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Blog posts
Six steps to help you choose the right clinical trial partner
“This year, we’ve decided to stick to paper. We know what we’re getting and we’ve always done it this way.”
That was the unwavering response from a clinical operations lead at a pioneering biotech when asked why they still relied on paper diaries for patient-reported outcomes.
Despite the growing complexity of global trials, the promise of real-time data, and the surge of digital capabilities available today, some organizations have held tight to a method of clinical trial conduct that’s increasingly as outclassed as it is outdated.
It’s well known that individuals and organizations believe that change can be daunting, stressful, and difficult, especially when the old way is familiar and entrenched. However, much like anything else, having a partner who can help guide you through the process is massively important. But, how do you find the right partner for your trials?
Before locking in a vendor, organizations must engage in a deliberate process to assess their needs, align stakeholders, and set the foundation for long-term success. This blog explores the critical steps sponsors should take before selecting a digital partner, using insights and frameworks drawn from Medable’s therapeutic area standards and industry best practices.
Interview: Biomarker/Endpoint guidance and why they advance science
Colin Miller is Co-Founder and CEO at The Bracken Group, a life science consultancy providing high-level expert support in imaging, regulatory, due-diligence, and more. A scientist by education, Colin has written more than 70 peer-reviewed scientific and medical publications, published 3 books, and holds 3 patents.
How to write clear and compelling patient recruitment material to drive enrollment and boost diversity
Clinical trials are essential for the development of new medical treatments and devices. However, enrolling patients in clinical trials is one of the most challenging aspects of conducting these studies. This is especially true when it comes to recruiting a diverse and representative patient population.
Improving diversity in clinical trials: An industry leader talks progress and surprises
We sat down with Rosamund Round, VP, Patient Innovation Center and Decentralized Trials at Parexel, about the challenge of improving diversity in clinical trials and what Parexel is doing to meet it.
Designing patient-friendly ePRO instruments
This blog explores why patient-centric ePRO instrument design is critical to driving study success, provides tips on how to make instruments more patient-centric, and offers resources for additional ePRO design guidance.
Clinician Reported Outcomes (CROs): A universal approach
Get the basics on ClinROs, why they are important, the industry governance around them, and how their electronic versions can benefit clinical trials.
Podcast: How do you ensure clinical trial access for all?
Medable CEO Michelle Longmire joins Beyond the Molecule Podcast to discuss how the industry can expand clinical trial access to all populations.
Informed Consent Forms (ICFs) for Clinical Trials: Write with plain language please
Informed consent is a critical element of any clinical trial, as it starts the process that leads to a patient's participation in a trial. An informed consent form (ICF) is written by sponsors and delivered to patients to provide them with all the information they need about the study to make an informed decision around their participation. Traditionally done with paper-and-pen, an effective ICF is clear, concise, and straightforward, while covering all of the required elements defined by regulatory bodies, such as Good Clinical Practice (GCP) as defined in ICH E6(R2). Unfortunately, many ICFs are not well-written, use overly scientific language, and are overly complex, which can confuse and potentially alienate a potential participant. This blog examines ways to improve this important communication process using clear language and the latest technology.
Where does patient recruitment end and patient engagement begin?
It’s widely understood that patient recruitment is one of the most critical and yet most challenging aspects to a successful clinical trial. In fact, many trials fail to reach recruitment goals, with far-ranging implications for investigators, sponsors, study participants, and the population affected by the disease or condition under study.