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Clinical Data Management: A Complete Guide

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Data management is a fundamental part of healthcare. But the sheer volume of data being generated by hospitals, labs and clinics makes it difficult for people both within and outside the industry to make sense of this information.

A recent paper from a team at Duke University shows just how easy it can be for these organizations to miss valuable opportunities – missing shifts in public health trends or short-term changes in patient care that could lead to long-term problems.

What Is Clinical Data Management

Clinical data management (CDM) is a critical aspect of patient care, one that can have a significant impact on patient outcomes. But it is also an area that is often neglected. And there are many reasons for this – from a lack of “buy-in” from the rest of the organization to the fact that CDM isn’t even recognized as a separate function.

Medical Data Management Program The market size was USD 1,996.6 million in 2021, and it is anticipated to increase at a CAGR of 11.4% from 2022 to 2030.

But make no mistake – CDM can be an extremely valuable business function. And one thing is clear: It works best when it’s embedded in other parts of the enterprise, rather than being considered its own entity or business unit.

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Clinical data management has four primary business processes: generating and tracking data, assisting in developing solutions, improving patient care, and coordinating with others.

In addition to these processes, it’s also important to have a detailed plan for how the clinic will manage its data. That’s because your actions affect multiple functions across the organization.

CDM can also be implemented through “clusters of care” or “clusters of technology” – two methods that allow clinicians to implement CDM without having to create a new business unit or department.

Importance Of Clinical Data Management

Unlike many other facets of healthcare, CDM is one of the few that has a direct impact on patient care. It’s not a matter of finding ways to reduce costs but of finding ways to improve them – and improve the quality of patient care as well.

According to ClinicalTrials.gov, there were 387,363 clinical trials registered studies globally as of August 2021.

As new technologies are introduced and new systems are developed, it’s important that they also have a foundational understanding of clinical data management and what it means for the organization.

For example, as genomic testing becomes more widespread, data storage needs will inevitably rise. Organizations will need to find ways to keep pace with growth in order to ensure that patient care remains optimal.

Benefits Of Clinical Data Management

The clinical data manager is responsible for the management and coordination of clinical trials. This includes the data entry, electronic data capture, and data validation of clinical trial data. The clinical data manager also ensures that the data is accurate and complete, and that it meets the requirements of the sponsor.

The market for cloud-based (SaaS) solutions reached USD 1.1 billion in 2021 and is anticipated to expand at a sizable CAGR during the projected period. The Data Management Plan (DMP) is a document that outlines how data will be collected, managed, and stored during a clinical research study.

The data manager is responsible for creating and maintaining the DMP. A Clinical Data Management System (CDMS) is a software application that is used to collect, manage, and store clinical trial data.

1. Improved Patient Care

The data and knowledge that are gathered through CDM can be used to improve patient care on an ongoing basis. This allows for better results in every area of CDM, even those that seem unrelated. For example, data from patient notes and lab tests can be used to improve a medication-related CDM process.

2 .Increased Operational Efficiency

CDM helps the organization improve the way it works internally. That means it can have a significant impact on operational efficiency, helping the business save money and resources – which then gets passed on to patients and customers in the form of lower prices or increased service.

What’s more, transparency across the organization is an important aspect of any successful CDM program.

3. Improved Public Perception

During the projection period, the contract research organisation (CRO) segment is anticipated to increase at a faster rate of 12%. CDM is a critical component of any public health strategy.

For that matter, it’s also an important aspect of the organization’s image. When done correctly, CDM can have a measurable impact on patient and customer perception – which can have a significant impact on how much they are willing to pay for services and products.

4. Increased Data Security And Privacy Protection

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Data security is another must-have CDM requirement – one that must be addressed at the earliest stages of the process. However, this is often overlooked because data security isn’t necessarily part of the overall plan for CDM operations.

But the fact is that bad data management practices can lead to loss of sensitive information and more frequent security incidents. Here’s how CDM can help prevent this from happening.

5. Reduced Cost Of Management

CDM can have a significant impact on the cost of management as well as personnel, operations and overhead. The right CDM toolset, processes and strategies will help organizations improve their overhead costs and reduce the need for new hires or additional management positions in order to streamline the business process.

6. Increased Collaboration Across The Enterprise

It’s no secret that a lack of collaboration across departments and functions within healthcare has been one of its biggest challenges over the years. CDM facilitates this kind of collaboration by bringing people together who may not have worked together before.

