Post authorization safety studies (PASS)
RemedyBytes excels in providing full end-to-end service for non-interventional register-based post authorization safety studies (PASS) in partnership with pharmacovigilance services provider Tepsivo.
We have a deep-seated expertise in healthcare databases and healthcare systems, particularly within the Nordic countries — Denmark, Finland, Sweden, and Norway.
Although our core strength lies in the Nordics, our capabilities extend across Europe, where we manage, analyze, and report study data through an integration of modern software solutions, innovative methodologies, and a stringent quality management system.
Study Protocol Development and Execution
RemedyBytes specializes in the retrieval and analysis of data from healthcare registries throughout Europe.
Our bread and butter is to support our customers to identify the data crucial for achieving your study outcomes. This includes formulating a data collection strategy and a comprehensive Statistical Analysis Plan (SAP) ensuring that your safety study succeeds.
We take on the authorship of the Study Protocol, ensuring the retrieval of data from diverse European national health registries, encompassing hospital and pharmacy records, insurance databases, and other essential healthcare registries.
Our service includes providing information on data accessibility, procedural subtleties of registries, and anticipated costs and timelines.
After the Study Protocol finalization, we contact the relevant registries, submit the applications or retrieve the data from the source.
The collected data is consolidated into a database, where it is cleaned and validated as necessary.
Role of Principal Investigator
RemedyBytes can act as the Principal Investigator on your behalf or we can support the Sponsor and Principal Investigator by assigning a Responsible Person for PASS.
This role can include a large majority of responsibilities, as agreed, to ensure smooth conduct of the study.
Study Report Authoring
RemedyBytes will author the Study Progress Reports, the final Study Report, and the abstract and article, if scientific publications are part of the plan for the PASS.
We have a team of skilled experts, including Principal Investigator, Responsible Person for PASS, Account Manager and external consultants, to author the documents as agreed with the Sponsor.
Study Report Authoring
Data Collection, Handling and Analysis
RemedyBytes uses a unique set of modern validated software for the data collection. This includes a platform solution for centrally storing all the study information in one unified destination.
The platform connects to a set of specialized databases where both the study data and the safety reports collected during the PASS can be stored in their native format.
RemedyBytes has well-defined processes for the storing and handling of the study data. During the study development phase the types of data, data storage modalities and data management processes will be defined, and described in the study protocol.
The platform and database technologies used by RemedyBytes ensure that all the data will include identifiers and that all the activities related to creating, editing and deleting data will be recorded in a comprehensive audit log.
The data handling processes describe how the required information will be derived from source documents. All data will be stored safely in confidential conditions using software with comprehensive validation documentation.
RemedyBytes follows the generally accepted guidelines for statistical principles for study data analysis. The general process for data analysis is immediately available and the study specific data analysis process is described during the planning and designing the study protocol.
Regulatory Engagement and Submission
RemedyBytes takes care of the application and registration process using the required methods, whether it is with CTIS, EU PAS or direct communication with the EMA or national competent authorities.
Our communication with regulatory bodies is clear, concise, and conducted in the native language to preclude any miscommunication or delay.
Safety Data Collection and Reporting
Together with Tepsivo we offer a seamless approach to safety data collection, analysis, and reporting, utilizing in-house software that is integrated with our central data storage systems. This methodology ensures streamlined operations, adherence to regulatory standards, and impeccable data integrity throughout the PASS.
Safety Data Collection and Reporting
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