Top 7 eQMS Solutions for Clinical Trials

eQMS software for quality management in clinical trials

A clinical trial is already a lengthy, complex process that takes several years to complete as it goes through numerous phases, including initial study designs, IRB approvals, participant recruitment, and final data assessments.

If there are problems due to ineffective quality control at any clinical trial stage, operations can be halted in their tracks, leading to further delays that cost a drug development endeavor time, resources, and money.

However, with a quality management system (QMS), sponsors and CROs can mitigate the risk of quality issues before they arise, streamlining clinical trial operations from start to finish.

Many other sectors in health sciences, such as healthcare institutions, pharmaceuticals, biotech firms, and medical device manufacturers, have already adopted QMS or eQMS software with much success.

Therefore it stands to reason clinical trial stakeholders can find similar success from utilizing an eQMS solution not only to optimize processes and avoid delays but also to uphold regulatory standards critical for furthering drug development.[¹]

In clinical studies, a quality management system typically helps manage a variety of complex documentation, such as trial protocols, participant information, audits, and guidelines.

However, QMSs vary, offering different features and facilities, and not all benefit every clinical trial. For example, a standard QMS will deal with paper-based records and documents that are easier to understand and manage but prone to human error. Furthermore, sponsors and CROs may struggle with paper-based QMS solutions as it is harder to maintain transparency and traceability. Additionally, there are issues with access, loss of documents, storage, auditing, and lengthy authoring process.[²]

On the other hand, an eQMS (electronic quality management system) takes away the hassle and headache of outdated paper-based systems by providing a digital solution via software to facilitate quality management.[²] With an eQMS, teams can easily share, review, and track their documentation in real-time as the trial progresses. Furthermore, sponsors can oversee operations to ensure all regulatory compliance guidelines are followed as necessary.[³]

With automated checks and electronic signatures, electronic quality management systems maintain the integrity and consistency of a clinical trial, keeping trial site staff accountable. Additionally, it is less prone to human error and allows for better communication and transparency [²],[³]

Other advantages of electronic quality management systems include the following:

Increases efficiency and reduces overall operating costs
Assist compliance with standard regulations and guidelines, such as ISO 13485:2016, FDA 21 CFR Part 820, ICH Q10, etc.
Help meet customer requirements by designing products and protocols that are safe, effective, and meet regulatory standards.
Automate manual processes such as managing and tracking workflows, documents, and data.
Simplify the informed consent process through electronic signatures.
Generate automated reports that highlight trends and pinpoint areas that require improvement.[⁴]

It is important to note that eQMS also stands for enterprise quality management system, a broader term used by large pharma companies that sponsor multiple clinical trials. Electronic QMSs play a small role in an enterprise system.[⁴]

What to look for in an eQMS software solution

Organizations with multiple documentation types, spreadsheets, and other software programs to manage operations can benefit from eQMS software. Additionally, a lack of communication, repeated human errors, and the inability to comply with regulatory standards also indicate the need for an eQMS software solution in a clinical trial.

Given the number of solutions available, it is important to understand which ones fulfill your requirements and have the quality management features to supplement your research work. Thus, we have compiled a list of must-have features you must look for before investing in an eQMS for your clinical trials.

Built-In Regulatory Compliance – Regulatory guidelines and standards are known to grow in number and complexity, making it tedious to keep track of them as they are updated. An eQMS software with built-in compliance is pre-configured from the start, allowing you to store and share information in a single location accessible to auditors and the quality team. Moreover, solutions that comply with FDA 21 CFR Part 11 provide patients with remote consent and re-consent facilities that remove the problems associated with commuting and travel restrictions.[⁴],[⁵]
Risk Management - An eQMS that also covers risk management provides a safety net to catch the human errors that are known to plague paper-based quality management systems.[⁵]
Deployment method- how an eQMS is deployed given a trial site’s current system is another crucial aspect sponsors need to consider. For instance, is a cloud-based or non-cloud-based system more suitable for your study needs? While a cloud-based system is easier to manage and doesn’t require additional equipment, it may be susceptible to unverified access. On the other hand, a non-cloud-based eQMS is more secure but requires special hardware and staff to manage and keep it up-to-date with the latest technology.[⁴]
Pre-Validated - an eQMS with pre-validation ensures your system and software comply with the FDA requirements. Moreover, pre-validated eQMS software saves money and resources as a developer has already undergone the time-consuming validation process.
Statistical Process Control (SPC) - eQMS software with SPC provides advanced data-modeling tools to measure and control underutilized resources. Additionally, SPC helps organizations make intelligent decisions backed by data regarding process control and equipment issues.[⁵]

Conclusion

Every clinical trial is burdened by an excess of documentation, planning, scheduling, and managing multiple operational workflows that become increasingly overwhelming as the complexities of a study increase.

While quality managers are responsible for generating, tracking, and analyzing all workflows and reports to ensure the trial’s objectives are met, it can be bogged by human errors when these tasks are handled manually. And these Substantial errors can lead to costly delays.

However, with eQMS software, all these manual, error-prone tasks can be digitalized and automated, making it easier to maintain quality and compliance.

Having said that, it is important to understand the requirements of your trial site and study to ensure you have the right electronic quality management system handling operations.

Therefore, it is vital to ensure a potential eQMS has all the features you need and is easily integrated with other existing data management systems while remaining within budget.