Print

Comment

Email

Digg

Del.icio.us

Reddit

Twitter

Neeman Medical International (NMI), the International Site Management Organization, supports clinical trials enrolment needs of pharmaceutical, biotech, and CRO clients. Headquartered in Raleigh, North Carolina, NMI has its presence in the US, Costa Rica, and India. Each location provides comprehensive infrastructure needed to support clinical sites in each geographic area.

The Challenge
As part of its growth strategy in India, Neeman was getting into clinical data management services as an extension of site management services. This created the need for an integrated web enabled solution for clinical data management. Given their strict adherence to international standards Neeman needed to deploy a Web-enabled 21 CFR part 11 compliance solutions. Validation was also a key concern along with the need to Deploy-Train-Use on an urgent basis.

Why SAS?
Dr Ajoy Kumar, COO, Neeman Asia says, "We needed a single simple and efficient solution for the entire clinical research process that would meet all statutory data regulatory requirements. Besides, we needed to graduate to a completely electronic Web-based environment. SAS PheedIT solution met all the requirements perfectly."

SAS PheedIT, a Web-based solution, offered all the required components and experience for successful implementation. It provided a robust data entry portal integrated with the ability to handle data transformation, data imports and exports, analysis and reporting. It was a flexible management solution, which enabled any kind of sharing of Web-based information.

Given the urgency of the requirement, the SAS team completed the implementation including validation of the complete solution in just eight days.

Key Benefits
SAS PheedIT offered an easy-to-use tool/application for anyoneGPs, nurses, DMs, project managers, CRAs, and others with specific access rights. For specific studies PheedIT could also be linked to any Web-based information page. This turned out to be an effective way of informing investigators and getting close to opinion leaders. PheedIT allowed users to access partial study data and study performance reporting from checks and data management, which reduced the cost greatly. It allowed users to carry out retrospective studies, with import and export of data from the system. It allowed export of clinical study data into a more analysis-friendly structure (the analysis database).

This database is then used by the PheedIT report engine to generate standardized reports, analysis, graphs, etc, and can easily be used by internal/external statisticians who are given access to the system. With SAS PheedIT solution, Neeman International India has become the most reliable partner for clinical trials process and offers clinical data management services with the same adherence to worldwide, uniform standard of conduct, and SOPs that meet FDA and ICH requirements.

Dr Kumar says, "With SAS we found a partner who offers the best- in-class solution to overcome the ever growing challenges faced by life sciences organizations today. SAS PheedIT enables our network of more than 1,400 investigators conducting clinical research to work on a common integrated Web-based platform in a broad number of therapeutic areas like Oncology, Infectious diseases/vaccines, Pediatrics, Immune Dysfunction, CNS, Cardiology, Endocrinology, etc."

Page(s)   1