It takes, on average, 12 years and millions of dollars for
an experimental drug to travel from lab to medicine chest
and only five in 5,000 compounds that enter pre-clinical
testing make it to human testing. You face increasing demands
to control R&D costs, shorten drug development times,
deliver more drugs to market and build shareholder value.
You must do all this and comply with stringent regulatory
requirements. Perhaps no other industry has more intensive
document management requirements. To succeed in this environment,
you need a records management partner with the knowledge
and methodologies to help you accelerate the drug development
process and ensure compliance.
For over 50 years we have been providing major pharmaceutical
companies with expert advice to ensure their records systems
are compliant, efficient and effective.
TAB records management professionals will benchmark your
document management practices against best in class systems.
We will apply our expertise to the development of a document
management solution that fits your organization, allowing
your scarce and highly skilled scientific staff to focus
on drug development.
"Over the past year, we’ve
worked with TAB to develop a classification scheme, retention
schedule, and implementation plan for our organization.
I think a lot of our success has come from the quality
of the training program. Usually the education process
is dry and it makes buy-in all the more difficult, but
TAB really excelled at making it fun and engaging for
everyone. Our thanks to TAB for being great business
partners. "
—Manager, Quality Systems, Janssen-Ortho Inc. |
Research and laboratory notes are the means by which your
research efforts and results are communicated, coordinated
and evaluated. New drug submissions are vital to the launching
of new products. Quality assurance records (production,
stability, batch sampling) provide the "corporate
memory" of quality assurance activities. By developing
and implementing a records management system for your organization
TAB will help you ensure the efficient and accurate management
of documents throughout the entire development process.
Classification and retention schedules are developed, active
documents are organized, controlled and retrieved — utilizing
supplies and software that identifies their location at
all times. Storage solutions protect the integrity and
security of all documentation, while maximizing available
workspace in development laboratories. Knowledge is organized
allowing information to be shared and you to make better
business decisions.
"The changes we implemented
have provided us with better information about our documentation.
Armed with better information, our users have been able
to identify and develop other process improvements."
—Facilities and Purchasing Manager, Pfizer |
Testing, phased clinical studies, trademark and patent applications
and intellectual property rights are key elements to the
development of pharmaceuticals. With millions of dollars
at stake, strict compliance with all regulatory, product
safety, privacy and corporate governance requirements is
essential. A clearly defined records management program
will outline your responsibilities in creating, maintaining,
and retaining critical records, It will also provide the
policies and procedures to your staff to ensure that you
are meeting your legal obligations.
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