Bio-Statistics - SCNITS Pvt. Ltd. is a global technology solutions provider delivering end-to-end consulting, implementation, integration, and support services across industries. We help businesses optimize operations and achieve sustainable success through advanced and emerging technologies.

SCIT has experience working with large and small contract research organizations and large, mid-size, and small pharmaceutical companies. With extensive experience in all phases of drug development and numerous regulatory submissions across various indications, SCIT is positioned to provide strong statistical consulting and programming support utilizing sound scientific reasoning and the latest computing technology.

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Staff Augmentation

SCIT has access to a broad population of independent contractors who work under the direction of client management to provide temporary support for time-sensitive projects.

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CDISC Services

CDISC Conversion, Data Integration and Data Mapping services for SDTM, SDTM and ADAM dataset generating, ISS/ISE studies standardization.

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Data Safety Monitoring Support

Our statisticians and programmers have fulfilled various roles in support of Data Safety Monitoring Committees (DSMC). We can assume the responsibilities of the external unblended statistician who provides the unblinded data package for committee meetings, records meeting minutes and communicates with sponsor representatives.

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Statistical Consulting

SCIT has extensive experience in the drug development process. We can assist you in your program strategy, protocol development, CRF design, analysis plan development, and randomization schedule generation. We also provide statistical reviews of TFL packages and clinical study reports.

Statistical Programming Services

Clinical and Statistical Programming: SCIT is experienced in generating analysis datasets, programming tables, figures, listing packages, in-text tables for report writing, and case report tabulations for electronic submissions. We are also experienced in generating edit checks, data transfers and data listings in support of management departments.

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Power / Sample Size Estimation

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Protocol and SAP Preparation

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Specification Writing for SDTM, ADaM & TLF

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Analysis Dataset Generation

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Edit Check Programming for Data Management Team

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Creating Mock Shells for Tables and Listings

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Statistical Analysis

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Statistical Analysis Using Validated Tools Like SAS®

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SAS Programs Validation and QC of Reports

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Generating Tables, Listings and Graphs (Safety & Efficacy)

ADaM/SDTM/CDISC Programming: SCIT has expertise and experience programming CDISC-compliant SDTM and ADaM datasets.

Expert Bio-Statistics & Programming Solutions

From statistical consulting and CDISC services to advanced programming and regulatory support, SCITS delivers reliable, compliant and scientifically driven solutions for pharmaceutical and clinical research organizations.