A clinical trial involves a sponsor, a CRO, five clinical sites, three labs, and a regulatory body. Each one has its own systems, its own validation processes, its own compliance requirements.
No single organization can reconcile all of that alone.
Precision medicine is already multi-institutional. Assays, trials, therapies, and evidence all cross organizational boundaries. A variant is discovered in one lab, validated by another, matched to a therapy by a third, and documented for a regulator by a fourth.
Take the MARIPOSA trial, a Phase III study of amivantamab plus lazertinib in EGFR-mutated non-small cell lung cancer. The trial involves dozens of clinical sites across multiple countries, each with its own EMR, its own lab information system, its own regulatory requirements. Patient eligibility depends on genomic profiling results from different sequencing platforms. Response assessment depends on imaging from different radiology systems. Safety reporting depends on adverse event data captured in different EDC platforms. No single organization controls this data. But the regulatory submission requires a single, coherent evidence package that proves all of it composes.