Regulatory and Ethical Compliance for HIS Methodology
We guarantee that the HIS methodologies of yours comply with all applicable regulations and ethical requirements (e.g., ICH-GCP, FDA, EMA) thereby guaranteeing valid, defendable research and the lowest possible level of risk.
Ensuring Regulatory and Ethical Compliance in Health Information Systems (HIS)
By ensuring compliance with all applicable Federal and State Laws, as well as ethical standards, Health Information Systems (HIS) can be held to the highest level of integrity, security, and accountability. This includes the management of patient data, the privacy of patients’ information, and all reporting requirements in accordance with the various Key Regulatory and Ethical Guidelines.
We assist Healthcare Facilities to ensure their HIS is compliant with industry standards such as ICH-GCP (Good Clinical Practices), HIPAA, FDA and EMA, while reducing or minimizing the compliance risks
associated with these standards In addition, following industry standards reduces the risk associated with data mismanagement, patient privacy and regulatory compliance in an international arena.
At Statswork, we provide complete support with compliance assessments, gap analyses and ongoing monitoring of HIS to ensure that Health Information Systems are maintained in an ethically sound manner and aligned with continually changing regulatory requirements and standards throughout the entire lifecycle of the HIS.
Evidence-Informed Framework
Statswork ensures that your HIS methodologies comply with regulatory and ethical requirements by utilizing evidence-based principles to ensure that data handling and patient privacy are compliant with regulatory requirements from the beginning.
Rigorous and Quality Assurance System
Statswork provides you with comprehensive support in aligning your workflows to international standards such as ICH-GCP, HIPAA, FDA, and EMA while also ensuring compliance with these standards. This approach reduces your compliance risk, creates a legal defense for your system, and ultimately provides you with a better ROI on your HIS.
Transparency and Compliance Assurance
Statswork provides you with complete visibility and reproducibility following internationally recognized guidelines for transparency, while providing an opportunity to utilize resources in the most productive way possible. This approach reduces compliance risk while increasing the ROI on your HIS.
Compliance Standards Integrated into Your HIS
The integration of compliance standards into your HIS will enable you to collect, process, store, manage, report and communicate data in a manner that meets both the regulatory requirements of your local and international jurisdictions. This will enable your HIS to operate smoothly and without penalty, in all locations.
Regulatory and Ethical Compliance Assessment
The assessment of your Health Information System (HIS) for compliance with key regulatory and ethical guidelines, including but not limited to ICH-Good Clinical Practice (GCP), the Health Insurance Portability and Accountability Act (HIPAA), the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Creating Compliance Documentation and Reporting
The creation of comprehensive documentation supporting compliance with regulatory agencies, including the reporting of ethical considerations and how you secure and manage the privacy of patient information, will provide you with a transparent process in the event of an audit or regulatory review.
Continuously Monitoring Compliance
We will continue to monitor and update your HIS to maintain compliance with current and new regulations and ethical guidelines, thus reducing the potential for risk and maintaining the integrity of your system as new standards are introduced.
Our Industry:
Statswork is an industry leader for Regulatory and Ethical Compliance in Pharmaceutical, Healthcare, and Research Organizations. Compliance with ICH-GCP, FDA, EMA, and HIPAA, helps to ensure your Pharmaceutical, Healthcare and/or Research Organization remains compliant with the key legal, ethical and data privacy regulatory standards, while the integrity and credibility of your study are enhanced.
Ensuring Your Research Is Legally and Ethically Correct: Our team ensures that your research meets the most stringent ethical and regulatory requirements, while at the same time safeguarding your subject’s rights to privacy and your institution’s confidentiality regarding data and results.
We Follow Global Standards: At Statswork, we follow multiple global regulatory and ethical standards, including ICH-GCP, FDA, EMA, HIPAA, and others, so that you can be confident that your research project will satisfy all of the legal and ethical requirements from the study design through to the final publication.
Efficient and Fully Legal/ Ethical Study Executions: By having compliance integrated into your research study, our team will ensure a more efficient study execution by minimizing risks of non-compliance, errors, and defense of your study results during the peer-review process and while defending your findings in the publication process.
1. Custom Compliance Frameworks
We build a customized compliance framework for each study to ensure that every aspect of the study, including the design, data management, etc., is compliant with ICH-GCP, HIPAA, and the FDA and EMA.
2. All Stages of a Study
We include ethical guidelines and regulations in every phase of a study to protect the rights of subjects and ensure that the subject's data is private.
3. Regulatory and Ethical Compliance
We will make sure that your study meets current regulatory and ethical compliance requirements. This will reduce the likelihood of problems with non-compliance and enhance the credibility and defensibility of your study under the regulations of your jurisdiction, as well as those of other jurisdictions.
4. Review and Improve Your Compliance Framework
Statworlds will review and improve your compliance framework to ensure that it meets standards and is as efficient as possible. This will enhance the credibility of your study.
5. Ongoing Compliance Guidance
Statworlds provides ongoing compliance support for the entire duration of your study, providing continual guidance on how to maintain compliance with changing regulatory and ethical requirements.
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