Making Quality Management a Reality

Clinical Researcher—September 2021 (Volume 35, Issue 7)


Al O. Pacino; Matthew Chandler


The use of digital health technologies continues to be a viable solution for clinical research advancement. Many research leaders have considered adopting the use of quality management services in clinical research trials. Quality management systems (QMS) are at the forefront of incentivizing and implementing professional data handling. Administrators of clinical education and course learning should be open to exploring digital QMS options when it comes to the maintenance of student/staff records. Site leaders who need to be more aware of the specific capabilities, performance levels, and functionalities of their staff and facilities can turn to QMS for insights on the delivery of research training, connectivity, and security. Site managers and research staff can improve compliance, ensure protection of data, and scale up training standards that address the health outcomes of populations.

Modernizing Preparedness Leads to Compliance

Right now, digital-based training is applied and optimized in the search and design of innovative drugs, life-saving vaccines, and medical test devices. Additionally, care is being redesigned to address how patients are managed, diagnosed, and monitored for disease progression. As technological solutions advance scientific discovery, several sites are becoming more aware of the benefits of modern solutions for departments such as Human Resources and Quality Assurance.

Paper-based systems are becoming obsolete, as they are unable to maintain up-to-date information and struggle to realize total compliance. Hesitation appears to be steadily decreasing when it comes to the adoption of electronic-based QMS. When implementing or continuing the use of a QMS, it is important that all appropriate staff members are familiar with its capabilities. For this reason, a site should consider using an outlined protocol for the implementation of a QMS. The creation of a specific protocol for the system would also be beneficial, especially if an audit is performed at the site.

To demonstrate commitment to building site staff capacity, a multidisciplinary, digital management system can increase distribution, verification, and completion of required training. Having a learning management system (LMS) can be beneficial, but operationally, sites are required to comply in other areas aside from the training of staff members. QMS are now capable of offering a variety of other services that administrators should be aware of.

Internal evaluation is necessary since many systems on the market offer a variety of features which assist in the internal regulation of training, e-commerce, cross-department communication, and privacy standards. Systems that prioritize collaboration between educational institutions and research development for organizations can provide better access to continuing medical education (CME). Collaborative systems have resulted in the development of tools which update researchers about major diseases, indications, and therapies.

The delivery of systems that aid in compliance and implementation will generate more opportunities for everyone. The ability to adhere to new educational requirements, privacy laws, and efficiency standards creates more confidence between clinical research and healthcare institutions. Over time, both staff members and management benefit from efficiently managing end-to-end protected digital processes that leave no patient behind.

Leave No System Behind

Interoperability is one of the most important features for an effective QMS. This is the ability for products or systems to work with one another via a compatible interface. Newer quality management systems can be integrated into more siloed or single-purpose systems; for example, through application programming interface (API) connections.

A common question among managers and staff is whether connecting an LMS system with a more interoperable one is possible. Ideal QMS should be able to communicate with existing, more siloed systems. Copyright holders of certifications and broader education programs exist all over the globe. Therefore, it is becoming necessary for internal management systems to have education distribution abilities and global accessibility required for clinical research professionals. Sites need to consider QMS that can aggregate internationally to accredited and accurately translated clinical research courses.

To maintain business and operational success, management systems should have international reach and connectivity. Sites should also evaluate if their preferred QMS allows for increased ease of acquiring studies by having business networking functions and monitoring the study from start-up to completion.

Digital Priorities for Site Sustainability

When it comes to a site’s selection of a QMS, there are many factors to consider. Like the smartphones we use every day, we have come to expect certain features to be present. Some of the modern capabilities offered by QMS platforms are tools that enable privacy for individuals. As new laws regarding the digital handling of personal identifiable information go into effect across the globe, these tools are an essential feature for any QMS platform.

In accordance with the roll out of new privacy laws, professionals are being asked to own their personal identifiable information (PII). Allowing third parties to verify the authenticity of the information and sharing that information with global organizations for business and compliance purposes is becoming normalized. Innovation resolves the challenges that sites and sponsors face in legally collecting PII required to minimize redundancies, fraud, improve human subject protection, patient safety, and data variance in clinical trials.

Having a single location for receiving updates and managing the adherence to privacy regulations can be cumbersome, especially for sites using paper-based QMS. The good news is, robust systems offering personalized and digital account services now exist. These systems provide opt-in access for any stakeholder, including physicians, nurses, first responders, clinical researchers, and many others. Universal personal electronic accounts have the potential to revolutionize the dissemination of clinical research personnel information and expand access by providing users with a primary source and single location for parking their credentials and other important PII, as now required by international law.

A robust QMS should also have reminder features and internal protocol/module creation. It is imperative for department administration and research staff to stay aware of the status of professional documentation, records, or CME certification, so they do not become outdated. Innovative developments have allowed researchers to be notified and to individually complete the updating of professional information while managers are more easily able to track such changes.

Sites are now able to comfortably oversee professional documents, set expiration alerts, add third-party verifications, and collaborate with organizations or businesses. Departments such as Human Resources can directly benefit from modern management systems that give them the tools to create site-specific protocols and education modules. Instead of filing and sifting through binders of internal protocols, sites can more easily locate and distribute protocol training for staff readiness by using quick search features. E-learning libraries are also being modernized to include courses pertaining to patient privacy protection, regulatory compliance, and communication standards. Perpetual access to the most recent information is best achieved through the non-siloed, electronic QMS.


Since the COVID-19 pandemic began, business leaders have transitioned their staff to remote work and have seen prolonged success. Efforts have demonstrated that electronic communication and dissemination of process information is possible and can be expanded upon. As emerging technology enhances medical care and clinical research, stakeholders at sponsors, academic medical centers, contract research organizations, hospitals, and independent study sites can prepare executive personnel to integrate even more applications.

Use of telemedicine, artificial intelligence, and digital therapeutic tools are informing medical policies and public health actions. A new approach of setting up robust digital/e-learning libraries as a catalyst for capacity training and education can contribute to shaping the future of research. CME, which includes globally standardized competencies, is key to site feasibility.

It takes time to attain the highest competencies and qualifications for all levels of research professionals. The journey to medical excellence runs through the transferal of lifesaving skills and sound medical decisions to subjects. Countries throughout the globe benefit from incentivized educators and organizations that develop tools which track learning and manage capacity for various personnel. New connective platforms can establish the infrastructure needed for new site opportunities. Education and training can be modified into dozens of languages to provide a standard of care for all patients.

Assessing and implementing the right QMS in combination with high education standards will produce quality practice. Reliance on siloed and outdated systems is holding back site progress. We should not fear change, but rather, learn how new ideas and technology can improve life for all of us.

Al O. Pacino is President at BlueCloud® by HealthCarePoint Professional Collaborative Networks, based in Cedar Park, Texas, and a former member of the Editorial Advisory Board for ACRP.

Matthew Chandler is Manager of Site Engagement at BlueCloud® by HealthCarePoint Professional Collaborative Networks, based in Cedar Park, Texas.