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| Study
Design Protocol Development |
| Qtech
solutions offers full service support for study design and
protocol writing. Qtech solutions was founded by clinicians
who understand not only the clinical research arena, but also
the practical needs and priorities of practicing physicians.
This clinical expertise enables us to efficiently design studies
and develop protocols that serve as the roadmap for our client's
success. Without such insight, protocols risk being developed
in a way that is too academic for the practicing physicians.
Clients can rely on Qtech solutions to produce study designs
that yield the type of information regulatory agencies, as
well as practicing physicians, seek. |
| Qtech solutions have
an experienced set of professionals who can perform this design
and development process with a rapid turnaround time, while
still addressing all the possible study challenges and GCP/ICH
guidelines (http://www.ich.org).
Qtech solutions team, including our medical officers, biostatisticians
and medical writers, collaborate closely during this development
process, making sure that the final outcome is reflective
of clearly understood objectives. As a result of this collaborative
process product approvals and market acceptance can be optimized
from the start, avoiding common pitfalls that can otherwise
cost clients valuable time and money. |
| We have a clinical team
experienced with a range of study designs across medical specialties/therapeutic
areas. Our Clinical Affairs group begins research on the clinical
setting of the product: the therapeutic principles, FDA (http://www.fda.gov/)
guidance documents including product history, background literature,
competing product labeling and summary bases for approval,
as well as timelines and resources. Qtech solutions can assist
you with your study design for full protocol development and
comprehensive review of an existing protocol. Qtech solutions
team of clinical experts can help ensure that your study is
conducted efficiently, effectively, and in compliance with
ICH/GCP guidelines (http://www.ich.org) |
Study Design
- Phase I/II safety and dose finding
studies
- Phase II exploratory efficacy trials
- Randomized controlled phase III trials
- Phase IIIb and IV trials
- Pharmacokinetic and dynamic studies.
- Bio-equivalence and therapeutic equivalence
trials.
- Pharmacovigilance and pharmacoeconomic
trials
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Protocol Development
-
Statistical planning
(sample size estimation, randomization, and power
calculations)
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Complete protocol
development.
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Case Report Form
design.
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Literature review
and meta-analysis.
- CRF completion guidelines.
- Client representation or support
at regulatory meetings (INDs,NDAs).
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