
26/08/2025
Lifecycle of a Clinical Trial: From Concept to Closeout
Clinical trials are the backbone of drug development. Each study follows a structured lifecycle to ensure safety, efficacy, and compliance. Here’s a simplified overview:
1️⃣ Concept & Protocol Development
Designing the trial, defining objectives, endpoints, and methodology.
2️⃣ Regulatory & Ethics Approval
Submitting protocols to regulatory authorities & ethics committees for clearance.
3️⃣ Site Selection & Initiation
Identifying qualified investigators, training staff, and activating study sites.
4️⃣ Patient Recruitment & Enrollment
Enrolling eligible participants while ensuring informed consent.
5️⃣ Trial Conduct & Monitoring
Collecting data, monitoring patient safety, and ensuring protocol adherence.
6️⃣ Data Management & Analysis
Cleaning, validating, and statistically analysing study data.
7️⃣ Regulatory Submission
Compiling results for submission to health authorities (FDA, EMA, etc.).
8️⃣ Closeout & Reporting
Final site visits, archiving essential documents, and publishing results.
Each phase is vital to bring safe and effective treatments to patients.
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