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Science 37 passes third FDA inspection with no issues found

Wed, 08 Oct 2025 08:19:05 -0500

Science 37 completed its third FDA inspection with a No Action Indicated categorization and no Form 483 issued, according to a company statement. The inspection focused on the company's Direct-to-Patient Site operations in a Phase 3 primary biliary cholangitis study.

The FDA review examined Science 37's internal processes, technology platforms, data integrity, patient safety measures, protocol adherence, and Principal Investigator oversight. Science 37 enrolled 47% of the US study population in the registrational Phase 3 trial.

This marks the company's third consecutive successful FDA inspection in under two years. Previous inspections in March 2024 and April 2025 also resulted in NAI categorizations

Science 37 passes third FDA inspection with no issues found

Wed, 08 Oct 2025 08:19:05 -0500

This marks the company's third consecutive successful FDA inspection in under two years. Previous inspections in March 2024 and April 2025 also resulted in NAI categorizations

Science 37 passes third FDA inspection with no issues found

Wed, 08 Oct 2025 08:19:05 -0500

This marks the company's third consecutive successful FDA inspection in under two years. Previous inspections in March 2024 and April 2025 also resulted in NAI categorizations

Science 37 passes third FDA inspection with no issues found

Wed, 08 Oct 2025 08:19:05 -0500

This marks the company's third consecutive successful FDA inspection in under two years. Previous inspections in March 2024 and April 2025 also resulted in NAI categorizations

Science 37 passes third FDA inspection with no issues found

Wed, 08 Oct 2025 08:19:05 -0500

This marks the company's third consecutive successful FDA inspection in under two years. Previous inspections in March 2024 and April 2025 also resulted in NAI categorizations

Science 37 Completes Third FDA Inspection, Validating Quality of its Direct-to-Patient Site in Pivotal Phase 3 Rare Disease Trial

Wed, 08 Oct 2025 08:18:00 -0500

MORRISVILLE, N.C., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Science 37, a leader in enhancing patient access to clinical trials, today announced the successful completion of its third FDA inspection, further affirming the quality and compliance of its Direct-to-Patient Site for clinical research. The inspection concluded with a No Action Indicated (NAI) categorization recommendation by the inspector, with no objectionable conditions noted and no Form 483 issued.

The review centered on Science 37’s contribution in a registrational Phase 3 primary biliary cholangitis (PBC) study, in which the company played a significant role,

Science 37 Completes Third FDA Inspection, Validating Quality of its Direct-to-Patient Site in Pivotal Phase 3 Rare Disease Trial

Wed, 08 Oct 2025 08:18:00 -0500

The review centered on Science 37’s contribution in a registrational Phase 3 primary biliary cholangitis (PBC) study, in which the company played a significant role,

Science 37 Completes Third FDA Inspection, Validating Quality of its Direct-to-Patient Site in Pivotal Phase 3 Rare Disease Trial

Wed, 08 Oct 2025 08:18:00 -0500

The review centered on Science 37’s contribution in a registrational Phase 3 primary biliary cholangitis (PBC) study, in which the company played a significant role,

Science 37 Completes Third FDA Inspection, Validating Quality of its Direct-to-Patient Site in Pivotal Phase 3 Rare Disease Trial

Wed, 08 Oct 2025 08:18:00 -0500

The review centered on Science 37’s contribution in a registrational Phase 3 primary biliary cholangitis (PBC) study, in which the company played a significant role,

Science 37 Completes Third FDA Inspection, Validating Quality of its Direct-to-Patient Site in Pivotal Phase 3 Rare Disease Trial

Wed, 08 Oct 2025 08:18:00 -0500

The review centered on Science 37’s contribution in a registrational Phase 3 primary biliary cholangitis (PBC) study, in which the company played a significant role,

Science 37 Completes Third FDA Inspection, Validating Quality of its Direct-to-Patient Site in Pivotal Phase 3 Rare Disease Trial

Wed, 08 Oct 2025 08:18:00 -0500

The review centered on Science 37’s contribution in a registrational Phase 3 primary biliary cholangitis (PBC) study, in which the company played a significant role,

Science 37 Completes Third FDA Inspection, Validating Quality of its Direct-to-Patient Site in Pivotal Phase 3 Rare Disease Trial

Wed, 08 Oct 2025 08:18:00 -0500

The review centered on Science 37’s contribution in a registrational Phase 3 primary biliary cholangitis (PBC) study, in which the company played a significant role,

Science 37 Completes Third FDA Inspection, Validating Quality of its Direct-to-Patient Site in Pivotal Phase 3 Rare Disease Trial

Wed, 08 Oct 2025 08:18:00 -0500

The review centered on Science 37’s contribution in a registrational Phase 3 primary biliary cholangitis (PBC) study, in which the company played a significant role,

Science 37 Completes Third FDA Inspection, Validating Quality of its Direct-to-Patient Site in Pivotal Phase 3 Rare Disease Trial

Wed, 08 Oct 2025 08:18:00 -0500

The review centered on Science 37’s contribution in a registrational Phase 3 primary biliary cholangitis (PBC) study, in which the company played a significant role,

Science 37 Completes Third FDA Inspection, Validating Quality of its Direct-to-Patient Site in Pivotal Phase 3 Rare Disease Trial

Wed, 08 Oct 2025 08:18:00 -0500

The review centered on Science 37’s contribution in a registrational Phase 3 primary biliary cholangitis (PBC) study, in which the company played a significant role,

Science 37 Earns Frost & Sullivan’s 2024 Global Company of the Year Award for Decentralized Clinical Trials

Mon, 16 Sep 2024 08:00:00 -0500

MORRISVILLE, N.C., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Today, Science 37, a leader in enhancing patient access to clinical trials, announced that it has received Frost & Sullivan’s 2024 Global Company of the Year Award. Recognizing the market participant that exemplifies visionary innovation, market-leading performance, and unmatched customer care, the award solidifies Science 37’s growing influence in the clinical trial industry as it increasingly turns to decentralization to help overcome recruitment, enrollment, and retention challenges.