Clinical Site Lifecycle on Life Sciences Cloud: Identify, Feasibility, Select, Activate, Monitor Objective: Give clinical operations one place to work a site from first identification to monitoring — Life Sciences Cloud — while CTMS, eTMF, EDC, and finance stay the systems of record for what they own. MuleSoft moves each stage's outcome to the system that needs it, so site selection does not live in spreadsheets and activation does not wait on re-keying. What's Getting Built LSC clinical (System API) — sites, investigators, feasibility, and activation records in Life Sciences Cloud · GET /sites, POST /feasibility, PATCH /sites/{id}/stage CTMS (System API) — study, site, and milestone records in Veeva CTMS or equivalent · POST /studies/{id}/sites, GET /milestones Site lifecycle (Process API) — moves a site through each stage and pushes outcomes to CTMS, eTMF, EDC, and payments · POST /sites/{id}/select, POST /sites/{id}/activate Enrollment monitor (Scheduler) — brings EDC enrollment and query status back to the site record · SCHEDULER daily, GET /sites/{id}/enrollment Value chain phase Phase 02 — Clinical Development. Phases I–III testing on human subjects to ensure safety and efficacy. Scope of this plan: The site lifecycle worked in Life Sciences Cloud and synchronized with CTMS, eTMF, EDC, and site payments. Data in this phase: Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and EHR. Receives from: Phase 01 — Research & Discovery. Hands off to: Phase 03 — Regulatory & Compliance. Prerequisites Anypoint Platform org with API Manager, Runtime Manager, and a non-production deployment target. Salesforce Life Sciences Cloud org with a connected app and an integration user scoped to the objects this plan writes. Secrets Manager or secure properties configured for every system credential. Named owner for each source system — integration stalls on access, not on code. Life Sciences Cloud clinical features configured for sites, investigators, and feasibility. CTMS, eTMF, and EDC API access — Veeva Vault Clinical or equivalent. Investigator identity from the HCP master, so a site investigator is the same person commercial knows. Architecture 1. Identify and feasibility Identify candidate sites and investigators from the HCP master, past performance, and CTMS history. Send feasibility questionnaires from LSC and score responses against the protocol's criteria. 2. Select and activate On selection, create the site in CTMS and open the expected document set in eTMF. Track activation documents and contract status, and mark the site active only when every gate is met. Send the activation milestone to site payments to start the payment schedule. 3. Monitor Bring EDC enrollment, screen failures, and open queries back to the site record daily. Flag sites behind enrollment plan while there is still time to add others. 4. Security and GxP compliance Validate the integration under GAMP 5 — requirements, design, IQ/OQ/PQ evidence, and a traceability matrix retained for inspection. Meet 21 CFR Part 11 and EU Annex 11 for electronic records and signatures on every GxP-relevant flow. Preserve ALCOA+ data integrity — attributable, legible, contemporaneous, original, and accurate — with audit trails no operator can edit. Encrypt regulated data in transit and at rest, and keep production payload visibility to validated support roles only. Treat a mapping change on a GxP flow as a controlled change under change management, never as a hotfix. Meet ICH E6 for site and investigator records, and file documents to the TMF Reference Model. For pre-built API specifications, implementation templates, and reference architecture, see the MuleSoft Accelerator for Life Sciences on Anypoint Exchange. Testing and validation Select a site in LSC and confirm it appears in CTMS with the eTMF document set opened. Activate a site with a missing document and confirm activation is blocked. Confirm daily enrollment counts on the site match EDC. Phased rollout Phase 1 — Connect Build the LSC and CTMS System APIs for one study. Link investigators to the HCP master. Phase 2 — Map and validate Run feasibility and selection for the pilot study in LSC. Add activation gates and the payments milestone. Phase 3 — Production Move new studies onto the LSC lifecycle. Add enrollment monitoring across the portfolio. Success metrics Days from site identification to activation. Sites activated with a complete eTMF document set. Studies selecting sites outside spreadsheets. Troubleshooting Investigator duplicates across studies — Likely cause: investigators created per study instead of linked to the HCP master. Fix: Match investigators against the master on creation. Deliverable: A site lifecycle worked in Life Sciences Cloud from identification to monitoring, with selection, activation, and enrollment kept in step with CTMS, eTMF, EDC, and site payments.