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We offer Clinical Research services that include clinical trail documentation, clinical data management, biostatistics in clinical trials, and more. Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These Clinical Research may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Our Clinical Research services are highly appreciated and valued by the clients. We believe that our rapid quality work and rational rates help us to better serve our customers.
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| | Clinical Trial Documentation High Quality Clinical Trial Documentation is an important and integral part of clinical research, specially essential for the successful launch of new drug/molecule formulation. Right from pre-clinical studies to post marketing periodic safety update reports documentation is involved in every step. Clinical Trial Documentation helps to facilitate the planning, execution and tracking of relevant clinical trial activities. Pharmaceutical companies may find it extremely beneficial to outsource the documentation work. Sankhya can provide the services to develop following key documents as a part of Clinical Trial. - Study protocol /Case Report Form (CRF)
- Standard Operating Procedures (SOP's)
- Statistical Analysis Plan (SAP)
- Report and Analysis Plan (RAP)
- Clinical Study Report (CSR)
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| | Clinical Data Management Service We provide Clinical Data Management services which are regulatory compliant & cost effective. Our quality Assurance process ensures zero error rates in the final database released for statistical analysis. Our extensive experience in this field enables us to provide a high quality CDM services. CDM services include - Designing Data Management Plan/Quality Assurance Plan/Data Validation Plan
- Data Entry (Independent double data entry)
- Serious Adverse Event reconciliation
Clinical Data Management Software used: Open Clinica Version 3.0 (Validated) Open Clinica is the world's first professionally supported 21 CFR compliant, open source clinical trials software for Electronic Data Capture (EDC) Clinical Data Management (CDM). | |
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| | Biostatistics In Clinical Trials Biostatistics In Clinical Trials We have a team of highly qualified and experienced statisticians ably supported by SAS programmers. We provide services at every stage of a Biostatistics In Clinical Trials - From finalizing study design to Clinical Study Report.
Our services in Biostatistics In Clinical Trials are - Estimation of Sample size
- Generation of Randomization schedule
- Developing and validating SAS codes
- Interim Statistical Analysis
- Final Statistical Analysis
- Data Integration & Meta analysis
- Exploratory Analysis
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| | Pharmacokinetic Analysis In BA And BE Pharmacokinetic Analysis In BA And BE Consulting services for developing key documents such as - Study protocol
- Standard Operating Procedures (SOP's)
- Sample Size Estimation (power analysis)
- Randomization Schedule Generation
- Analysis of Pharmacokinetic Analysis In BA And BE Parameters using Compartmental and Non Compartmental Modeling.
Statistical Analysis of the following Designs - Two way cross over design.
- Three way cross over design.
- Parallel design.
- Replicated cross over design.
- Steady state design.
Statistical Report Writing | |
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| | Training Modules We have designed Training Modules for statisticians as well as non statisticians.
Some of our training modules are:- - Biostatistics-Fundamentals for Statisticians/Non statisticians
- Biostatistics-Advanced
- Biostatistics in BA/BE studies
- Design of Experiments
Statistical Software like SPSS, SAS, R will be used for the above training modules. | |
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| | Biostatistics In BA And BE Our organization is engaged in offering services for Biostatistics in BA And BE. The services offered by us have activities related to understanding of biostatistic models with their statistical theory. It also includes statistical work in the field of environmental study, agricultural research and biology. Latest technology is used by our team members to render these services in an efficient manner. These services are offered at market leading rates for our customers. | |
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