Minutes to proposal
Submit basic trial or study parameters for a fast, predictable fixed-fee proposal without tedious intake forms.
Every deliverable, from database configuration to submission
We bridge the gap between software platforms and operational reality, owning your data lifecycle from initial database configuration to final locked datasets and regulatory submissions — for human clinical trials and preclinical safety / toxicology studies alike.
Six core service areas
Each one is delivered by the same accountable team, under one contract — so nothing drifts between handoffs.
Clinical EDC Solutions
Part 11 and GCP-validated build, setup, configuration, and validation on TrialKit or legacy environments (Veeva, Medidata Rave, Viedoc, Oracle, Castor, Medrio).
Preclinical EDC & LIMS Data
End-to-end setup, validation, instrument data integration, electronic audit trail management, and compliance oversight for environments like Instem Provantis.
Study Conduct & Operations
Proactive query resolution, automated validation checks, continuous safety / SAE reconciliation, and standardized MedDRA / WHODrug medical coding.
Biometrics & Submissions
CDISC SDTM/ADaM dataset creation and SEND harmonization executed in parallel with study conduct; full SAS / R statistical programming.
Multi-Source Integration
Custom API pipelines connecting central labs, toxicology equipment, eCOA/ePRO, wearables, and specialty devices without operational bloat.
Database Rescue & Migration
Rapid platform-to-platform migrations, dataset re-architecture, and study rescue execution completed in 30 days or less.
Operational deliverables at a glance
| Core service area | Operational deliverables & capabilities |
|---|---|
| Clinical EDC solutions | Part 11 and GCP-validated build, setup, configuration, and validation on TrialKit or legacy environments (Veeva, Medidata Rave, Viedoc, Oracle, Castor, Medrio). |
| Preclinical EDC & LIMS data | End-to-end setup, validation, instrument data integration, electronic audit trail management, and compliance oversight for preclinical study management environments (including systems like Instem Provantis). |
| Study conduct & operations | Proactive query resolution, automated validation checks, continuous safety / SAE reconciliation, and standardized MedDRA / WHODrug medical coding. |
| Biometrics & submissions | CDISC SDTM/ADaM dataset creation (clinical) and SEND harmonization (preclinical) executed in parallel with study conduct; full SAS / R programming. |
| Multi-source integration | Custom API pipelines connecting central labs, toxicology equipment, eCOA/ePRO, wearables, and specialty devices without operational bloat. |
| Database rescue & migration | Rapid platform-to-platform migrations, dataset re-architecture, and study rescue execution completed in 30 days or less. |
What predictable delivery looks like
Tiered rate cards
Clear, predictable rates across data management, programming, and biostatistics — benchmarked well below traditional CRO market averages.
Rapid go-live
Clinical database or preclinical configuration go-live in 1 to 4 weeks depending on complexity; rescue rebuilds in 30 days or less.
1–4 wks
database / configuration go-live
≤ 30 days
study rescue & migration
Parallel
CDISC / SEND programming during conduct
SAS + R
biostatistics & statistical programming
Tell us about your study
Share your study phase, site / laboratory parameters, subject targets, and preferred platform environment — we will return a transparent, fixed-fee proposal.