Self-Serve tier

Sponsor and vendor 21 CFR Part 11 compliance package for clinical-trial computerized systems (EDC, eCOA, IRT, eTMF, eConsent) covering validation, audit trail, signatures, ALCOA+.

Sponsor expedited IND safety reporting (7-day fatal/life-threatening, 15-day serious) under 21 CFR 312.32 and parallel 21 CFR 812.150 IDE UADE reporting.

Sponsor and PI compliance package for Form FDA 1572 commitments under 21 CFR 312.50-312.70 covering investigator selection, supervision, records, and disqualification risk.

Sponsor IND assembly + 30-day FDA review + clinical-hold / partial-clinical-hold response procedure under 21 CFR 312.20-312.42.

Sponsor / IRB consent-form audit against the eight basic + nine additional elements of 21 CFR 50.25 with 2018 Common Rule short-form parity check.

Sponsor compliance package for collecting Form FDA 3454 and 3455 covered investigator financial-interest disclosures across IND, NDA, BLA, 510(k), and PMA submissions.

IRB administrator compliance package for 21 CFR 56 registration, membership composition, written procedures, and FDA-inspectable records.

Sponsor IDE significant-risk vs non-significant-risk determination, IRB initial-review obligations, and exempt-investigation analysis under 21 CFR 812.

Sponsor compliance package for ClinicalTrials.gov registration and results reporting under FDAAA Section 801 / 42 USC 282(j) and the 2016 Final Rule (42 CFR Part 11).

Sponsor decentralized-clinical-trial (DCT) implementation package per FDA Final Guidance "Conducting Clinical Trials with Decentralized Elements" (September 2024).

BIMO 483 + Warning Letter response package: 15-business-day written response, root-cause analysis, CAPA plan, and re-inspection-ready binder.

Sponsor and CRO transition package from ICH E6(R2) to E6(R3) finalized January 2025: principles-based GCP, quality-by-design, risk-based monitoring, computerized systems.