ai powered Statistical Services for All industries
High Data Quality and Data Security based Reporting
ai powered Statistical Services for All industries
High Data Quality and Data Security based Reporting
Statistical Services Offered by VCLINICAL BIOSTATS as a CRO
A pharmaceutical company partnering with a CRO benefits from comprehensive, high‑quality biostatistics and data management services that ensure regulatory‑ready clinical submissions. These services include end‑to‑end biostatistical support, development of SDTM and ADaM datasets, and creation of Define.xml using industry‑standard FSP (Functional Specifications) models. The CRO manages raw data extraction, ETL processes, and meticulous aCRF review to ensure complete traceability from source data to analysis datasets. In addition, the CRO provides expert FDA submission (FDS) services, including compliance checks, dataset validation, and submission‑ready packages. Strong project management oversight ensures timelines, quality, and cross‑functional coordination, enabling pharmaceutical sponsors to confidently meet global regulatory requirements with accuracy, efficiency, and full compliance.
Team
Our team offers in-depth, end-to-end knowledge of both regulatory data standards and clinical SAS programming. We are experts at developing specifications, annotating CRFs, and mapping datasets to the Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) frameworks. Moreover, we can prepare SDTM and ADaM Reviewer's Guides, adhere to Clinical Data Interchange Standards Consortium (CDISC) restricted terminology, and use Pinnacle 21 for regulatory submissions in order to comply with FDA regulations.
In comparison to other comparable service providers, we are able to continuously map and deliver standard and quality datasets at a cost that is far more affordable because of our team of competent staff members.
In order to create efficient project management solutions and promptly inform our sponsors and clients, our crew is well-organized. This makes it possible for us to maintain a consistent level of performance, which ultimately results in meeting our predetermined objectives on schedule.
Study Activities and Experience
- Estimate and finalize budgeted hours based on study documents such as the Protocol, SAP, and available raw data.
- Perform effective resource allocation to ensure optimal utilization across study activities.
- Establish and maintain a structured study folder hierarchy in compliance with organizational and regulatory standards.
- Define organizational goals, develop detailed project timelines, and ensure timely completion of study deliverables.
- Plan and conduct weekly and monthly team meetings to track progress, address issues, and align on priorities.
- Maintain and update study trackers to monitor milestones, timelines, and overall project status.
Contact Us
📌USA
13809 Research Boulevard suite , Austin, TX 78750
📞 +1 737-259-8990
⌛MON-FRI
9:00am-5:00pm CST
📌 INDIA Flat No.301/5,3rd Floor, Alluri Trade Center, KPHB, HYD 📞+91 9398497194 ⌛MON-FRI 6:30pm-3:30am IST Mail:- Info@Vclinicalbiostats.com
