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Clinical Protocol and SAP Development Services
We provide full support in the creation and improvement of HIS protocols and SAP frameworks. We empower healthcare organizations to create precision, compliance, and efficiency within their digital operations.
Systems Quality protocols and SAPs are critical for establishing accuracy, compliance, and efficiency in Health Information Systems (HIS). However, protocol and SAP creation is often difficult and requires a technical and clinical perspective to create the data workflow that is compliant with regulatory and operational standards.
We offer design, development, and validation services that align your organization’s needs for HIS protocols and SAP. Our subject matter experts offer support throughout the entire process from ideation and data mapping to go live, testing, and documentation, ensuring your HIS backbone is fully scalable and compliant.
Our subject matter experts offer support throughout the entire process from ideation and data mapping to go live, testing, and documentation, ensuring your HIS backbone is fully scalable and compliant.
By deploying best practices in data management and system design we can assist health organizations with workflow improvements, interoperability, and accuracy in reporting. We empower your team to leverage data to make decisions, improve patient care and deliver quality care at a high standard of digital delivery.
Evidence-Informed Framework
At Statswork, we have developed our Protocol and Statistical Analysis Plan (SAP) using evidence-informed principles. We assist organizations in developing specific, data-informed research protocols that guarantee methodological rigor and clarity of scientific direction from the outset.
Rigor & Quality Assurance Procedures
Our professional support provides a rigorous statistical and methodological framework to ensure that every protocol and SAP we contribute to is reliable, non-biased, and international standard research aligned. This serves to ensure that study outcomes are defensible, credible, and publication ready.
Transparency & Scientific Transparency
Statswork develops according to internationally recognized and adopted guidelines for protocol and SAP development. Every step in our organization is transparent, and reproducible, with evidence-informed rigor and scientific approachability - supporting clarity, resource effectiveness, and measured research ROI
Creation of custom protocol
Our company designs custom protocols for your research that establish reasonable study aims, methodologies, and analytic plans. Protocols are designed to achieve scientific rigor while conforming to ethical standards. This way, you can feel that your study is designed for success from the start.
Development of a statistical analysis plan (SAP)
We write a complete statistical analysis plan (SAP) that includes the statistical methods you wish to use, plans for dealing with data, and describing the analytic plans that your study will use for analysis. We want to assure that all analysis is robust, reproducible, and in accordance with the aims of the study.
Review and revision of methodology
We will evaluate your study and its methodology thoroughly and propose improvements to strengthen its design and analysis. Our goal is to improve study validity and reliability and reduce bias as needed.
Regulatory and ethical compliance
Statswork will ensure your study protocol and SAP meet the regulatory and ethical standards of ICH-GCP, FDA, EMA, or other standards, for your compliance and potential regulatory approval.
Our Industries
At Statswork, we specialize in the development of Protocols and Statistical Analysis Plans (SAPs) for organizations in the healthcare, pharmaceutical, and research industries. Statswork assists organizations in executing methodologically sound studies with scientifically plausible, organization, and supported Protocols and SAPs, bolstering research integrity and improving regulatory and scientific compliance.
Creating Strong Research Frameworks
We produce comprehensive study protocols and statistical analysis plans (SAPs), that lay a clear path for your study. Each of our structured outlines gives a defined path, assuring that every single study objective, design, methodology is both scientifically rigorous and supports regulatory specifications.
Assuring Methodological Rigor and Compliance
With a lot of planning and adhering to best practices internationally, we help you to maintain methodological rigor and compliance. With our knowledge and stringent process, we help assure that every step – from the hypothesis to the analysis plan is be documented in an open, objective, and defensible manner.
Confidently Moving from Planning to Execution
With a clear Protocol and SAP developed, executing the study should provide clarity, efficiency, and ease. Statswork makes it easy for researchers and organizations to gain efficiencies in workflow, as well as reduce the chance of succumbing to errors, all resulting in defensible credible results for publication, helping to improve decisions and outcomes in research.
1. Customized Protocol Framework Development
We develop custom research protocol frameworks according to the intended purpose of your research, ensuring every component from the rationale for the study through the design and methodology is scientifically sound, clear and adheres to/fulfills international research standards, such as ICH-GCP and CONSORT.
2. Comprehensive SAP Development
Our scientists will develop a comprehensive study-specific statistical analyses plan (SAP), including the statistical methods, data handling and analysis plan. We also guarantee the provided statistical analyses plan is methodologically sound, reproducible and that the study is designed to yield valid and interpretable results.
3. Regulatory and Ethical Imperatives
We understand that regulatory imperatives, ethics and publication standards are all part of the protocol and SAP, so we help integrate these meta standards into the protocol and SAP, including minimizing risks of bias or deviations, and other obligations to institutional and global research-edited standards.
4. Review, Validation, and Optimization
Statswork reviews and deep checks the study design and SAP for clarity, feasibility and rigour is performed, while optimizing the process for two overall objectives: rigour and enhancing throughput to boost the credibility of your research.
5. Strategic Insights and Implementation
We will also provide strategic insights and consultation throughout the (timely) implementation of the protocol and SAP. Enabling you to strengthen your capacity to undertake the study in a manner congruent with confident, accurate, transparent or reproducible outcomes.
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