Phase I through Phase III clinical operations

First-in-human Phase I trial — sponsor oversight of CRO across three investigator sites

A clinical-stage biotech sponsors a Phase I FIH trial using a CRO for site management and data collection. goPLIMS governs the sponsor’s oversight — CRO deliverable actions tracked in ActionR, site activation milestones in TrackR, protocol documents and IB in EDocM, and all CRO queries managed via RFI-M — giving the CMO real-time trial status without daily CRO calls.

Phase II multi-centre trial — managing CRO performance and site enrolment across 12 sites

A specialty pharma sponsor manages a 12-site Phase II efficacy study using goPLIMS for CRO oversight — each site’s activation and enrolment milestones visible on one TrackR dashboard, all CRO queries governed as RFIs, and protocol deviation CAPAs tracked in ActionR — giving the VP Clinical the programme status in one view, not twelve email threads.

Phase III pivotal trial — managing parallel protocol amendments across FDA, EMA, and Health Canada

A Phase III global pivotal trial requires a protocol amendment following a DSMB recommendation. goPLIMS governs the amendment across all three regulatory jurisdictions simultaneously — amendment document in EDocM with version control, regulatory submissions tracked as actions per market, IRB approvals recorded, and site implementation actions assigned and tracked — all on one platform.

Capturing Phase II trial lessons to inform Phase III protocol design

After Phase II results, the clinical team uses goPLIMS DecisionM to capture lessons learned — patient selection criteria performance, endpoint sensitivity findings, site performance patterns — and feeds these directly into Phase III protocol decisions. The Phase III team has a searchable record of Phase II learnings before first protocol draft, avoiding repeated mistakes and documenting the rationale for Phase III design choices in the regulatory submission package.

Protocol approvals, amendment sign-offs, and CSR approvals are signed with timestamped, intent-captured electronic signatures meeting FDA 21 CFR Part 11 and ICH E6(R2) requirements for electronic records in clinical trials.

Every document creation, version update, and approval action in the Trial Master File is captured in an immutable, timestamped audit trail — so inspectors can trace the complete history of every TMF record from first draft through archive.

Sponsor teams, CRO project managers, and investigator sites each have precisely scoped access — CROs see their study workstream, sites see their own site records. No over-sharing of confidential protocol or safety data across parties.

Clinical trial data — protocols, patient safety data, CRO correspondence — is never co-mingled with other sponsors or industries. Dedicated storage and infrastructure meeting the data security requirements applicable to clinical research.

Trial records retained for the regulatory-required archive period — 15 years post-marketing authorisation for clinical trial records — with automated backup, encryption, and access-logged retrieval meeting GCP and regulatory archive requirements.

The governed action register, RFI log, and real-time dashboard produce an audit-ready body of evidence demonstrating active sponsor oversight of outsourced CRO activities — meeting the ICH E6(R2) requirement that inspectors specifically review during GCP inspections.