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Neeman Medical International: Quick and Simple

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DQI Bureau
New Update

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.

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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.

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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."

Neeman Medical International

Industry:


Pharmaceutical




Business Issue:
  • Integration of all data
    sources

  • Need for a Web-enabled
    solution

  • Adherence to compliance

  • Continuous validation

Solution:
SAS PheedIT

Benefits:

  • An integrated and robust
    data entry portal

  • A Web-based solution

  • User-friendly
    application tool

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.

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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).

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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."

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