The Association of Clinical Research Organizations (ACRO) provides several resources to help improve the quality and compliance of clinical trials and studies. These include surveys that assess plans, hospitals, medical groups, and educational programs for clinical trials and research professionals. ACRO also inspects to ensure sponsors, sponsor-investigators, and nonclinical studies comply with FDA regulations.
Surveys assess plans, hospitals, and medical groups
If you are an organization working to improve quality and compliance, you may benefit from Joint Commission accreditation. Accreditation provides credibility for healthcare organizations and gives them a competitive edge in the marketplace. It also enables staff development and enhances staff recruitment. The healthcare system is changing in many ways. Increasingly, patients are receiving care in nonhospital settings. Moreover, employers are reducing their benefits and focusing on cost-reduction strategies. This shift in policy is driving providers to find new ways to provide excellent care while containing costs. In addition, the aging population continues to increase the percentage of Medicare and Medicaid patients. As these healthcare providers seek to address this growing challenge, the HHS Partnership for Patients initiative aims to lower readmissions, preventable complications, and the number of hospital admissions. These efforts involve a public-private collaboration that includes hospitals, quality improvement clinical research organization companies, and hospital engagement networks. A critical component of improving safety and quality is ensuring that clinicians are adequately trained. To this end, the Agency for Healthcare Research and Quality (AHRQ) develops training materials and tools for clinicians and other healthcare providers.
There are many ways that sponsors can improve the quality and compliance of their clinical research. In addition to developing internal procedures, some sponsors have established quality assurance units to perform independent audits. These units evaluate the processes, systems, and data handling methods the sponsor uses. The FDA has been working to develop new guidance to assist sponsors in improving the quality and compliance of their clinical investigations. It has created opportunities for stakeholders within the FDA and outside the agency to provide input. For example, sponsors can review the FDA’s Clinical Programs Manual, which includes guidance on gathering evidence and developing recommendations. The FDA’s bioresearch monitoring program visits clinical sites, nonclinical animal laboratories, IRBs, and other research facilities to ensure the safety of human subjects. During these visits, the quality assurance unit reviews the processes and procedures for collecting, storing, and reporting data and conducting quality control reviews. The FDA’s Center for Drug Evaluation and Research maintains a list of clinical investigators, including their addresses. This list is updated regularly. The list includes information on inspections conducted since October 1, 2008.
EHR system provides decision support for clinicians
Electronic Health Record (EHR) systems are designed to automate the collecting, organizing, and retrieving patient health information. This allows clinicians to make better decisions based on accurate data. Using EHRs can also increase the quality of care. In addition to improving the quality of care, an EHR can lower costs. For example, physicians can reduce the duplication of tests and minimize errors. Also, EHRs are an effective way to build and maintain relationships with patients. One of the latest features of comprehensive EHRs is embedded clinical decision support. CDS systems provide expert systems to assist with medication dosing, medication interaction, and workflow management. They also serve as evidence-based decision-support tools. While the benefits of EHRs are undeniable, choosing the right system can be tricky. The most common complaint is the cost of implementing an EHR. However, with some planning, the financial burden can be avoided. The government has set up a $27 billion incentive program to encourage the adoption of electronic health records. Physicians and other healthcare providers can qualify for incentives if they meet specific requirements. To be eligible, they must use certified vendors and show meaningful use of an EHR system.
Outsourced services played a significant role in the clinical trial
Outsourced services have played an increasingly important role in the clinical trial industry. These include outsourcing clinical data management, site management for trials, and human resources. Despite their importance, there are many advantages and challenges to outsourcing. Regardless of the type of outsourcing, the process of conducting a clinical trial involves some ethical issues. The safety and well-being of participants must be assessed appropriately. For a successful clinical research partnership, there needs to be a strong working relationship. This includes clear communication and mutually agreed-upon goals. A decision-making group must agree on the scope of services and the timing of key deliverables. Among the most important considerations is the level of technology required to support the research. Technology is essential for medical monitoring, data collection, statistical analysis, and reporting. With it, efficiency and quality may improve. Historically, many pharma companies have relied on services from CROs. They can help a company overcome a wide range of clinical development challenges. As the number of upcoming clinical studies increases, there is a need for more outsourcing. In addition to the cost savings, smaller biopharmaceutical companies can access a broader range of services.