According to Veeva Unified Clinical Survey Report, healthcare organizations using Clinical Trial Management Solutions have 58% better compliance. The report has also predicted improved governance and greater visibility for CTMS users. These solutions are dedicated to managing clinical operations involving administrative roles, analyzing statistics, and field-based monitoring. Most patient recruitment services use these clinical operations to ensure a smooth clinical trial process. Comprehending every clinical function is quite daunting, read along to get a complete overview of clinical operations and their importance.
What are Clinical Operations?
The activities that assist the clinical trial process like research and surveys, from beginning to end are called clinical operations. These operations play an integral role in ensuring that the patients are getting high-end treatment or medication. Clinical operation managers are responsible for every phase of the trial process from planning, and management to implementation and integration. Moreover, they have to check if the procedure complies with the latest regulations and SOPs.
How do Clinical Operations Teams Work?
The clinical operations team has many responsibilities that require complete attention or it could impact the entire result. The team handles every task including ideation, planning, and executing all four phases of clinical trials.
The clinical operations team can vary in size or expertise depending on the intensity of the clinical trial. It can range from regional teams of 3-4 people to international committees from different parts of the world. The teams include:
Administrators for managing daily trial activities.
Research Associates who commute to different research units to make sure that the trial process is streamlined.
Project Managers for dealing with the teams and trial highlights.
Directors who are completely in charge of the trial.
The clinical operation teams also interact with other departments such as biostatistics, clinical sciences, and regulatory affairs. They ensure the accuracy of the data delivered to these departments for a transparent evaluation of the trial.
Why are Clinical Operations Important?
Clinical operations are crucial for delivering efficient, high-quality healthcare services. They optimize patient care, resource utilization, quality assurance, regulatory compliance, and data-driven decision-making. These operations are of utmost importance in the healthcare industry for several reasons:
Efficient Patient Care
Clinical operations ensure that patient care is delivered smoothly and efficiently. They involve processes such as patient intake, scheduling, and coordination of healthcare providers, ensuring that patients receive timely and appropriate care. Well-managed clinical operations minimize wait times, improve communication between healthcare professionals and patients, and enhance the overall patient experience.
Effective clinical operations help in optimizing the use of resources, including medical equipment, facilities, and staff. By properly allocating resources and managing workflows, healthcare organizations can minimize waste, control costs, and maximize the utilization of available resources. This leads to improved efficiency and financial sustainability.
Clinical operations play a crucial role in maintaining and improving the quality of healthcare services. They involve implementing quality assurance measures, adhering to best practices and standards, and monitoring outcomes to ensure that patients receive safe and effective care. By focusing on quality, clinical operations contribute to patient safety and positive health outcomes.
Healthcare organizations are subject to various regulations and standards imposed by regulatory bodies. Clinical operations help ensure compliance with these requirements by implementing appropriate processes, documentation, and protocols. By adhering to regulatory guidelines, clinical operations help safeguard patient rights, privacy, and overall safety.
Data-Driven Decision Making
Clinical operations increasingly rely on data analytics and technology to inform decision-making. By collecting, analyzing, and utilizing data, healthcare organizations can identify trends, evaluate performance, and make informed decisions to improve operational efficiency and patient outcomes. Data-driven insights enable evidence-based practices and continuous improvement in clinical operations.
Adaptability to Change
The healthcare industry is dynamic, with advancements in technology, evolving patient needs, and changing regulatory landscapes. Clinical operations must be adaptable to these changes, embracing innovation and incorporating new technologies and practices. This adaptability ensures that healthcare organizations can effectively respond to emerging challenges and opportunities.
Responsibilities in Clinical Operations
There is a wide range of activities that are covered under the umbrella of clinical operations, including:
Patient Journey Funnel
It is to determine the steps completed by patients based on the entire process during the clinical trial.
It makes sure that staff and practitioners are following safety procedures and obeying the protocols to avoid any harm.
Clinical Quality Assurance
It tracks the quality of care the patient receives as per the regulatory agencies’ criteria. Different quality assurance methods are utilized for 100% satisfaction like chart audits, feedback programs, etc.
Updated with Trends
Operation teams also have to keep tabs on the latest trends in the healthcare industry. They even have to think of the impact that these trends can create on clinical trial processes in the future.
Main Challenges Faced by Clinical Operation Managers
As we have mentioned before managing clinical operations is quite challenging, following are the hurdles faced by the clin-ops managers:
Patient Retention & Recruitment
The most significant issue that clinical operations experts are facing is patient recruitment and retention. The delegates noted that patient engagement and access to clinical trials are very important for innovation in the healthcare industry. However, raising awareness for clinical trials and encouraging patients to enroll takes a lot of effort and convincing struggle.
Another significant industry challenge identified was clinical outsourcing, particularly creating an outsourcing model. Moreover, finding partners having similar visions and goals for the industry is viewed as the main issue for running major pharmaceutical businesses.
Data Confidentiality & Storage
Most clinical operation managers stated that data mining, collecting, maintenance, and analysis techniques are needed improvement. Also, patient data confidentiality is an essential issue since it requires advanced security that is up to par with the latest standards and needs frequent updates.
Resource & Expense
Costs and resource issues stand as another major issue for many clinical operation managers. They talked about the struggle of managing labor costs, internal resource allocation, and clinical study cost reduction. Issues concerning the site are also a highlighted challenge. In particular, there were issues with activation, site capacity building, selecting important sites for clinical trials, and connecting with clinically authorized labs
Another problem that many of the operations managers reported was risk management. Mitigating risks was termed to be important at the research and study level. Moreover, the usage of database locks and maintaining data quality through consistent monitoring is important to tackle future challenges in central risk monitoring.
It gets difficult for clinical operation managers to be ready for every type of inspection at all types. The only solution on this matter is to equip all the latest resources in the almost impossible market.
In conclusion, clinical operations are vital for the efficient and effective delivery of healthcare services. They involve various activities, technologies, and collaborations that aim to streamline processes, optimize resource utilization, and enhance patient outcomes. Effective targeted patient recruitment services require strong leadership, collaboration, and effective communication among healthcare professionals. Clinical leaders play a pivotal role in overseeing operations, implementing best practices, and driving continuous improvement. Collaboration among different departments and stakeholders is essential to ensure coordinated care and optimal outcomes for patients.