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Pharmaceutical
Clinical
Development
Phase II-IIIa | Phase
IIIb-IV | Phase
IIIB Programs | Phase
IV Programs
Phase
II - IIIa
Wability delivers the insight and expertise of clinicians,
regulators, scientists, and health economics experts with competencies
that cover every aspect of the drug development process. Our services
are available across multiple therapeutic specialties.
Wability
takes innovative approaches to provide high quality service within
budget by challenging assumptions about traditional clinical trial
design and management. Throughout the company, SOPs, communications
systems and high standards of quality, all ensure excellence in
these efforts.
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Phase
IIIb - IV
These type of studies are unique since they are designed to handle
commercialization issues just prior to, during and after core registration
studies have been conducted.
Wability
offers extensive experience in the design and execution of these
specialized trials. Our expert clinicians will work with your team
in order to create unique solutions to meet your specific needs.
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Phase
IIIB Programs
Many clinical trials often utilize Phase IIIB programs in their
protocols and their continuing clinical research development plans.
These programs transition patients from clinical development to
marketplace introduction.
Our clinicians
will work with you in order to optimize the design and conduct of
these programs including:
- Exploring
the use of special patient populations
- Strengthening
product safety profile
- Developing
product awareness
- Compiling
information on long-term usage
- Support of
marketing claims
The transition
from clinical development to marketplace introduction is key to
the success of any pharmaceutical, biotechnological or medical device
product. Wability offers high-level expertise in the design,
conduct, analysis and reporting of these programs.
These studies
may be highly structured like a standard Phase III design or a more
simplified trial design with a larger study database. The data must
be summarized at the time of regulatory submission and can be used
for publication when complete. In some cases, results have been
used to develop additional product claims within the product label.
Wability
can optimize your product's potential in order to help you gain
competitive advantage, while balancing critical clinical concerns.
We operate in accordance with the agreed upon schedule and budget.
Wability can help you develop quality programs---from inception
to completion.
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Phase
IV Programs
Phase IV programs are often utilized when clients want to:
- Conduct
"real-use" programs to expand effectiveness and safety databases
- Expand the
impact of existing marketing programs
- Integrate
Phase IV programs with product launch
- Complete
FDA mandated requirements
Proactive planning
of phase IV activities often determines the degree of market capture
for a drug. Research in phase IV also influences the activities
of the FDA with regard to post-approval commitments or safety and
efficacy concerns with the drug.
During Phase
IV, the following aspects may be the focus of the studies that are
often creative in design features, and may range from simplified
to complex clinical and epidemiological assessments, as well as
high-level and specialized statistical analyses:
- FDA mandate
- Safety confirmation,
(i.e., evaluation of rare or infrequent adverse events by conducting
large-scale trials)
- Expansion
of scientific understanding, leading to a competitive edge in
the marketplace, (i.e., comparative v. non-comparative studies,
impact on subpopulations, drug interactions etc.)
- Evaluation
of the drug for specialized markets such as pediatric use
- Expansion
of labeling and optimization of dose
Wability
can optimize your product's potential helping you gain a competitive
advantage while balancing critical clinical concerns. Each study
conducted by Wability will be delivered on schedule and at
budget, meeting the highest standards of quality.
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