Study Protocol Design
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Restorative Yoga
Restorative yoga focuses on holding passive poses for extended periods, promoting relaxation and reducing stress by engaging the parasympathetic nervous system.
Duration: 45 minutes
Concept Protocol
Study Protocol
Concept Protocol service focuses on capturing the initial study design ideas. Our service strives to facilitate discussions among project teams on the core elements of a study and encourage consensus before developing a detailed protocol. As part of this service, a concise document will outline the key objectives and potential operational challenges of the study.
Concept Protocol service involves the initial drafting of the study’s framework. This service includes:
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Identifying key research questions and objectives.
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Outlining the study’s rationale and potential impact.
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Establishing a preliminary study design for further development.
Study Protocol service offers a comprehensive plan for conducting research. It includes the study’s rationale, objectives, design, methodology, and statistical considerations. The protocol functions as a comprehensive manual for the research team, ensuring adherence to the outlined methods and facilitating the ongoing monitoring of the study progress.
Study Protocol service provides a detailed framework for conducting the study. This service includes:
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Describing the study's objectives, design, and methodology.
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Specifying participant selection criteria and procedures.
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Ensuring compliance with ethical and regulatory standards.
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Outlining statistical methods for primary and secondary outcomes.
Statistical Analysis Plan
Data Management Plan
Statistical Analysis Plan service outlines the specific statistical methods and analyses that will be employed in the study. The document encompasses information on the primary and secondary endpoints, methods of analysis, predefined comparisons, significance levels, and exploratory data analyses.
Statistical Analysis Plan offers a detailed description of the statistical framework employed in data analysis. This service includes:
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Outlining statistical methods for primary and secondary outcomes.
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Planning for interim analyses and handling of missing data.
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Preparing for the final analysis and reporting of study results.
Data Management Plan service establishes the protocols for data management across all stages of a project, from acquisition to archival. Plan includes data definitions, collection, access, and frequently asked questions, all aimed at addressing data management to prevent compliance and regulatory challenges.
Data Management Plan service ensures the integrity and security of study data. This service includes:
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Definition of study parameters
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Strategies for data collection, storage, and retrieval.
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Plans for data validation and quality assurance.
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Policies for data security, sharing and long-term preservation.
Safety Management Plan
CRF Design
Safety Management Plan service is committed to ensuring the safety of participants throughout the study. The devised plan encompasses the monitoring of adverse events, implementing safety reporting procedures, and the formulation of risk mitigation strategies.
Safety Management Plan service focuses on participant safety and risk management. This service includes:
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Monitoring adverse events and safety reporting.
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Implementing risk mitigation strategies.
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Ensuring ongoing safety assessments throughout the study.
Case Report Form (CRF) Design service involves designing a comprehensive data collection tool tailored to the specific needs of the clinical study. By design, the CRF captures all essential data points in a structured manner, guaranteeing precise and consistent data collection.
CRF Design service includes:
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Developing the CRF based on the study protocol.
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Creating user-friendly forms for data entry.
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Implementing validation checks to maintain data quality.