senior Director, Project Management, highlights some lessons learned in the dermatology field, which relies heavily on subjective outcomes, and outlines strategies […]
Episode 34: Isabel Dorion – Beyond the Checklist: Elevating Clinical Research Associate Oversight for Quality and Impact
Episode 34: Elevating Clinical Research Associate Oversight for Quality and Impact Resources:Â [email protected]: Use this email to let us know what you want to hear about. The Essential Guide to Choosing the Perfect Clinical Research Associate Isabel Dorion, Senior Director of Clinical Operations at Indero, joins as todayâs guest. With over 25 years of experience […]
Q&A: Strategies for Successful Global Clinical Trial Delivery
In this Q&A, Randa Wahid of Indero, and Lyn Mursalo, a freelance clinical research professional, share how sponsors and CROs can build collaborative partnerships, navigate global trial complexities, and apply practical strategies to deliver studies on time and with quality. Read More
Measuring Success: Navigating the Top 3 Clinical Outcome Assessments in Hidradenitis Suppurativa
In clinical research, particularly in the study of hidradenitis suppurativa (HS), the evaluation of treatment efficacy is of paramount importance. This article provides a comprehensive overview of the 3 most commonly used clinical outcome assessments (COAs) in HS trials: the HS Clinical Response (HiSCR), the HS Quality of Life (HiSQOL), and the Hurley Stages of […]
Measuring Success: Navigating the Top 3 Clinical Outcome Assessments in Alopecia Areata
Alopecia areata (AA) is a multifaceted condition that presents unique challenges for both clinicians and patients. The precise evaluation of treatment results is pivotal in ascertaining the process of various therapeutic strategies. This article explores 3 key clinical outcome assessments (COAs) used in AA: the Severity of Alopecia Tool (SALT), the AA Investigator Global Assessment […]
Episode 32: Sarah Ballard – Strategic Storytelling: The Role of PR in Biotech & Pharma Stakeholder Engagement
ï»ż Resources: [email protected]: Use this email to let us know what you want to hear about. Strategies for Global Clinical Trials: Timelines, Communication, and Resilience Kdm-communications.com In this episode, Sarah Ballard, Agency Director at kdm communications, shares insights from over 20 years of experience in marketing within the scientific, technical, and medical B2B sectors. Renowned […]
Building Trust and Long-Term Relationships in Clinical Trials: A Guide for Biotech and Pharmaceutical Sponsors
Trust and long-term relationships are essential for the success of clinical trials. Building and maintaining these relationships between sponsors, CROs, and sites ensures smooth trial execution and high-quality outcomes. This article explores strategies for building trust and fostering long-term relationships in clinical trials, with a focus on what biotech, and pharmaceutical sponsors need to know. […]
From Theory to Practice: Breaking Down Risk-Based Monitoring in Clinical Trials
The risk-based approach to monitoring emerged over a decade ago, guided by directives from the FDA. The onus of its implementation, however, was placed on sponsors and CROs. Observations reveal a spectrum of risk tolerance among sponsors, necessitating a flexible approach from CROs. Despite the diversity in risk-based decisions within the program, the unwavering objective […]
Leveraging Specialized Knowledge: The Benefits of Niche CROs
The selection of a contract research organization (CRO) is a monumental decision that can significantly impact the success of a study. While generalist CROs offer a broad range of services across multiple therapeutic areas, niche CROs specialize in specific fields, providing deep expertise and focused capabilities. This comprehensive analysis contextualizes the unique opportunities and advantages […]
