Strategic IND, NDA, or BLA planning, along with DCGI dossiers, designed to proactively address regulatory expectations.
Dual-programmed SDTM/ADaM datasets and TLFs mapped right from Day 1, not reverse-engineered at the end.
EDC build, DVS authoring, MedDRA, & 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.
SAP, Protocol-embedded Statistical Analysis Plans (SAPs), sample size & power calculations, estimand framework (ICH E9(R1)), interim analysis design, DSMB report, & CSR statistical sections.
EDC build and validation (Medidata Rave, REDCap, Oracle InForm), CRF design, Data Validation Specifications (DVS), SAE reconciliation, medical coding (MedDRA / WHO Drug), and database lock support.
End-to-end clinical trial support from Phase I first-in-human studies through Phase IV post-marketing trials spanning eCRF setup, site activation, protocol deviation tracking & randomization (IXRS/IVRS).
SAS® and R-based programming of Tables, Listings & Figures (TLFs). CDISC SDTM/ADaM dataset creation, define.xml generation, and submission-ready deliverables for NDA/BLA/ANDA packages.
Regulatory Affairs includes mainly eCTD submission planning and eCTD preparation, IND, NDA, or BLA module authoring, DCGI dossier support, FDA Pre-IND/Pre-NDA meeting preparation, and ICH-GCP audit readiness.
Medical Writing includes Clinical Study Reports (CSRs per ICH E3), Statistical Analysis Plans, Investigator's Brochures (IBs), protocols, informed consent forms (ICFs), briefing documents, and product labels.
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
Three weeks before a planned database lock, someone finally runs the comparison listing. The clinical database shows 47 serious adverse events. The safety database shows 44. Two of the gaps
Companies outsource regulatory affairs for a handful of practical reasons. It turns a fixed cost into a variable one. It gives them expertise that would take years to build in-house.
Your submission can fail before a reviewer opens a single document. When a package reaches FDA’s Electronic Submissions Gateway, an automated validation pass runs against it. If a required dataset
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