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At Diverse Lynx, we have adapted SAS drug development platform. It enables significant efficiency and productivity improvements within our organization, which translates into decreased development costs, faster time-to-market and improved earnings for our clients.
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Integration: Efficiently integrate and manage data from a wide range of sources – such as electronic data capture (EDC) systems, in-house clinical data management systems (CDMS), labs and Sponsors’ private systems. |
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Analysis and reporting: Ability to accurately assess and report on study data in a timely manner. Efficiently generate presentation-ready statistical summaries of clinical trials data and easily share results with researchers or reviewers on demand. |
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Discovery: Use our growing research information repository to rapidly investigate critical drug safety issues, pursue new marketing claims or explore potential product-line extensions. |
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Regulatory compliance: Enables document research content via integrated processes that provide versioning, audit trails and electronic signatures, as well as fully describing the relationships between all process inputs, transformations, analyses and results. |
Data Management & Analysis Team
At Diverse Lynx, the Data Management and Analysis team compromises:
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Data Entry teams at multiple levels |
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Data Validation Team: Validation specialists, Documentation managers, Medical coders |
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Team Leaders – SAS Programming |
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Experienced Biostatistician Team |
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Quality control Managers to oversee Data management teams |
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Data management team including Biostatisticians, SAS programmers and quality auditors, medical data validation and data entry operators |
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SAS suite ‘Pheed-IT’ is used as CDMS; SAS Analytics are used for analysis |
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21 CFR Part II, compliance system |
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RDE, E-CRF and paper CRF data entry can be done |
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High end security systems in place |
Medical Writing
At Diverse Lynx, our medical writers can:
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Write Clinical study protocols |
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Clinical study reports: Phase I, Phases II–IV |
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Bio-analytical reports, Non-clinical study reports |
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Investigator's brochures, ‘expert’ reports |
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New drug applications |
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FDA briefing documents, Regulatory reports and submissions |
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Integrated summaries of efficacy and safety |
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Manuscripts, Abstracts, Posters |
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Product labeling |
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