Track Clinical Trials from Protocol to FDA Submission

A Phase II clinical trial involves 200–500 discrete tasks across 12–24 months: protocol development, IRB approvals (one per site), patient enrollment, data collection, adverse event reporting, interim analyses, and regulatory submissions. These tasks have strict sequential dependencies — you cannot enroll patients before IRB approval, and you cannot submit results before data lock. Traditional tools like Microsoft Project create Gantt charts that become unreadable past 100 tasks. Spreadsheet trackers lose the dependency relationships entirely.

Organize by trial phase with zones: • Protocol Development — protocol writing, statistical analysis plan, case report form design, IRB submission packages • Site Activation — site selection, site initiation visits, IRB approvals per site, equipment delivery • Enrollment & Treatment — patient screening, randomization, treatment administration, follow-up visits • Data Management — data entry, query resolution, database lock, unblinding • Regulatory — IND amendments, annual reports, safety reports, NDA/BLA preparation Use milestone cards for hard gates: First Patient In, Last Patient Out, Database Lock, Submission Date.

Each clinical site gets its own color. Site-specific cards (IRB approval, site initiation, enrollment targets) are color-coded so you can scan the canvas and see which sites are behind. A CRO managing 8 sites for a Phase III oncology trial used this approach and identified that 2 sites were 6 weeks behind on IRB approval — early enough to add backup sites and keep the enrollment timeline intact.

FDA submissions have rigid dependencies. Map them with connectors: • Protocol finalization → IRB submission → IRB approval → First Patient In • Last Patient Out → Data Lock → Statistical Analysis → Clinical Study Report → NDA Submission Run Critical Path Analysis to identify the longest chain. In most trials, the critical path runs through enrollment — the phase with the most uncertainty.

Create a dedicated Safety zone for serious adverse event (SAE) tracking. Each SAE gets a card with type, severity, and reporting deadline. FDA requires SAE reporting within 15 calendar days (7 days for fatal/life-threatening events). The AI flags any SAE cards approaching their reporting deadline without a "Submitted" status. This catch alone justified the tool for one mid-size biotech company that had previously missed a 15-day reporting window.