5.1
65
Clinical Development Plan & Study Governance
Govern clinical development plans, studies, decisions, risks, and cross-functional actions.
View toolkitStage 5
Clinical development platform
End-to-end operational controls for designing, starting, running, closing and evidencing clinical trials.
What this stage covers
Study governance, protocols, startup, participant protection, TMF, monitoring, vendors, safety, data, statistics, and inspection readiness.
How it helps your team: Connect trial execution, evidence, and decisions across sponsor, CRO, and site responsibilities.
21 toolkits
Choose the operational area you need
5.2
65
Protocol Development & Amendment Management
Develop, review, approve, amend, and control clinical protocols.
View toolkit5.3
65
Study Startup & Site Activation
Manage startup, essential documents, investigator packages, site activation, and green-light approval.
View toolkit5.4
55
Site Feasibility & Investigator Selection
Assess site and investigator capability, suitability, and readiness.
View toolkit5.5
64
Informed Consent & Participant Protection
Control informed consent development, approval, versioning, monitoring, and deviations.
View toolkit5.6
65
Trial Master File & Essential Documents
Control TMF planning, completeness, QC, inspection readiness, and archiving.
View toolkit5.7
65
Risk-Based Monitoring & Monitoring Visit Management
Manage monitoring strategy, site visits, remote monitoring, issues, and central monitoring signals.
View toolkit5.8
65
Clinical Quality Management / QbD / RBQM
Apply quality by design, critical-to-quality controls, QTLs, risk controls, and breach assessment.
View toolkit5.9
65
CRO & Clinical Vendor Oversight
Oversee CRO and clinical vendors using KPIs, meetings, action tracking, and escalation.
View toolkit5.10
65
IMP Accountability at Site
Track site accountability, reconciliation, pharmacy activities, return/destruction, and temperature control.
View toolkit5.11
76
Clinical Safety / SAE / SUSAR Management
Control SAE capture, reporting, SUSAR assessment, escalation, reconciliation, and safety decisions.
View toolkit5.12
65
Protocol Deviation & Issue Management
Manage protocol deviations, issues, classification, escalation, actions, and trends.
View toolkit5.13
76
Clinical Data Management
Govern data management, EDC build, validation, data review, cleaning, source references, and database lock.
View toolkit5.14
65
CRF / eCRF Design & Data Review
Design CRFs/eCRFs, govern completion guidance, review data, and manage queries.
View toolkit5.15
65
Medical Coding & Reconciliation
Manage MedDRA/WHO Drug coding, coding review, safety-clinical reconciliation, and coding queries.
View toolkit5.16
65
Biostatistics & Statistical Analysis
Govern SAP, programming, randomisation, interim analysis, data review, and outputs.
View toolkit5.17
65
Data Standards / SDTM / ADaM Readiness
Prepare study data for standardised clinical submission datasets.
View toolkit5.18
65
DMC / Safety Review Committee
Govern independent or internal safety review, DMC decisions, recommendations, and data packages.
View toolkit5.19
65
Clinical Trial Closeout
Close sites, reconcile data, finalise TMF, resolve issues, lock database, and close deliverables.
View toolkit5.20
65
Clinical Study Report Management
Manage CSR development, QC, review, appendices, and finalisation.
View toolkit5.21
65
Clinical Trial Inspection Readiness
Prepare sponsor, CRO, sites, TMF, data, and staff for GCP inspection.
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