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Clinical Program Planning and Scientifically Credible Trial Designs
We will develop research protocols, plan and initiate all phases
of clinical trials. We have drug development specialists, academic/medical
advisors and senior biostatisticans to identify the most effective
path for your clinical development program and design your individual
clinical studies.
Effective
Trial Management
We will manage your clinical studies in collaboration with our sister
company, Context Clinical Research Inc. As required, we will work
with your
in-house staff or other CROs.
Data Management, Biostatistics
& Reporting
Our Clinical Data Management (including EDC), Biostatistics and
Medical Communication groups offer cost-effective and on-time solutions
for your trials: industry standard clinical study reports for regulatory
submission, manuscripts, presentation materials, etc. Our services
fully comply with regulatory agency guidelines (ICH, TPD, FDA).
SAE Management, ISS Databases
and Reports
Develop and maintain your product's safety database integrated across
all clinical studies for the preparation of various regulatory safety
updates, ISS report and supporting your product development decisions.
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