The 2025 Drug Information Association (DIA) Global Annual Meeting, held in Washington D.C., is beginning to wind down. As always, the conference has left a clear vision for the future of clinical trials. one defined by groundbreaking innovation, unprecedented global collaboration, and a profound commitment to patient well-being. This year's conference underscored key themes that are shaping the landscape of medical product development, with Artificial Intelligence (AI) and Real-World Data (RWD) taking center stage.

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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.  

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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).

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