But CDM is more than that – it’s an opportunity to leverage the data and information that other parts of the organization have already generated, making CDM a vehicle for collaboration in action.

7. Increased Efficiency On A Macro Level

When done right, CDM not only improves efficiency in the business process being analyzed – but across enterprise-wide operations as well. CDM gives organizations a new way to improve their overall performance, which can lead to increased profits.

For example, it can be used to reduce recall rates for medications or medications with adverse side effects that could be related to data management processes.

8. Reduced Risk Of Tampering Or Fraud

No matter how strong the security is, it’s possible for confidential data to be leaked or hacked, which can have a significant impact on the organization’s reputation and operations when it occurs.

The key to preventing data leaks and hacks is making sure that all relevant systems and processes are reviewed at least once per quarter. In addition to this, organizations must include regular penetration testing as part of their CDM plans.

Risks Of Clinical Data Management

Clinical data management (CDM) is a process used by clinical research organizations to ensure the accuracy, completeness, and quality of clinical trial data. Clinical data managers (CDMs) are responsible for overseeing the CDM process and ensuring that data is collected, processed, and analyzed correctly.

The CDM team is typically composed of statisticians, data analysts, and other experts who work together to ensure that data is of the highest quality.

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The clinical data management workflow is a process used by clinical trial sponsors and clinical research associates to manage clinical data.

Clinical data management systems are used to store, manage, and analyze clinical data. Human clinical trials are conducted to evaluate the safety and efficacy of new drugs or medical devices.

1. Everything Is Data

Due to the substantial presence of well-known pharma & biopharmaceutical companies as well as CROs, North America accounted for 46.5% of the worldwide clinical data management systems market in 2021 and is predicted to maintain its dominance during the forecast period.

In reality, it’s not possible to get away from the fact that everything in healthcare is about data.

2. Lack Of Credibility Among Physicians

It’s not uncommon for physicians to be skeptical of organizational initiatives that don’t directly affect them – particularly when they think the initiative is misguided or unnecessary.

But CDM can go a long way toward establishing trust with physicians by helping them make informed decisions and providing better patient care through a variety of methods.

As such, it may require an educational component – perhaps on an ongoing basis – to establish proper channels of communication between practitioners and organizations as well as other stakeholders.

3. Lack Of Data To Support Clinical Decision-Making

One of the biggest challenges in CDM is getting enough data to properly draw conclusions and make informed decisions about patient care. Data is only as good as the information it’s based on, and that includes most healthcare providers’ ability to collect accurate, up-to-date information from multiple sources.

4. Lack Of Tools To Support Enterprise-Wide Analysis

It may seem obvious, but there is a growing need for better tools and resources that can help accelerate analytical insights across the organization. Tools that reduce the time it takes to complete complex data processing projects and also improve the quality of insights being generated will have a noticeable impact on performance.

5. Misuse Of Data

Any system is only as good as the information it’s based on, and that includes healthcare. That means any misuse of data could have a significant impact on patient care through false assumptions or misinterpretations.

This means organizations must work to develop better standards for collecting, storing and retrieving data in their CDM initiatives. In addition to this, they must also invest in enterprise-wide monitoring tools that can help detect potential issues before they become problems.

6. Lack Of Data Security Or Data Loss

Ennov purchased MACRO from Elsevier in April 2022. MACRO was a supplier of sophisticated EDC (Electronic Data Capture) software for clinical research.

Data security is critical in today’s increasingly cyber-centric world. That’s why it’s vitally important that all organization-wide initiatives embrace a holistic approach to cyber risk management and have established a plan for addressing them – including CDM efforts.

7. Slow Data Storage And Retrieval

One of the most frustrating things about CDM is dealing with outdated or inaccurate data. It could be difficult to generate actionable insights when the information being used is out of date or inaccurate.

This means it can be tempting to abandon the initiative altogether, but it’s important to keep in mind that many organizations are still working on setting up their CDM process, so there will likely be some bumps along the way.

8. Need For Infrastructure Investments And Maintenance

No matter how robust your infrastructure may be, there will always be things that need to be done – especially during renewal cycles – which can lead to slowdowns in processing and reduced efficiency across the board.

Final Note

As organizations are forced to adapt to an increasingly complex healthcare environment, CDM is expected to become more important than ever in the coming years.

Given the growing volumes of data being generated and managed by healthcare organizations, it’s likely that CDM initiatives will need to evolve over time in order to meet today’s expectations for improved performance and reduced costs.

Last Updated on October 13, 2022 by Parina Parmar