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- Clinical Operations:
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MakroCare has qualified professionals and experienced staff at global level who can manage phase II - IV clinical research studies for the biopharmaceutical industries from study design and feasibility to patient recruitment, clinical monitoring, database design and document management, statistical analysis and reporting, worldwide submission documents, protocol development, and pharmacovigilance in accordance with the regulations set forth by the FDA, ICH and DCGI Guidelines. Depending on the study-specific requirements, we create a monitoring crew that consists of clinical research scientists, clinical research associates, clinical monitors, medical monitors and pharmacists.
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Our services include:
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Preparation of study
protocols -
Design and printing of case
report forms (CRF)
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Preparation of Clinical
Trial Applications (CTA)
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Selection and recruitment of
qualified investigators from our extensive pool of investigators
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Training of monitors and
site personnel
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Organization of
investigators' meetings
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Guidance for study sites,
on-site monitoring and in-house quality review
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Detailed progress reports
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Accounting for all fees and
payments
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Data processing in
accordance with current standards
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Biometric evaluation and
reporting of study results
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Quality control through
in-house and on-site audits