Data Management


Biostatistics


Medical Writing







Services Mix


Versagenics personnel have extensive experience in database design and development, data consolidation and statistical analysis. Beginning with the proposal process we are dedicated to providing exceptional solutions to the pharmaceutical, biotechnology and medical device community. One of the company founders is appointed as project team leader and provides a major point of contact throughout the project.

Committed to high quality data, Versagenics utilizes experienced project teams, and efficient, real world-tested processes to avoid inefficiencies and streamline the data management process. A dedicated team works with you from the project's outset - and throughout - to follow these processes and gain your sign-off at critical points of the project. They remain focused on exceeding your quality standards. Whatever your data needs might be, our project team adds experience, innovation and commitment to create, coordinate and deliver results that keep you moving forward.

Our secure Web portal allows you to review scanned images of case report forms (PDF format), summary study management reports, SAS datasets and study documentation. Our entire data management and biostatistical approach centers on adherence to the FDA's 21 CFR Part 11 guidelines. Our network environment has been qualified and our clinical data management system has been tested and validated.

Our database design and development strategy focuses on full disclosure of the database fields, their attributes and all data validity checks. Our summary study management reports provide you with critical details regarding the CRF page processing status by site and subject, query status, data clarification form status and age. Clean subject reports provide insight into the progress we are making in resolving outstanding issues for any study subject prior to database freeze. Reports demonstrating our consistency in medical coding and identification of outstanding and/or missing CRFs are also provided. You can 'look over our shoulder' and monitor our progress from anywhere. Data are usually provided as SAS datasets but can also be exported in other formats to meet your specific needs.