/ lifecycle
The clinical trial lifecycle, end to end.
Thirty-eight stages, from study design through closeout. Click any stage to open its hub: what the stage does, where AI applies today, and the open questions worth watching.
Planning
6 stagesStudy Design
Frame the scientific question, endpoints, population, and statistical approach that anchor everything downstream.
02Protocol Design
Translate the study concept into an executable protocol: schedule of assessments, inclusion/exclusion, and operational detail.
03Trial Feasibility
Estimate whether the protocol can enroll on time and on budget across the intended geographies.
04Probability of Success
Score each program's probability of technical, regulatory, and launch success — the number that decides fund-or-kill and where portfolio investment goes next.
05Country Selection
Pick countries balancing patient availability, regulatory timelines, standard of care, and cost.
06Site Selection
Identify and qualify investigator sites likely to enroll, deliver quality data, and stay engaged.
Conduct
13 stagesStudy Startup
Everything between an approved protocol and a site's first enrolled patient: regulatory submissions, ethics review, site contracts, essential-document collection, and initiation visits, run in parallel across every site and country.
08EDC / Data Capture
Design and configure the electronic case report form and the edit checks that guard it.
09IRT
Interactive response technology: randomization, drug supply forecasting, and kit management.
10Drug Supply
The forecast made physical: manufacturing campaigns, blinded kit packaging and labeling, and shipment through depots and customs into site pharmacies, sized against enrollment projections that keep shifting.
11Labs
Coordinate central and local lab data flows, reference ranges, and sample logistics.
12ePRO / eCOA
Electronic patient-reported outcomes: compliance, device logistics, and questionnaire validity.
13Site / Patient / Staff Training
How everyone who touches a trial — investigators, coordinators, system users, patients, monitors — learns what they must do, on the protocol, its amendments, and every system it touches.
14Patient Recruitment
Find, screen, and enroll eligible patients through referral networks, EHR search, and outreach.
15Informed Consent
The founding transaction of enrollment: a person agrees, freely and informed, to participate — evidenced by a signed, ethics-approved form, but ethically constituted by a conversation the form only documents.
16Patient Retention
Keeping enrolled patients on protocol through every visit and procedure for the life of the study, as their circumstances change around a commitment made on day one.
17Clinical Operations
Run the trial day to day: monitoring visits, issue management, vendor oversight, and site support.
37Patient Experience
Follow one participant's path across the entire trial — first outreach or referral, informed consent, every visit and reminder, and years of follow-up after the study ends — as a single continuous experience rather than one function's isolated slice.
38Site Experience
Follow one investigator site's path across the entire trial — qualification, every sponsor system it must log into, every process a different function designed independently — from first contact through study closeout and the decision whether to work with the sponsor again.
Data
7 stagesBiospecimen & Central Labs
Physical custody of blood, tissue, plasma, and other specimens from site collection through processing, shipment, and years of frozen storage, governed throughout by what the patient consented to.
19Data Management
Own data quality end to end: standards, edit checks, query lifecycle, and clean-file readiness.
20RBQM
Risk-based quality management: identify critical-to-quality factors and monitor them centrally.
21Safety & Pharmacovigilance
The machinery that hears about harm and tells the regulator in time: case intake from every channel, triage, coding, causality assessment, and expedited reporting against statutory clocks.
22Site & Central Monitoring
The sponsor's oversight of a running trial: site visits, source data verification, protocol compliance review, and the central-monitoring layer that watches every site's data from one seat.
23Medical Review
Clinician-led review of safety and efficacy data during conduct, including AE narratives.
24Data Review
Cross-functional review of listings, patient profiles, and reconciliation status pre-lock.
Reporting
8 stagesSDTM
Map collected data into the CDISC SDTM standard for submission-ready tabulations.
26ADaM
Analysis datasets derived from SDTM to support statistical results and traceability.
27Real-World Data
Exploratory and secondary analysis using data collected outside the trial's own case report form — claims, EHR extracts, registries — to support feasibility, safety context, or post-approval evidence.
28Statistics & Programming
SAP execution: TFLs, primary and secondary analyses, and sensitivity work.
29Statistical Programming
Independently reproduce the primary analysis end to end — a second programmer, a second path to the same numbers — before either is trusted.
30Medical Writing
CSR, protocol amendments, and regulatory narratives written to a defensible standard.
31Submission & Regulatory
Package the evidence into eCTD-ready dossiers and manage agency interactions.
32Regulatory Reporting
The continuous stream of obligations a sponsor owes regulators and ethics committees while a trial runs and a product lives: DSURs, periodic benefit-risk reports, amendment notifications, and registry updates, each on its own clock.
Close
4 stagesInspection Readiness
Prepare sites, systems, and documents for regulatory inspection at any time.
34Database Lock
Freeze the clinical database once all data are clean, reconciled, and reviewed.
35Study Closeout
Close sites, archive documents, and complete final reporting obligations.
36Post-Approval & Publication
Life-cycle obligations once a therapy is approved: post-marketing requirement studies, long-term follow-up, primary results publication and public registry postings, and extended record retention beyond the active trial master file.