Neeman Medical International: Quick and Simple

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."