What does it mean to do the heavy lifting?

In clinical research, it means assisting with research and development of new drugs alongside pharmaceutical and biotechnology companies, helping them complete the routine work that turns the gears to make new medicines. 

Within pharma, contract research organizations (CROs) are indispensable partners in the advancement of clinical research who manage the complexities of clinical trials from protocol design to regulatory closeout, handling tasks like trial design, patient recruitment, data management, and regulatory submissions.

As a result, CROs have become indispensable partners in the advancement of clinical research who significantly contribute to our industry’s development of groundbreaking treatments, and human health.

However, the weights and the lifting methods have been changing. As Boston Consulting Group noted in their 2024 Nature article, clinical trials are becoming more complex. As a result, CROs face increasing pressure to deliver more with less.

Recognizing their importance in our mission and vision, Medable is excited to announce the launch of our comprehensive CRO partner program, designed to be a game-changing engine for growth and control in the clinical research industry.  

‍

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).

‍

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

‍

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.

As clinical trials rapidly modernize, government regulators work to evolve even as the same core principles apply. Still, decentralized clinical trials are – simply – clinical trials, as all research today is decentralized in some way, yet we lack global harmonization of regulations.

‍

Combining multiple market solutions at the site level can result in a negative experience due to different processes, login credentials, and redundant training. A unified DCT platform that works seamlessly with other core clinical systems to streamline workflows and simplify key trial processes.

‍