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Clinical Data Management

Clinical Trials

We are dedicated to providing high quality clinical data management services to support your product development needs. Obtaining clinical trial data you can trust can save you time and resources. Proficient, active data management throughout the life of a clinical trial requires that data be:

·         collected in a controlled way;
·         verified for completeness and accuracy;
·         monitored for reportable events;
·         tracked for trend analyses (e.g., safety signals, investigator performance, etc.); and
·         exported for uniform results analyses.

Clinical Data ManagementWe use data integration tools to track your study progress across a myriad of metrics. This process  allows for constant monitoring of clinical study site performance and the ability to mitigate potential issues at an early stage. We create customized clinical trial progress reports to meet the needs of all your stakeholders. Our team performs appropriate statistical analyses to present clinical trial results that are meaningful and easy to interpret.

Electronic Case Report Forms (eCRF)

Web-based eCRFs are worksheets used within an EDC (electronic data capture) system to record clinical trial data in a logical way. Data entered into the eCRFs are mapped directly into the study database according to established standards (e.g., the Standard Data Tabulation Model, or SDTM) to allow for straightforward data analysis that satisfies regulatory expectations. We can create eCRFs that ask the right questions to achieve your clinical trial’s goals in a simple and intuitive way. These eCRFs are customized to suit the project type and individual requirements for streamlined data entry, avoiding the unnecessary delays and potentially inaccurate data that often result from poorly designed eCRFs.

Electronic Data Capture (EDC) System

An EDC system stores and organizes clinical trial data submitted directly by investigators. Drawing from our experiences working with hundreds of investigators worldwide, we are able to build efficient, intuitive EDC systems that are simple for investigators to learn and use. Clear data forms and simple navigation within the system promote:

·         efficient data entry;
·         more reliable, higher quality data;
·         increased investigator compliance; and
·         increased investigator satisfaction, which can significantly reduce clinical trial timelines.

We use real-time analytics and reporting tools to monitor the EDC system and actively manage clinical trial progress, data quality, and investigator performance. Continuous clinical trial monitoring is vital because certain data (such as serious adverse events) are subject to strict reporting requirements. Challenges to clinical trial progress and investigator performance can be identified quickly and resolved before they create a significant impact on the clinical trial timeline. Utilization of an EDC system in a clinical trial also increases efficiency by requiring legible data entries, enabling automatic calculations for cleaner data, and reducing queries about unclear responses.

The benefits of a well-designed, well-built MED Institute EDC system add up to minimizing the time and cost to run a clinical trial. Learn more about designing and building an EDC system in our “Considerations for designing and building an electronic data capture (EDC) system” blog series- Part 1: with users in mind and Part 2: with sponsors/CRO in mind.