Run More Studies. With the Same Team.
Trialhelix removes the configuration backlog that keeps your CDMs from operating at full capacity. Less time on EDC builds — more time on data quality and sponsor relationships.
Where CRO Capacity Disappears
Phase I and II CROs lose billable hours to the same three operational bottlenecks. Trialhelix is designed to eliminate all three.
Manual EDC Configuration
Each new study requires CDMs to rebuild eCRF forms, visit schedules, edit checks, and derivation rules from scratch — even when 80% of the structure matches a prior study. This costs 3–5 weeks per study.
Query Cycle Overhead
Manual review processes generate redundant queries — the same data item queried multiple times, or queries on values that a properly configured edit check would catch at point of entry. Every extra query cycle adds 2–3 days to the loop.
SDTM Mapping at Data Lock
CDISC SDTM variable mapping is often started late — after the study is already collecting data — because CDMs are busy with EDC support. Late mapping creates a crunch at data lock that delays TLF delivery and FDA submission timelines.
How Trialhelix Fits Into Your CRO Operations
Trialhelix connects to your protocol documentation and DMP at study setup. It generates the EDC configuration — eCRF forms, visit schedule, edit check logic — as a structured output that your team reviews and approves before deployment. You are not delegating the decision; you are eliminating the manual assembly.
- Protocol ingestion from DMP template or direct upload
- eCRF form generation with CRF completion guidelines pre-populated
- Edit check rule library — 300+ validated checks aligned to CDISC recommendations
- SDTM domain mapping initiated at study build, not at data lock
- Audit trail from first configuration action to final database lock
Where CROs See the Fastest Returns
Phase I Oncology FIH Studies
First-in-human dose escalation studies with adaptive design elements. Trialhelix handles the IWRS randomization configuration and MedDRA-coded adverse event capture so CDMs focus on safety data review.
Study Build workflowPhase II Efficacy with PK/PD Endpoints
Studies with complex sampling schedules and derived endpoints need SDTM ADaM datasets that align with statistical analysis plans. Trialhelix auto-generates the PP and ADPP domain structures from your SAP.
Data Management moduleRepeat-Indication Rollouts
CROs running 3–5 similar studies per year in the same indication can use Trialhelix study templates to reduce per-study configuration time by up to 70% on the second and third builds.
EDC configurationLate-Phase Inspection Readiness
For CROs supporting NDA submissions, the Trialhelix audit trail and SDTM validation report provide inspection-ready documentation in standard formats — not custom exports that require interpretation.
Audit trail & securityWhat CRO Teams Say
"We used to spend the first three weeks of a new study in EDC build mode. With Trialhelix, we spend three days reviewing and approving a configuration our team didn't have to build from scratch. The time goes somewhere productive now."
L. Morris
Senior CDM, Phase I/II CRO, Boston
"The SDTM mapping runs as a parallel track from day one — not a scramble at the end. When we went to data lock, the Pinnacle 21 report was clean on the first run. That has never happened before on a new EDC system."
J. Chen
Data Manager, Rare Disease CRO, San Francisco
See Trialhelix on Your Study Type
A 30-minute technical call with our team covers your specific indication, study design, and EDC history. We walk through where automation applies — and where it does not.