Protocol Optimization

Optimize protocols early, for efficiency and impact

Study start-up has become more challenging in recent years. Protocols are increasingly complex, there’s more third-party data to incorporate, and the industry overall faces additional challenges at investigative sites.

But protocol optimization is a way to cut through the complexity and prepare a truly efficient and effective trial for participants. At Parexel, we engage with you early on protocols to identify challenges and curate site selection strategy to address them. We help you recruit the right patients, minimize patient burden, and work with boots-on-the-ground investigators to align your protocols with patient needs.

The result is a more efficient and impactful study. These efforts are further supported by our clinical adjudication, drug safety and pharmacovigilance, and health economic modeling services.

Clinical adjudication services

When it comes to holistic and successful clinical development, we give you the opportunity to incorporate an adjudication as early as the planning phase, with thoughtful consideration on the specific data that needs to be collected.

Our flexible adjudication program empowers you to pinpoint potential issues earlier in the process. Because this aspect is fully integrated, it gives you more information when making critical study-related decisions, potentially saving time and money.

Drug safety and pharmacovigilance

Sponsors and investigators are responsible for monitoring the balance of risks and benefits faced by trial participants and reporting any change in that balance to regulators. Whether you’re looking to partner for case processing support, aggregate safety reports, literature searching, medical assessment, or for an end-to-end product portfolio maintenance program, our broad and scalable drug safety and pharmacovigilance models will meet your needs.

We handle more than 800,000 cases each year, bringing the flexibility and global reach to support our partners around the globe.

Health economic modeling

As healthcare expenditures continue to rise, payers and regulators are demanding more evidence of a drug’s economic value. This type of analysis used to be reserved for later in a drug’s development, even after launch, but economic modeling is increasingly part of clinical trial design.

Our early stage/target profile model defines the main drivers of cost-effectiveness or budget impact. This model is developed in Phase II or early Phase III and is heavily based on product profile and pricing assumptions to support market access scenario planning. It can assess whether a clinical development program has potential to demonstrate cost-effectiveness, as well as safety and efficacy, and can also determine which parameters require further research to better support the positioning of a drug in early phase development.