We assist with the clinical development of compounds in your pipeline from proof of concept (Phase 2) to market enhancement (Phase 4) studies in several therapeutic areas. With years of pharmaceutical experience along with our global network of key opinion leaders, we ensure that your clinical development plans and pivotal studies are developed with a global submission target in mind, while allowing for the flexibility of local execution at the protocol level. We further assist our clients with identifying investigators for rapid patient recruitment of clinical trials in the US, Europe and India.
We provide the following services:
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Identification of investigational sites |
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Feasibility survey support for global studies |
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Regulatory strategies for global study conduct |
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Clinical Development Plan (CDP) support and maintenance |
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Protocol development |
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Case report form design |
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Informed consent document development and update |
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Consolidated IRB submissions for all sites and maintenance of approvals |
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Ongoing recruitment support and solutions for enhanced recruitment |
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