Data Management

Overview

TechnoSTAT staff will work closely with yours to provide your company with data acquisition and management procedures tailored to your needs.

At the core is our data management system Clinplus®, (www.clinplus.com), a comprehensive SAS® based platform compliant with 21 CFR Part 11, supporting WHODRUG and MedDRA coding. Our highly-trained data personnel – from data-entry professional upward – make every effort to minimize yours. We will meet your timelines and adjust our logistics to simplify yours. In close consultation with your staff, we shall develop a workable data management plan (DMP), comprehensive 'edit checks' document and a process that will rationalize the logistics and processes of query generation and resolution. Our QA/QC will ensure that the end product will meet both your expectation and the regulator's.

Paper CRFs

While a growing number of trials have moved toward e-clinical solutions, the traditional paper-based CRF is, for numerous studies, still the most cost-effective. Where appropriate, TechnoSTAT's data management will work with your researchers and staff to design the clearest, most efficient paper-based data collection tools. Our experienced data entry staff, and SOPs designed for GCP compliance, will ensure data integrity and conformity with regulatory requirements.

Electronic Data Capture (EDC)

TechnoSTAT offers comprehensive web-based e-clinical solutions using the Clinplus® platform. We will provide your company with electronic CRF design, development and implementation of an e-clinical solution tailored to your needs. Where best fits your company's needs, we can offer solutions that combine both web- and paper-based data acquisition.