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Preparation
- Support of your pre-Clinical Program
We will review, clean, re-analyze and finalize reports of previously
completed pre-clinical and clinical studies.
Clinical Research Program Development
Our drug development specialists, academic/medical advisors and
senior biostatisticans will collaborate with your group and key
opinion leaders in the development of your clinical research program.
Regulatory Support
We will represent your company at (pre)-IND regulatory meetings
at FDA and Health Canada on study design and other statistical issues.
Planning Clinical Studies
We will develop research protocols, plan and initiate phase 1-2
clinical studies. To achieve the complex objectives of 'proof-of-concept'
and other early phase studies we have drug development specialists
and biostatisticans as well as international academic advisers to
chose an optimal study design.
Trial Management
We will
implement and manage your clinical studies in collaboration with
our sister company Context Clinical Research Inc. using Canadian
and/or US phase I clinical units and other research sites.
Data Management, Biostatistics
& Reporting
Our Clinical Data Management (including EDC), Biostatistics and
Medical groups will be available to complete your trials and produce
industry standard clinical study reports ready for regulatory submission,
manuscripts, presentation materials, etc. - compliant with regulatory
guidelines.
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