/ lifecycle

The clinical trial lifecycle, end to end.

Twenty-three 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.

01
Study Design
Frame the scientific question, endpoints, population, and statistical approach that anchor everything downstream.
02
Protocol Design
Translate the study concept into an executable protocol: schedule of assessments, inclusion/exclusion, and operational detail.
03
Trial Feasibility
Estimate whether the protocol can enroll on time and on budget across the intended geographies.
04
Country Selection
Pick countries balancing patient availability, regulatory timelines, standard of care, and cost.
05
Site Selection
Identify and qualify investigator sites likely to enroll, deliver quality data, and stay engaged.
06
Patient Recruitment
Find, screen, and enroll eligible patients through referral networks, EHR search, and outreach.
07
Clinical Operations
Run the trial day to day: monitoring visits, issue management, vendor oversight, and site support.
08
Data Management
Own data quality end to end: standards, edit checks, query lifecycle, and clean-file readiness.
09
EDC / Data Capture
Design and configure the electronic case report form and the edit checks that guard it.
10
Labs
Coordinate central and local lab data flows, reference ranges, and sample logistics.
11
IRT
Interactive response technology: randomization, drug supply forecasting, and kit management.
12
ePRO
Electronic patient-reported outcomes: compliance, device logistics, and questionnaire validity.
13
RBQM
Risk-based quality management: identify critical-to-quality factors and monitor them centrally.
14
Medical Review
Clinician-led review of safety and efficacy data during conduct, including AE narratives.
15
Data Review
Cross-functional review of listings, patient profiles, and reconciliation status pre-lock.
16
SDTM
Map collected data into the CDISC SDTM standard for submission-ready tabulations.
17
ADaM
Analysis datasets derived from SDTM to support statistical results and traceability.
18
Statistics & Programming
SAP execution: TFLs, primary and secondary analyses, and sensitivity work.
19
Medical Writing
CSR, protocol amendments, and regulatory narratives written to a defensible standard.
20
Submission & Regulatory
Package the evidence into eCTD-ready dossiers and manage agency interactions.
21
Inspection Readiness
Prepare sites, systems, and documents for regulatory inspection at any time.
22
Database Lock
Freeze the clinical database once all data are clean, reconciled, and reviewed.
23
Study Closeout
Close sites, archive documents, and complete final reporting obligations.

Planning

5 stages

Study Design

Frame the scientific question, endpoints, population, and statistical approach that anchor everything downstream.

Protocol Design

Translate the study concept into an executable protocol: schedule of assessments, inclusion/exclusion, and operational detail.

Trial Feasibility

Estimate whether the protocol can enroll on time and on budget across the intended geographies.

Country Selection

Pick countries balancing patient availability, regulatory timelines, standard of care, and cost.

Site Selection

Identify and qualify investigator sites likely to enroll, deliver quality data, and stay engaged.

Conduct

2 stages

Patient Recruitment

Find, screen, and enroll eligible patients through referral networks, EHR search, and outreach.

Clinical Operations

Run the trial day to day: monitoring visits, issue management, vendor oversight, and site support.

Data

8 stages

Data Management

Own data quality end to end: standards, edit checks, query lifecycle, and clean-file readiness.

EDC / Data Capture

Design and configure the electronic case report form and the edit checks that guard it.

Labs

Coordinate central and local lab data flows, reference ranges, and sample logistics.

IRT

Interactive response technology: randomization, drug supply forecasting, and kit management.

ePRO

Electronic patient-reported outcomes: compliance, device logistics, and questionnaire validity.

RBQM

Risk-based quality management: identify critical-to-quality factors and monitor them centrally.

Medical Review

Clinician-led review of safety and efficacy data during conduct, including AE narratives.

Data Review

Cross-functional review of listings, patient profiles, and reconciliation status pre-lock.

Reporting

5 stages

SDTM

Map collected data into the CDISC SDTM standard for submission-ready tabulations.

ADaM

Analysis datasets derived from SDTM to support statistical results and traceability.

Statistics & Programming

SAP execution: TFLs, primary and secondary analyses, and sensitivity work.

Medical Writing

CSR, protocol amendments, and regulatory narratives written to a defensible standard.

Submission & Regulatory

Package the evidence into eCTD-ready dossiers and manage agency interactions.

Close

3 stages

Inspection Readiness

Prepare sites, systems, and documents for regulatory inspection at any time.

Database Lock

Freeze the clinical database once all data are clean, reconciled, and reviewed.

Study Closeout

Close sites, archive documents, and complete final reporting obligations.