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| Ockham-India endows with high quality, customer-focused services to biotechnology and pharmaceutical clients, including service in the areas like: |
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Project Management |
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Clinical Monitoring |
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Biostatistics |
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Data Management |
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Ockham-India services is differentiated by the level of experience and the expertise possessed by companies expert resource, a focus on customer service, flexible and logical project budgets with the dedication to add value to the customer interactions at every step of the process. |
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| Biostatistics |
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Optimal clinical trial study designs to meet regulatory and promotional needs |
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Statistical analysis support for studies conducted at all stages of drug research, development, manufacturing, and marketing |
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Assistance in presenting statistical methods before regulatory authorities |
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Expert consultation for statistical issues relating to drug discovery, formulation, laboratory development, animal studies, clinical development, evaluation/approval, manufacturing, and marketing research |
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Full support for Phase I-IV clinical trials Study design and consultation |
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Assistance with protocol development and verification of CRF design |
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Analysis plan development SAS programming for tables, figures and listings |
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Interim analysis/DSMB |
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Project Management |
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Investigator site selection |
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Investigator grant negotiation and payment |
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Study coordination |
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Budget and timeline management |
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Communication management |
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Detailed clinical review |
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Oversight of CRAs and project team |
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Clinical Monitoring |
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Site qualification |
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Regulatory documentation collection |
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Site initiation |
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Interim site visits |
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Query management |
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Site close-out |
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Overall site management |
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Data Management |
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CRF design |
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Database design and programming |
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Data coding |
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Validation |
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Query management |
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Data archiving |
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