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*Please note that we are a research service provider, not a pharmacy or clinic, so we are unable to see patients and do not offer diagnostic and treatment services for individuals.

Data Management Services

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Data management encompasses the methods and tools that are implemented to collect, process, safeguard, and assess the data produced during the clinical research process. The data management services provided by Protheragen cover all the essential aspects needed in clinical research.

Introduction to Data Management

The process of data management is key in any clinical research as it guarantees that the data which is obtained in any clinical trial is kept accurate, secured, and valid. Additionally, clinical data management entails enhanced deep analytical processes which include data collection, data validation, deduplication, and cleaning. The reliable data that is produced through valid statistical measures forms the basis of further innovation in drugs and medical devices and this data can be achieved through efficient data management.

Historical evolution timeline of pharmacovigilance. Fig.1 Workflow of big data analytics. (Dash S., et al., 2019)

Data Management in Clinical Research

In relation to research, data management systems possess certain purposes. These include:

Maintaining reliability and validity of data: Collecting reliable data and further reaching concluding remarks from that data is crucial. Data management services undertake certain mechanisms to decrease discrepancies.
Streamlining Decision Making Process: Efficiently going through each phase of a clinical trial enables faster decision making which ultimately makes the drug development process faster and makes the patients safer.
Data Integrity: Always being on the lookout during the process of data collection guarantees integrity, which allows for stronger statistical testing and drawing better conclusions regarding the safety and efficiency of a drug.
Privacy Protection: Guarding sensitive patient information is essential. Data management services conduct themselves in a manner that meets the requirements for regulation and data privacy.
Audit Trail Maintenance: Data integrity is ensured by setting an explicit audit trail for every raw data, altered, and analyzed during the clinical trial, and any faults are corrected.

Our Services

Protheragen offers a wide array of data management solutions which meet the high standards sought after by clinical research. As part of our service, we make certain that all data management procedures, including the design of a study, are completed to perfection.

Electronic Data Capture (EDC) Systems

Protheragen employs modern EDC systems in collecting, managing and electronically storing clinical trial records. Through these systems, timely data input is performed which reduces chances of error. Key features include:

Customized Electronic Case Report Forms (eCRFs)
Quality Check Processes
Integration Capabilities
Query Management
Data Export Reports

Clinical Trial Management Systems (CTMS)

With our CTMS platforms, we take a holistic approach to address all aspects of clinical trial management. The following core features include:

Study Management Tools
Recruitment Trackers
Multi-Site Management
Compliance Checks
Centralized Data Repository

Data Standardization Services

Protheragen puts a high value on data standardization which ensures data quality and consistency across all of the clinical trials. We apply leading industry data standards like CDISC models. We also offer services such as:

CDISC Standards Implementation
Data Interoperability
Regulatory Submission Preparation

Data Analytics and Visualization Services

Protheragen leverages excellent statistics as well as machine learning so as to facilitate clinical trials visualization and analytics. To be specific, we offer:

Predictive Modeling
Dynamic Dashboard
Study Design Optimization
Statistical Analysis

As a result of optimizing data collection and processing activities, Protheragen's services reduce duplicated efforts and automate certain processes which result in great cost reduction. Our accurate data management enables study teams to use more resources for patient interaction and adherence to protocols. If you are interested in our services, please feel free to contact us.

Reference

Dash, Sabyasachi, et al. "Big data in healthcare: management, analysis and future prospects." Journal of big data 6.1 (2019): 1-25.