Overview of Data Management in Clinical Trials
Table of Contents
Clinical trial data management (CDM) is the process of gathering, cleansing, and maintaining subject and study data following internal procedures and regulatory standards for a program or research. It is the first phase of a clinical trial, a field of study, and an aspirational model.
Clinical studies can advance with appropriately obtained data, resulting in accurate, high-quality, statistically suitable results. In addition, proper data collection reduces the period between drug development and marketing.
A multidisciplinary team, including research nurses, clinical data managers, investigators, support employees, biostatisticians, and computer programmers, is also needed for appropriate data collection.
During the trial development phase, data managers put up clinical studies. Primary data sources include site medical records, laboratory reports, and patient diaries. Staff members must transcribe paper-based CRFs before entering the source data into a clinical trial database. They double-enter paper-based forms and compare them, as is recommended practice. This method reduces the number of data entering errors dramatically. Staff can add source data directly into the database via electronic CRFs (eCRFs).
Like any other enterprise, clinical trials have a limited budget and personnel resources. Therefore, it’s critical to develop and follow a robust data management plan that includes a structure for research workers, resources, and storage. In addition, a clinical study entails a significant time, human, and financial commitment. Therefore, from the beginning, it needs competent management.
Data Management Solutions That Are Both Flexible and Customised by Element Technologies
Approach to Consultation
In all data management operations, we use a consultative approach for clinical trial database management and clinical data services. We’ll collaborate with you to determine your long-term objectives and give expert advice on how to get there quickly and effectively. As a result, our methods are adaptable, yet they still provide a solid foundation for data management.
Based on your current projects and your future pipeline, we will discuss with you early to select the best clinical data services & solutions for you. We can help you match short-term goals with the long-term vision for your programs and plan ahead of time for each step.
We’ll walk you through the most significant aspects of data management and how each one affects other stakeholders. We recognize that not every person is an expert in data management. Therefore, we work hard to meet operational goals and teach and support you along the way.
A Proactive Data Management Strategy for Clinical Data Services
Each aspect of data management is supported by our processes, which encourage a proactive approach. Case Report Forms are developed from the ground, up with the help of our in-house library of forms. Data cleansing is done as close to real-time as feasible to enhance query success rates and discover difficulties early. On a rolling basis, the database is locked in the clinical trial database management system.