Clinical trials are inherently a challenging undertaking, involving several key stakeholders, including patients, principal investigators (PIs), sponsors, and contract research organizations (CROs), all working to ensure the investigational drug’s safety. During this process, a massive volume of data is generated and must be rigorously monitored for the duration of the clinical trial to maintain the quality and integrity of its results. From patient information to complex trial outcomes, data management services serve this exact purpose, offering a comprehensive array of tools and approaches to capture, clean, validate, and analyze data with the utmost precision and security.

Although often not the most publicized component of the drug development process, data management is the foundation on which evidence-based knowledge of new drugs and medical devices is collected. This article explores the top data management services that ensure accurate, secure handling of clinical trial data in compliance with key regulations. Read on to learn how CROs like TFS HealthScience are revolutionizing modern trial data!

 

The Integral Role of Data Management in Clinical Trials

There are five main objectives of data management that underscore the importance of these services within clinical research, as described in this article:

1. Ensure the data collected from a study is accurate to promote reliable results and conclusions.
2. Efficiently manage data through each phase of a clinical trial to facilitate faster analysis and decision-making, as well as safer drug testing.
3. Continuously monitor data collection for completeness to enable robust statistical analysis and accurate conclusions about a drug’s safety.
4. Maintain the highest security to protect sensitive patient health information in compliance with regulatory and data privacy regulation requirements.
5. Establish a clear audit trail of all data collected, modified, and analyzed during a clinical trial to uphold data integrity and allow for easier detection of discrepancies.

Ultimately, clinical data management services are crucial in clinical trials because they ensure the generation of high-quality, reliable, and statistically sound data, while ensuring patient safety, regulatory compliance, and cost efficiency.

 

Electronic Data Capture (EDC) Systems

First and foremost, one of the most important data management services CROs will provide in clinical research is maintaining the study’s electronic data capture (EDC) system. An EDC platform is a computerized system used in clinical trials to collect, manage, and store data electronically rather than using traditional paper-based methods. It allows clinical research coordinators (CRCs) and other investigative site staff to enter patient data in real-time throughout a trial. This digital approach offers lower chances of data errors than paper-based data collection, while reducing any costly delays between data collection and analysis.

There are several EDC systems on the market for sponsors to consider for their clinical trials, but they typically share the same key features. These include customized electronic case report forms (eCRFs) designed around a study’s unique protocol to ensure standardized data records. These eCRFs will also have built-in quality check processes which quickly flag any data inconsistencies or outliers. Other common features include integration with separate digital systems designed for randomization or trial drug supply management, direct communication between CRCs and data managers through query management processes, and easily accessible data export reports to inform data-driven decision-making.

TFS offers robust EDC system management and real-time review to uphold data integrity for your Phase I to Phase III clinical trials. Visit the TFS Solutions page to learn more.

 

Clinical Trial Management Systems (CTMS)

In 2022, the clinical trial management systems (CTMS) market was valued at US$2.3 billion and is expected to grow at a compound annual growth rate (CAGR) of 11.2% from 2023 to 2032. A CTMS is similar to EDC systems in that it is a specialized software platform for managing, storing, and analyzing data. However, it goes beyond just data capture, offering additional features that allow sponsors and CROs to manage the entire lifecycle of a clinical trial.

Most CTMS platforms typically include several of the same core features:

• Study management tools for budget planning, protocol oversight, and milestone tracking
• Recruitment trackers reporting patient enrolment, potential participant screening, and patient status throughout the study
• Multi-site management tool to promote effective communication and coordination between the sponsor or contracted CRO and all investigative sites in a clinical trial
• Built-in compliance checks according to local and international regulatory guidelines, including Good Clinical Practice (GCP), the International Council for Harmonization (ICH) guidelines, and the Food and Drug Administration (FDA) regulations
• Platform that acts as a centralized repository for stored study data with audit trails, real-time updates, and accessible report generation

Clinical trials that utilize a CTMS for centralized study and data management benefit from greater cost savings from the efficiencies introduced by this system’s various tools and trackers. Redundancy in data entry tasks are eliminated, while the automation capabilities of a CTMS allows study teams to divert more valuable resources toward patient care and protocol compliance. Like an EDC, CTMS also provides improved data quality and integrity, as well as real-time access to trial data to facilitate faster clinical decisions and earlier detection of potential problems.

 

Data Standardization Services

With the increasing globalization of clinical trials and the need for data interoperability, standardization services have become common offerings from data management CROs and vendors. These services focus on implementing industry-dominant data standards such as CDISC (Clinical Data Interchange Standards Consortium) models, as well as emerging data formats presented in the FHIR^® (Fast Healthcare Interoperability Resources^®) and the OMOP (Observational Medical Outcomes Partnership) CDM (Common Data Model). The purpose of these data standards is to improve data quality and maintain consistency between clinical trials, allowing for more inter-study analyses.

Depending on the region, CROs that offer data standardization services may also collaborate with key professional organizations in the industry:

• The global Society for Clinical Data Management (SCDM)
• The Association for Clinical Data Management (ACDM) in the United Kingdom
• The Drug Information Association (DIA)

Data standardization services offer several advantages, ranging from improved data comparability between different studies and more robust meta-analyses to cost savings from streamlined data preparation for regulatory submissions. By supporting sponsors with dataset mapping according to CDISC standards, CROs with these services can help accelerate regulatory review and drug approval.

Discover how TFS CRO’s Strategic Resourcing Solutions (SRS) can find expert data managers who deliver cost-effective solutions for your data management needs. Learn more here.

 

Data Analytics and Visualization Services

The ability to gain valuable insights from the large volume of complex data collected in clinical trials lies in data analytics and visualization services. Experts in these teams employ advanced statistical techniques and even machine learning algorithms with predictive modeling capabilities that can help researchers identify potential safety signals or efficacy trends early in the trial process. These can also be leveraged to present dynamic dashboards to present certain clinical trial information in more digestible formats (e.g., patient recruitment numbers, adverse event rates, etc.). Even before a clinical trial begins, researchers may also model several scenarios using these analytics platforms to decide on the optimal study design. The use of robust statistical analyses to understand trial findings is a pillar in evidence-based medicine, helping sponsors and CROs deliver the utmost data integrity in clinical research.

Did you know that TFS is the first CRO to implement Medidata’s new Detect data surveillance and risk monitoring platform? Medidata Detect is a centralized data analytics platform that offers a holistic view of patterns and discrepancies within a clinical trial. Learn more about this partnership here.

 

Conclusion

In conclusion, data management services are essential offerings from CROs like TFS and other vendors that ensure your clinical trial data is handled in compliance with all key regulations. From convenient digital platforms, such as the EDC or CTMS, to data standardization and advanced analytics, these services ensure all generated study data meets industry-standards for quality, integrity, and usability. Ultimately, these top data management services can help sponsors streamline their clinical trials, reduce costs, and enhance patient safety, while simultaneously accelerating regulatory review and even approval.

 

TFS CRO: Your Industry Partner in Data Management

At TFS HealthScience, we understand that strong data management is the foundation of a successful clinical trial. Our Data Management & Biostatistics team combine cutting-edge technology with seasoned expertise to deliver unparalleled accuracy and efficiency in clinical trials for clients worldwide. From study design to database lock, you can expect data integrity, compliance with regulatory standards, and seamless integration across all study phases. Our adaptive approach allows us to tailor our services to your unique needs, ensuring that your data not only meets but exceeds industry standards.

Ready to transform your clinical data management experience? Contact a TFS representative today or visit our website to learn what solutions we can offer for your next clinical trial!