Blog posts
The future economics of CROs
The ground has shifted for FSO (functional service outsourcing) and Unitized FSP (functional service providers) contract research organizations (CROs).
For years, the playbook for managing these types of CRO economics was familiar. Sponsors negotiated rates while CROs managed headcount and utilization around those rates .
That playbook still holds true today in theory. However, the conditions underneath it have shifted enough that it no longer produces the results it used to. Funding is tighter, sponsors are smaller and more price-sensitive, timelines are compressing ahead of the patent cliff, and AI has moved from an experiment on the roadmap to a baseline expectation in every RFP.
None of that is unique to any one segment of the market, but these pressures land differently for FSO and unitized FSP providers than they do for full-service CROs. That’s because these businesses are built on rate cards for CRAs, monitors, and other functional resources. When sponsors squeeze rates or expect more output per unit, there's no broader program fee to absorb the hit, here the unit economics are the business.
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.