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.
Medable joins CancerX alliance to further the Cancer Moonshot
Along with some of the best companies in the world, Medable is proud to join CancerX as a founding member. This alliance is co-hosted by the Moffitt Cancer Center and the Digital Medicine Society (DiMe), alongside the Office for the National Coordinator for Health Information Technology (ONC) and Office of the Assistant Secretary for Health (OASH).
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Medable perspective: Three points on FDA eCOA guidance
At the beginning of April 2023, the FDA published a draft of the fourth in a series of Guidance Documents entitled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments (COA) Into Endpoints For Regulatory Decision-Making”. Once finalized these four documents will be combined and will replace the 2009 Guidance, “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims”. Part 3, which was released in draft in June 2022, provides advice around the development and validation of new COA (including the modification of existing COA).
Patient perspectives: Nine updated technology tips for deploying eConsent from Medable’s PCN
Since 2018, Medable has grown a network of patients, caregivers, and care partners whose job is to help improve the clinical trial experience for participants.
Known as the Patient Caregiver Network (PCN), they regularly update their best practices, including recently refreshing their technological best practices around deploying eConsent.
We’re sharing them below to help continually promote the participant's voice and to help foster more equitable, inclusive, and diverse clinical trials
Quality by design: How eCOA improves oversight and participant data quality
eCOA has the power to ease clinical research for all stakeholders. When developing and refining our eCOA offering, we consulted with our own Participant & Caregiver Network (PCN) to provide feedback on design. This allowed us to build our eCOA and the wider platform it fits within in a way that fosters better oversight, and better clinical trial data.
Podcast: Michelle Longmire and David Fajgenbaum of EveryCure join the PharmaExec podcast
Medable CEO Michelle Longmire and Dr. David Fajgenbaum, co-founder of EveryCure, join Pharmaceutical Executive podcast to talk about their partnership adn navigating the regulatory landscape.
Why the future looks bright for eCOA in clinical trials
See why the electronic clinical outcome (eCOA) market is poised to continue its rapid growth and why Medable customers have chosen eCOA as a future foundation for their next era of clinical conduct.
Bridging the gap: Ensuring sites are successful with Medable
For years, clinical research sites have been vocal about the technological challenges they face conducting trials. Obstacles such as multiple disparate systems per trial, an abundance of passwords, lack of interoperability, and other issues all showcase how technology can be as significant a hindrance as it is a boon. As a recent Forbes article suggests, if clinical research technology doesn’t empower sites, it risks slowing down the entire trial.
Connecting in new ways: Our partnership with Withings Health Solutions
In June, Medable announced a partnership with Withings Health Solutions with the goal of reducing the burden on sponsors and sites while empowering patients to participate in trials from home.
What does the new European Medicine Regulatory Network recommendation paper on decentralized elements in clinical trials tell us?
Learn what impacts the new European Medicine Regulatory Network recommendations paper means to your clinical trial operations.