By Gage Drake
Oncology trials by Veristat differ from other types of clinical trials in that they are more complex, including biomarkers, and use adaptive oncology trial design. For this reason, they require CROs with the experience and know-how to handle the increasing complexity of these trials. A contract research organization (CRO) is a company that oversees clinical trials for the pharmaceutical, biotech, and medical device industries.
CROs offer a variety of services, including site selection and activation, recruitment support, clinical monitoring, data administration, trial logistics, biostatistics, medical writing, oncology clinical trial design, and project management. CROs are primarily responsible for the organization, coordination, execution, and management of the processes that go into starting a clinical trial. They also serve as a point of contact for the sponsor and other trial participants such as regulatory agencies. They also help you to:
Explore Different Adaptive Designs
To significantly diminish the effects of the placebo effect in trials, consider using adaptive oncology clinical trial designs like the sequential parallel comparison design (SPCD). Exploring a model-based drug development method provides a basis for your trial design, dose selection, and study execution decisions which boosts clinical development efficiency. Some CROs have already established in-house quantitative clinical development divisions to analyze the relationship between medications, diseases, and patients using statistical models. Pursuing new designs will eventually assist your development teams in capturing the necessary data for regulatory approval.
To Help in the Management of Big Data
A CRO will help you in the implementation of next-generation cloud-based clinical trial management solutions. This will ensure accurate data integration from a variety of internal and external sources, as well as on-demand, real-time access to critical information. These solutions provide web-based, device-independent tools enabling sponsors to easily extract essential trial data from enormous data sets and make quick, informed decisions to reduce costs and time. These tools can be used for data review and analytics during a trial and to ensure you get the best results, they must be implemented properly. As a result, you’ll be able to better manage the trial lifecycle, leading to enhanced operational efficiency and process optimization. Implementing tools like eClinical solutions can also result in increased collaboration across the value chain, enhanced regulatory compliance, and cost-effective, real-time data management.
For Risk Monitoring and Mitigation
To increase patient safety and data quality, a CRO can help in the adoption of risk-based monitoring (RBM) strategies to proactively identify and define research risks, as well as adopt appropriate mitigation measures. To follow specific data sets for source document verification, for example, you could use remote data capturing technology and clinical trial monitoring systems (SDV). RBM can also be useful for focused monitoring to reduce the need for SDV. When compared to traditional monitoring strategies, RBM allows you to achieve greater trial efficiencies in terms of cost reductions and resource allocation. Considering that on-site monitoring contributes 25 percent to 30 percent of the overall cost of clinical trials, this might become a resource that gives you a competitive advantage.
CROs are vital in the success of oncology trials. That said, a careful examination should be done on a project’s requirements, budget, and specifications before selecting the preferred CRO.
