Regulatory Assessment and
Validation
Customer: The client is a blue-chip
large biopharmaceutical company with 1000’s of employees.
It has multiple products that are already on the market
and 10’s of therapeutic diagnostic products in development
or clinical trials.
Problem: The client was dealing with
a large body of clinical data from multiple drugs across
many countries. This data was not available in an
integrated manner and the challenge was to develop and
an approach that would provide an integrated view into
all the existing internal and external clinical data in
real time.
Solution: Tribiosys is currently managing
the development of a critical, high visibility Knowledge
Management (KM) application within the regulatory affairs
group. The KM application will be rolled out to hundreds
of users globally. The 21 CFR Part 11 compliant application
will consolidate and secure regulatory information to
eliminate repetitive, complicated searches for regulatory
information. This application will support the product
development lifecycle by providing targeted information
to all personnel and establish compliance with electronic
records management.
Tribiosys is managing the entire project from RFP management,
vendor selection and finalization, design, development,
testing, SOP development, validation, user training development
and delivery, data loading and conversion and corporate
rollout of the application to various US based and international
divisions of the company. The KM application is being
developed using state of the art Microsoft technology.
Tribiosys is also coordinating the corporate IT initiatives
towards the adoption of these new technologies. The architecture
and technical infrastructure of this application will
provide a sound foundation for future KM initiatives at
the pharmaceutical company.
Tribiosys is managing a project team of 30 individuals
and an extended project team of over 50 individuals and
a multi-million dollar budget.
Additional
case studies -Regulatory Assessment and Validation
