EDC & Data Management

Why Data Management is essential for clinical trials

As clinical trials generate massive amounts of sensitive and high-quality data, streamlining it requires a proficient data management solution that covers all the bases. To ensure the conclusions drawn from the research are well supported, the clinical data management system has to make sure the collection, availability, and integration of data is of appropriate quality and within stipulated cost.

How EDC System can transform your research

Research organizations looking to leverage new technologies for clinical trials are fast realizing the advantages of Electronic Data Capture (EDC). When using EDC, the research data recorded on paper is transcribed into the system and saved in an electronic case report form (eCRF), and can be adopted for both simple and complex trials in all phases of the research.

Key advantages

The cloud-based EDC from ClinVigilant provides highly configurable capabilities to create the paper CRF to eCRF by using the proprietary Institutive eCRF designer tool. No programming skill is required to create, deploy and manage the study database, making it quite easy for researchers to capture high-quality, reusable data.

EDC in clinical trials has become one of the most preferred options to collect, clean, store, transfer, and process data. The EDC solution from ClinVigilant allows for virtual clinical trial, where the data is directly captured into the system. As part of the solution ClinVigilant even manages the source data electronically into the system, which gets fetched into the e-CRF directly. It not only eliminates the use of paper completely but also considerably reduces the efforts of SDVs.

The EDC from Clinvigilant ensures faster study deployment as it significantly reduces the time spent on building and managing studies. Be it single center or multicenter studies, managed sites, CDASH-CDISC form template builder, advanced user management, workflow, scheduling, or rule configuration, the system has the capability to streamline the data captured for all types of clinical trials.

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:

Accessibility

EDC systems streamline the data collection process and allow access to research data from virtually any device. Of course, the device has to be authorized, and users have to enter the right credentials to access the data. However, the process is much faster as compared to paper-based forms, and is able to make data easily available to data reviewers

Integrated Solution

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.

Efficiency

The real-time access to data makes EDC quicker and efficient. The easy availability of data simplifies the data analysis process at the end of the study. It also saves a significant amount of time and effort spent on query management. The user-friendly navigation and search options help in finding and filtering data with much more accuracy. Key features like customized Dashboard, KPIs, Site Performance, 360 degree Patients Data Entry view along with Adverse Event Monitoring and Remote Monitoring help improve visibility.

Security

The user accounts in EDC systems have designated permissions, and most actions can only be carried out by certain roles. As the system is HIPPA-compliant, 21 CFR Part 11, ICH-GCP and GDPR, it has a wide range of security features to protect the data from breaches 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

Focusing on the ultimate goal of calculating the primary and secondary endpoints with accuracy, our databases fulfill the essential baseline attributes required for specialized configuration of regulatory report outputs. Check out our comprehensive and customized Data management solution that includes the following services:

Database design

As a multi-stage process, the complex process of designing the database 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.

Data validation

Performed as a series of documented tests of the data, clinical data validation aims to ensure the quality and integrity of the data. Specifically, it focuses on the four key characteristics of clinical data including the source-related attributes, human readability, originality, and accuracy. By focusing on the correctness and completeness of the data, we validate the entered data through both manual and automated processes to ensure its accuracy and quality.

Medical coding

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

Through our proven strategies and technologies for express development, implementation and management, we optimize the delivery process to save time and money. With an in-house data programmer and its own EDC platform, ClinVigilant can deploy eCRF as quickly as within four weeks, including completion of UAT.

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.

Conversion services

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

To incorporate what is learned during the course of a study, you need a realistic approach to analyze and predict the outcomes of a clinical trial, which can be achieved through Interim analysis.

Given the extraordinary size and complexity of clinical trials, the approach not only allows you to measure the outcomes of interest 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.

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