Strategic IND/NDA/BLA planning, DCGI dossiers, and eCTD publishing built to anticipate the agency's next question.
Pinnacle 21-validated, dual-programmed SDTM/ADaM datasets and TLFs mapped right from Day 1, not reverse-engineered at the end.
EDC build, DVS authoring, MedDRA coding, and SAE reconciliation structured upfront so database lock is a milestone, not a crisis.
Weltrix is a Contract Research Organization (CRO) dedicated to advancing clinical research and accelerating the development of life-saving therapies for patients worldwide.
Share your protocol, indication, and phase. We conduct a rapid technical feasibility review assessing EDC platform, statistical complexity, regulatory pathway, and timeline within 5 business days.
Before a single line of SAS code is written, we co-develop the SAP, define CDISC domain structure, and map all analysis datasets. This prevents downstream rework and ensures FDA/PMDA alignment.
Independent Quality Control (IQC) on all TLFs and datasets. Dual-programming methodology on critical outputs. CDISC conformance checks via Pinnacle 21 Enterprise before any submission package delivery.
Submission-ready eCTD modules, define.xml, Reviewer's Guides (RGs), and annotated CRFs formatted to FDA/EMA/CDSCO standards. We stay on until the agency is satisfied.
| Key Factor | Weltrix | Typical Large CRO |
|---|---|---|
| Team Structure | Senior experts own delivery end-to-end | Rotating junior teams post-kickoff |
| CDISC Programming | SAS + R, Pinnacle 21 validated from Day 1 | Often reverse-engineered at study end |
| Study Start-Up | <2 weeks contract to EDC go-live | 6–10 week onboarding cycles |
| SAP Development | ICH E9(R1) estimand-native, co-authored | Template-driven, limited customization |
| Communication | Direct; async + sync; version-tracked | PM intermediaries; delayed escalations |
| Pricing Model | Transparent fixed-scope or FTE/FSP | Opaque change-order-heavy contracts |
| Technology | Adapts to sponsor's EDC, CTMS, data tools | Mandates proprietary CRO platforms |
| Regulatory Alignment | FDA, EMA, DCGI, ICH-GCP, GDPR | Varies by region and team familiarity |
Collective Years of Expertise
Core Service Disciplines
Senior-Led Delivery
Regulatory Frameworks
Data Management Services in CRO: Elevating Clinical Research for Weltrix In today’s clinical research environment, the role of data management services within a Contract Research Organization (CRO) like Weltrix is
Statistical Programming and Analysis Services in CRO In today’s highly regulated and data-driven clinical research landscape, Statistical Programming and Analysis Services offered by Contract Research Organizations (CROs) are vital for
Clinical Programming Services in CROs. The Transformative Impact of Clinical Programming Services in CROs: The Weltrix Perspective In today’s rapidly evolving landscape of clinical research, Clinical Programming services have risen