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| Ockham-India, a Global Contract Research (CRO) and Functional Service Provider (FSP) organization headquarters at Cary, North Carolina (near the university-biotech-pharmaceutical sciences nexus known internationally as Research Triangle Park). Satellite offices located in the region of the United States, in India and the U.K. underpin Ockham’s global customers and operations. |
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| Ockham endow with high-quality, universal clinical research and strategic development services to pharmaceutical and biotechnology companies, supporting them in the achievement of their strategic planning, technology transfer, licensing, pre-clinical development, and manufacturing goals. |
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| Ockham also provides fully integrated clinical trials support in the areas of Clinical Operations, Data Management and Biostatistics, as well as Regulatory dossier compilations. In addition, it offers functional and specialty resourcing services to pharmaceutical, biotech and medical device companies that require Clinical Operations, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), or Good Manufacturing Practice (GMP) , Statistical Programming and Biostatistics. |
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Clinical Project Management |
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Investigator site selection |
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Investigator grant negotiation and payment |
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Oversight of Clinical Research Associates (CRA) |
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Review and Approval of Site Visit Reports |
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CRA Training and Co-monitoring |
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Data Management |
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CRF/eCRF 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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Clinical Monitoring |
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Feasibility Survey |
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Site qualification visits |
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Site initiation visits |
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Interim site visits |
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Query management |
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Site close-out visits |
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Overall site management |
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EC submissions |
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Biostatistics |
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Support for Phase I-IV clinical trials |
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Statistical analysis support for studies
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Table / Listing production and QC |
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Expert consultation for statistical issues |
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Study design and consultation |
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Analysis plan development |
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Interim analysis/DSMB |
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