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
AI-powered clinical data management is transforming how pharmaceutical companies, contract research organizations (CROs), and healthcare institutions collect, process, validate, and analyze data across clinical trials. As the volume and complexity
In clinical trials, a SAS programmer observes undigested change facts in statistical tables, lists, and numbers used by regulators to evaluate a drug or device. SAS programming for scientific experiments
A sponsor submits a dataset package to the FDA, and three weeks later the review team sends back a technical rejection. Not because the drug data was wrong. Because the
A clinical biometry CRO provides specialized expertise in biostatistics, statistical programming, and data management to support scientific research. These services help sponsors effectively manage medical data, maintain compliance, and achieve reliable overview results.
An Independent Biometrics CRO offers dedicated biometrics expertise without conflicts of interest, allowing sponsors to receive objective data analysis, flexible support models, and customized solutions tailored to their research requirements.
End-to-end biometric services cover all stages of the clinical trial data lifecycle, including setup guidance, database enhancement, scientific fact management, statistical evaluation, programming, reporting, and look at regulatory submission training.
Global biometric services provide standardized processes, centralized statistical monitoring, consistent reporting in more than one country and peek at websites This allows organizations to handle complex global clinical trials extra efficiently.
Clinical research biometry generally includes biostatistics, statistical programming, scientific information management, registry verification, medical coding, statistical visualization, and regulatory reporting to support fully evidence-based scientific development.
Clinical trial biometrics ensures that data is viewed and appropriately collected, analyzed, and presented according to regulatory standards. High-fidelity biometric support can help fitness officials streamline submissions and improve record reliability.
Biometric outsourcing services allow pharmaceutical, biotech, and scientific device companies to access skilled specialists, advanced technology, and scalable assets while reducing operational costs and accelerating project timelines.
A full-service biometrics provider can offer biostatistics, information monitoring, statistical programming, high security, regulatory guidelines, and robust business information and compliance standards while prioritizing full capabilities.
For clinical trials, biometrics help ensure accurate record collection, validation, and analysis throughout vision. Strong biometric processes reduce errors, enhance decision-making, and increase confidence in test results.
A Biometrics CRO India provider can amazingly offer access to professional biometric experts, fee-efficient mode of transportation, international regulatory expertise, and scalable assistance for scientific experiments conducted in various medical fields.