An integrated approach to clinical and laboratory operations can help drive trial efficiency


The segregation of central lab and clinical research services, as is typical in traditional models, promotes barriers to operational efficiency and can generate unnecessary problems and delays. For example, at the end of many trials a flurry of reconciliation requests are made of site staff to clarify potential errors regarding sample labeling. Delayed reconciliation can lead to a higher rate of forfeited samples, delays to database lock, and frustrated investigators.

 These problems can be significantly ameliorated by integrating central lab and clinical operations. Such a project delivery framework - which includes combined databases and joint planning between laboratory and clinical project management - ensures that all aspects of clinical risk are addressed. Additionally, a shared database consolidates and standardizes data for scientific, safety, and quality assurance purposes.


Benefits of Integrating Clinical and Laboratory Services

Optimised project and risk management: Cross-training project managers to work together from a single integrated study and risk management plan is the basis of an integrated project delivery framework.

 An important feature of this integrated framework is joint laboratory/clinical error management planning, which ensures that all aspects of clinical risk are addressed, leading to increased site compliance and data quality. This includes risk assessment of key lab parameters that can affect critical study endpoints, outcomes, and the cost of trial execution, so as to identify issues such as unrealistic testing windows before a change order or protocol amendment may generate unnecessary costs.

Improved site and investigator experience: Managing a trial can present logistical challenges including organising, managing, updating and deploying documentation. Coordinating training and monitoring, and combining databases, can reduce reconciliation requests and alleviate burden on site staff. Specific software such as ICON’s FIRECREST training program can improve communication, workflow, and compliance at investigator sites while also supporting patient recruitment and retention.

Additionally, creating a unified support structure that involves the lab site and the clinical research associate can strengthen the relationship between the contract research organization and site, and can improve overall data quality.

Integrated data and query management: Over the course of a long trial using standard data management models, discrepancies between clinical and lab data accumulate in the database. This can require a lengthy reconciliation process that can delay database lock. An integrated clinical and lab database can prevent this by using a continuous data-cleaning process that identifies data discrepancies early, such as violations of inclusion or exclusion criteria, unreported adverse events, fraudulent data, and incomplete reported data. Not only can these issues be addressed earlier, but prompt resolution of issues increases site compliance and data quality for the remainder of the trial. In the end, the cost savings to sponsors can be as much as 50% for larger trials.

Partnering with an organization experienced in integrating clinical research and central laboratory services, such as ICON, will help to remove risk in trials and saves costs.

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