Although it may be surprising to consider, today’s stringent governing oversight of clinical trial activities is, in fact, a relatively recent development. Less than 35 years have passed since 15 United States federal departments, including the Department of Health & Human Services, first agreed to implement The Common Rule. This was a set of regulations created to ensure the safety of human subjects and regulatory compliance by research organizations. As technology and medicine undergo massive shifts, so do the requirements set forth by federal agencies, such as the Food and Drug Administration (FDA). However, contract research organizations (CROs) are developing more digital tools and strategic plans to ensure proper clinical trial compliance is achieved both internally and within their collaboration with biotech or biopharma sponsors.
The Clinical Trial Regulatory Framework
With more innovations rapidly being introduced into the clinical trial industry, a modern regulatory framework must achieve the following tasks to avoid being outpaced.
- Provide study oversight proportional to the level of risk presented
- Allow flexibility for the safe testing of novel therapies
- Promote transparency
- Enable the clinical trial process to be more efficient and streamlined
- Accommodate emerging clinical trial study designs
Read on to learn five key strategies CROs can use to ensure a clinical trial maintains its compliance!
1 | Proactively Embracing Change
The regulatory landscape for clinical trial companies is constantly shifting, and the best CROs will embrace this by putting processes in place to monitor and identify regulation updates globally. Strategies like performing audits to identify existing weaknesses, providing up-to-date employee training, and hiring a dedicated compliance team can help better protect data integrity while enabling early responses to potential risks. Taking the necessary steps to automate regulatory intelligence collection provides research institutions better protection because this information can be molded seamlessly into strategic changes for their current systems to adapt.
2 | Implementing Approved Written Procedures
Written standard operating procedures (SOPs) serve as a foundation for any organization, especially CROs, clinical trial sponsors, and research sites. Often, regulatory infractions will occur as a result of negligence and lack of knowledge. However, developing a balanced set of written SOPs will inform all new team personnel of the standards they are expected to adhere to, as well as better ensure that the highly sensitive activities involved with clinical trial management are performed with uniformity regardless of staff changes. Given the evolving nature of local, federal, and international clinical research standards, SOP content and team performance should be monitored on an ongoing basis to confirm that all overseeing regulations are being followed diligently.
3 | Internal Quality Assurance Oversight
A 2019 case study reviewed numerous warning letters issued by the FDA and the European Medicines Agency (EMA) to propose recommendations for improving regulatory compliance. The researchers found that the majority of regulatory infractions were fairly straightforward but had missed identification by the quality control unit. Accordingly, establishing an independent internal quality assurance team that focuses solely on regular monitoring may allow CROs, sponsors, and sites to enact corrective and preventative actions sooner.
4 | Maintaining Data Integrity & Security
With the advent of the digital era in clinical research, regulatory standards are as applicable to the use of certain technology as they are for the general conduct of human testing. To name a few critical requirements, the right tools will provide advanced permission controls, cloud-based remote access, maintain an audit trail for all electronic activity, use state-of-the-art encryption to protect data privacy, be regularly tested by a third-party IT administrator, and comply with relevant regulations such as FDA 21 CFR Part 11 and ICH GCP.
5 | The Risk-Based Approach
Due to the growing number of clinical research sites within a study, many often dispersed across the globe, risk-based quality management is widely endorsed by both North American and European regulatory agencies. With the use of secure digital platforms which permit centralized monitoring, CROs are able to track information about a product’s safety and risks on an ongoing, real-time basis. This approach proportionally distributes resources and oversight to the most high-risk areas while enabling early identification and response to potentially critical issues.
Modernizing Regulatory Clinical Trial Compliance
Despite the ongoing challenge CROs, sponsors, and sites face in regularly keeping up with the changing clinical trial regulatory landscape, there are reliable strategies that can ensure compliance. Contract research organizations and third-party clinical trial companies can proactively avoid regulatory infractions and any accompanying enforcement fines by continuously monitoring for potential risks, implementing the right digital and operationalized procedures, adopting risk-based quality management, and appointing dedicated quality assurance teams. As a next-generation CRO powered by technology, Vial is delivering innovative products built to the latest regulatory codes to deliver better, faster, and cheaper clinical trial outcomes for sponsors. Connect with a team member today to learn more!
