Clinical Data Management
Why Data Management is essential for clinical trials
Clinical trials produce vast amounts of sensitive and high-quality data, which requires an efficient data management solution that covers all aspects. To ensure that the research’s conclusions are well-supported, the clinical data management system must guarantee that the collection, availability, and integration of data meet appropriate quality standards and are within the stipulated cost.
Clinvigilant EDC seamlessly transforms data recorded on paper into an electronic case report form (eCRF), that can be used for both simple and complex trials in all phases of the research.
As an in-house platform, the EDC is cost-effective and customizable for different types of budgets. Moreover, the solution helps in achieving better outcomes and offer the following advantages:
EDC systems streamline the data collection process and allow access to research data from virtually any device.
Increase efficiency with real-time data access. Cloud-based data simplifies the analysis process at the end of the study, saving significant time and effort spent on query management. Additionally, user-friendly navigation and search options allow for more accurate data filtering and retrieval. Key features such as a customized dashboard, KPIs, site performance, 360-degree patient data entry view, adverse event monitoring, and remote monitoring improve visibility.
The solution integrates and harmonizes data from multiple sources by connecting all clinician, patient, and device data at an individual record level. ClinVigilant’s EDC system directly integrates eSource, eCRF, ePRO/COA, as well as laboratory and device data. Integrated with ETMF, the solution ensures maximum Patient Engagement while prioritizing Informed Consent.
Hierarchical permissions based access, HIPPA-compliant, 21 CFR Part 11, ICH-GCP and GDPR, with a wide range of security features to protect data along with robust backup options to recover and restore critical information. The user-friendly data entry forms from ClinVigilant’s EDC empower users to enter data rapidly while ensuring accuracy. It reduces database lock delays by leveraging direct input validation, edit checks, and auto-calculation formulas to capture only clean study data.
Drive Value with ClinVigilant’s End-to-end Data Management Solutions
Our databases have been devised to achieve precise endpoint specifications, and furnish fundamental attributes mandatory for the fine-tuned calibration of tailored regulatory report outputs. We present a comprehensive Data management solution, purposely crafted for your needs, that features the following specialized services:
It begins with the definition of all the aspects to be examined, and reaches completion with the final interpretation of the results. With the help of ClinVigilant’s in-house EDC platform the entire process takes less than four weeks.
Clinical data validation aims to ensure the quality and integrity of data. Specifically, it focuses on the four key characteristics of clinical data including the source-related attributes, human readability, originality, and accuracy. To ensure accuracy and quality, we validate the data entered through both manual and automated processes
Our systematic coding workflows transform your research’s diagnosis and procedures into useful universal medical alphanumeric codes. Even the heftiest medical reports are translated and summarized into efficient, data-friendly codes.
Streamlined build approach
We also specialize in Electronic Case Report Form (eCRF) design using CDASH and CDISC. The eCRF-based internal template library of CRFs enables accurate and human-readable entries for cleaner data.
Rapid EDC deployment
ClinVigilant can deploy eCRF as quickly as within four weeks (including completion of UAT) thanks to our in-house Clinical Data Programmers
CDISC Study Data Tabulation Model (SDTM)
Following the database locking, SDTM data sets provide the standards for organizing clinical trial data and define the way in which individual observations from a clinical study are compiled.
The data generated across the multiple phases of a clinical trial must be submitted on a continuous basis to regulatory agencies like FDA. You can utilize our conversion services to aggregate, clean, and convert your clinical data from proprietary formats to the standards prescribed by the agencies.
Serious Adverse Event (SAE) reconciliation
The SAE information for both interventional and non-interventional is captured in two distinct databases. While the adverse event information is recorded in the Case Report Form (CRF) database, the safety database contains information collected on the SAE Form. Our expertise in reconciliatory services pertaining to SAEs ensures optimal data quality, operations performance, and compliance.
Our data management solutions focus on data cleaning, including query management and listings review, and comply with SOPs and protocols to meet the required regulatory and organizational policies. Our custom-built reports are tailored to each individual trial, while a standard set of reports are tailored to Clinical trials.
Get smart with your decision process using a rational approach
An Interim analysis can help you adopt a practical approach to assess and forecast the results of a clinical trial based on the insights gained during the study
Given the extraordinary size and complexity of clinical trials, the approach not only allows you to measure the main endpoints continuously but also share well-organized data output with biostatisticians and other stakeholders in a timely manner. We enable you to perform test exports and analyses of protocol-specific data well before interim analyses, which ensures all pieces of the jigsaw fall in place before the crucial moment.