Biometrics
10 Ways a Biometrics CRO Improves Clinical Trial Quality and Compliance
A Phase III dataset with a clean audit trail and a shaky one can look identical on the surface. The difference only shows up when an FDA reviewer or an
Your submission deserves more than a checklist.
Strategic IND, NDA, or BLA planning, along with DCGI dossiers, designed to proactively address regulatory expectations.
Code that survives FDA review, not just sponsor review.
Dual-programmed SDTM/ADaM datasets and TLFs mapped right from Day 1, not reverse-engineered at the end.
Clean data at lock not after three rounds of cleaning.
EDC build, DVS authoring, MedDRA, & SAE reconciliation structured upfront so database lock is a milestone, not a crisis.
We Provide Reliable & High-Quality Biometrics CRO Services for Clinical Trials
Weltrix is a Contract Research Organization (CRO) dedicated to advancing clinical research and accelerating the development of life-saving therapies for patients worldwide.
- ICH-GCP Aligned
- CDISC SDTM / ADaM Compliant
- FDA & DCGI Regulatory Support
- R Programming
- 50+ Collective Years of Expertise
Why Biotech Sponsors Choose Weltrix
- Senior Access, Always – Every study is managed and executed by senior biostatisticians and statistical programmers. Your trial never gets handed to a junior team after kick-off. Direct email access to the expert doing the work.
- Technically Deep – We operate natively in CDISC SDTM/ADaM, SAS® Base/Macro, R (tidyverse, Shiny), and Python. Our programmers don’t just write TLFs, they architect compliant data pipelines that survive FDA review.
- Agile & Transparent – Adaptive study management. Rolling deliverables. Data pipelines that survive regulatory review. You see progress in real time not just in quarterly status calls.
Our Services
End-to-End Biometrics & Clinical Data Services
Biostatistics
SAP, Protocol-embedded Statistical Analysis Plans (SAPs), sample size & power calculations, estimand framework (ICH E9(R1)), interim analysis design, DSMB report, & CSR statistical sections.
Data Management
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.
Clinical Programming
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).
Statistical Programming
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
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
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.
Working Process
Structured Execution. Measurable Outputs.
1
Scope & Feasibility
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.
2
Statistical Analysis Plan
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.
3
Programming & Analysis
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.
4
Regulatory Deliverables
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.
Weltrix vs. Traditional Large CROs
| 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 |
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Collective Years of Expertise
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Core Service Disciplines
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Senior-Led Delivery
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Regulatory Frameworks
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