Clinical Research

With the changing regulatory scenario clinical research will soon be more than just bioequivalence studies for most local companies. Pharmawisdom offers to conceptualize and design clinical trials as per regulatory requirements, prepare protocols, case record form, patient diaries, consent forms, oversee outsourcing of study management to the right vendor and offer guidance till final report generation. We have sufficient expertise to offer advice for all varieties of studies ranging from, preclinical, bioequivalence and all phases of clinical for both new and existing products

Our services:

• Gap analysis in clinical development
• Conceptualization of the study
• Preparation of the protocol
• Preparation of the CRF
• Preparation of consent forms, patient diaries
• Preparation of dossiers for regulatory and ethics committee submission
• Outsourcing of study management to the right vendor
• Supervision of the study execution, data management, pharmacovigilance
• Final report generation

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• Challenges, Clinical Trials in Asia
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