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| Synapse Labs’ is a "full service" Contract Research Organization providing services at all stages of clinical drug development. |
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Bioavailability and Bioequivalence |
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Protocol Design |
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Subject Recruitment & Screening |
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Clinical Study and Project Management |
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Method Development and Validation |
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Bioanalysis |
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Data Management & Statistical Analysis |
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Report Writing & Submission |
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Clinical Research (Phase II – IV) |
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Regulatory Consulting |
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Investigator site selection/feasibility studies |
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Clinical Trial Operations (Site Initiation, Monitoring and Closeout) |
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Clinical Trial Supplies Management |
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Site Management |
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Clinical Data Management |
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Setting up Clinical Data Management process |
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Clinical Data Processing |
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Medical Coding |
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Quality Control |
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Biometrics & Report Writing |
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Preparation of statistical analysis plan |
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Randomization, sample size calculation, power calculation, blinding & unblinding of data |
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SAS programming: SAS datasets creation, data listing, tables and graphs, program documentation, program validation |
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Interim & final statistical analysis |
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Preparation of clinical study report as per ICH E3 guidelines |
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Handling traditional problem areas in clinical report preparation (protocol deviations, patient disposition, compliance issues and changes to statistical methods) |
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Developing a clinical study reports that is comprehensive and easy to review |
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