Deep Research
EClinCloud research grounded in public raw data, regulatory documents, and peer-reviewed evidence.
FDA COA Evidence Dossier in 2026: A Planning Crosswalk and Draft-Status ReviewMap COA evidence to the September 2025 discussion draft, compare stakeholder requests and keep draft proposals separate from effective submission requirements.
FDA Study-Data Standards in 2026: Selecting Compatible VersionsRecheck FDA catalog support windows, compatible model and guide versions, terminology releases and study-start dates before finalizing your study-data specification.
ICH E19 Safety Data Collection in 2026: CRF Scope and Analysis DenominatorsCompare ICH E19 collection classes, four implementation examples, regional exceptions and trial-specific laboratory schedules before configuring the CRF and analysis plan.
ICH M11 Protocol Template 2026: Which Fields a Study Builder Can Load Into EDC, RTSM and eTMF, and Which Stay TextRead the final ICH M11 technical specification row by row: 43 Value pick lists beside 244 Data and 284 Heading terms, one schedule component, and USDM v4.0 gaps.
UK SUSAR Reporting After the April 2026 Reforms: What a Protocol-Listed Exception Covers, and the Clocks and Records It Leaves in PlaceRead UK regulations 33, 34 and A32 from 28 April 2026: which SUSARs follow a protocol timetable, which keep the 7- and 15-day clocks, and which records remain.
Important Protocol Deviations in 2026: One Departure, Four Outputs Under ICH E6(R3), China GCP, EU/UK Serious-Breach Rules and FDA's DraftMap one protocol departure to the ICH E6(R3) importance grade, the China article 23 report, the EU/UK seven-day serious-breach decision and FDA's draft paths.
China's September 2026 Guideline on Computerized Systems and Electronic Data in Drug Trials: What Changed From the Draft and What a Study Build Must ConfigureCompare CDE Notice 2026 No. 44 with its November 2025 draft, ICH E6(R3) and China GCP, and mark each computerized-system control changed, reworded or unchanged.
Trial Records and TMF Review: FDA Citation Counts, Retention and Five Quality Checks (2026)Reconcile FDA record-related citation counts, retention rules and five practical quality checks for a reconstructable clinical trial record.
Decentralized Trial Elements: Evidence, Oversight and Country Review (2026)Map remote trial activities to evidence, oversight and country-specific requirements using FDA guidance, ICH E6(R3) Annex 2 and a documented implementation review.
Eligibility Criteria and Screening Burden: A Study-Build Evidence Review (2026)Translate eligibility criteria into source-linked decisions, test timing and laboratory rules, and interpret FDA observation counts with the correct denominator.
Dose Optimization After Project Optimus (2026): Early-Phase Oncology Designs and Data CapturePlan oncology dose-optimization data capture across exposure, tolerability, patient reports and intercurrent events, using bounded registry and regulatory evidence.
How Many Systems Does Your First Trial Need? A Registry-Derived eClinical Module Map for Small Sponsors (2026)A protocol-based guide to the records, workflows and eClinical capabilities needed for a first regulated clinical trial.