Protocol to First Site Access in 4–6 Business Days
The study build workflow covers everything from protocol receipt to CDM approval and first site access — without the 3–5 week manual EDC configuration cycle.
How Study Build Works in Trialhelix
Protocol Upload and Parsing
The CDM lead uploads the protocol synopsis and DMP to Trialhelix. The system parses the study design — indication, Phase, visit schedule, endpoints, and safety assessments — and generates a draft study structure for CDM review. Time: Day 1, 1–2 hours.
eCRF Form Generation and Review
Trialhelix generates eCRF form structures for each visit and domain: demographics, vital signs, AE, concomitant medications, lab results, and endpoint-specific forms. The CDM reviews each form in a structured approval workflow — adding or modifying fields as needed. Time: Days 1–2, 4–6 hours of CDM review time.
Edit Check Configuration
The edit check library matches checks to the approved eCRF structure — range validations, cross-form consistency checks, required-field logic, and derived-field calculations. The CDM reviews the applied rules and configures any study-specific custom checks. Time: Day 3, 2–3 hours.
IWRS Randomization Setup
Randomization algorithm (block, stratified, or minimization), stratification factors, treatment arm labels, and drug supply configuration are set up in parallel with EDC build — not as a sequential step. Time: Day 3–4, concurrent with edit checks.
UAT and Go-Live Approval
A UAT environment is provisioned for the CDM lead, sponsor observer, and designated investigators to review the eCRF interface and test data entry before go-live. CDM approval creates an auditable sign-off record. First site access is provisioned immediately after approval. Time: Days 4–6, including sponsor review window.
Inputs Required for Study Build
Protocol Synopsis or Full Protocol
The protocol document (PDF or structured format). Trialhelix extracts the visit schedule, study objectives, and endpoints. No structured template required — the system parses standard protocol document formats.
Data Management Plan
The DMP or equivalent study specification. Trialhelix uses the DMP to understand CDM team structure, expected data collection schedule, query management process, and SDTM delivery expectations.
CDM Lead Availability
The CDM lead needs to be available for approximately 6–10 hours over the 4–6 day build window — for form review, edit check sign-off, and UAT. This is substantively less than the 3–5 week traditional EDC build commitment.
Start with Your Next Study Build
A 30-minute call covers the study build workflow on your specific study type — oncology FIH, rare disease Phase II, or repeat-indication rollout. Bring your protocol synopsis.