Producing consistent, valid clinical trial results on schedule requires proactive planning to reduce risks and maintain quality. At the same time, pharmaceutical, biotechnology and medical device companies are looking for cutting-edge technology, expertise and processes to constantly optimize performance and find new efficiencies. Given these complex demands, how do clinical trial sponsors ensure they’re conducting successful trials?
- Clinical trial management and support
“The most important tool for ensuring human subject protection and high-quality data is a well-designed and articulated protocol,” notes a Food & Drug Administration (FDA) guide. Setting up a clinical trial for success begins with a protocol that has a clear objective and purpose, which will anticipate potential needs, manage risks and create a smooth and transparent process going forward.
“Transparency is a common goal for clinical trial sponsors,” notes Stefanie Newkirk, an EASi Science project manager with 18 years of experience in the pharmaceutical industry. “They want to know they can always rely on consistency in quality, communication and resources.”
This includes minimizing any retention issues behind the scenes, she says. “A services provider can’t deliver if the team is always changing. The process needs to be managed carefully in terms of allocating resources, assessing bandwidth and making sure the team is engaged and productive.”
In recent years, developments in technology and process optimization have helped streamline the process of critical trials, but it’s still critical to minimize avoidable disruptions. Having one central point of contact and a comprehensive retention strategy helps monitoring teams ensure clinical trials are conducted with full regulatory and process compliance from start to finish.
Past methods of monitoring followed a one-size-fits-all approach that applied a high volume of resources through the lifecycle of each study despite fluctuating needs and return on investment. More recently, best practices dictate a more agile, adaptive process that takes advantage of advancements in digital systems, records and statistical data assessment.
Risk-based monitoring fosters an environment of continuous improvement by focusing the greatest monitoring effort on the evolving areas of greatest need, which have the most potential to impact subject safety and data quality. It has presented opportunities for approaches such as centralized monitoring that can improve the quality and efficiency of sponsor oversight of clinical investigations.
Concurrently, pharmaceutical, biotechnology and medical device companies began streamlining processes and casting a sharp eye on cost containment. In recent years, the “shrinking labor force” has also spurred companies to make strategic decisions on how and when to deploy human capital resources.
“Target- or risk-based monitoring is a significant change in the industry norm,” says Newkirk. “With access to real-time data and reporting, it’s less important for a data monitor to be on-site, which has an impact on costs.” The data monitor can collect the data, run queries, scrub and organize the data with no loss of accuracy.
- Data management
Clinical trials rely on the quality of their data, ensured by procedures that are assessed for quality at regular intervals during a trial:
- Design and annotating Case Report Forms (CRF)
- Design database design
- Data entry
- Data validation
- Discrepancy management
- Medical coding
- Data extraction
- Database locking
Project and trial managers also follow Good Clinical Practices (GCPs) and the sponsor’s Standard Operating Procedures (SOPs) are followed at all times.
Clinical trials are a complicated and high-stakes undertaking. But by establishing protocols, on-site or remote monitoring and careful data management, they can produce significant advances in developing new drugs, treatments and medical devices.
Want to learn more about setting up clinical trials for success? Contact EASi now.