Risk-Based Monitoring

Inject Remote Risk Assessment to Optimize Clinical Trial Outcomes

Risk-Based Monitoring


This study explores RBM strategies and their impact on the clinical landscape. This study’s exhaustive metrics include data benchmarks and recommendations from life science industry leaders on establishing an RBM team; planning for RBM-related costs, selecting the right tools and allocating resources; and preparing for and implementing an RBM strategy. Throughout the report, data are broken down by company size and type (top 10, top 50, small pharma and medical device, contract research organizations and academia) and region in which a team operates (US, Europe and Asia).

  • Description
  • Additional information


Preclinical development marks one of the early-stage product development stages. Strategic alignment of early-stage product development teams can ease the burden of successful investigational products’ transition as they move into early clinical stages. More importantly, preclinical operations set the tone for the efficacy of companies’ broader R&D functions.

Early-Stage Product Development: Strengthen R&D Outcomes with Robust Preclinical Structures and Resources

  • Publication Date: October 2014
  • Pages: 339
  • Chapters: 4
  • Metrics: 500+
  • Charts/Graphics: 280+
Report Features

Interviewed CROs and pharma executives caution teams, before they overhaul pre-established clinical structures, to examine how existing staff may contribute to RBM strategies. This report focuses on the structures and staffing roles that companies leverage when conducting risk-based monitoring activities. It also shows how teams that currently lack centralized risk assessment structures may be able to leverage the combined expertise of statisticians, data monitors and drug safety personnel, in conjunction with CRAs, to carry out RBM strategies — rather than add an entirely new function. Read this report to learn how key technology — including electronic data capture (EDC) and clinical trial management systems — improves overall monitoring accuracy and efficiency.

Reason to Buy

This report details the overall value of risk-based monitoring in clinical trials. Data show RBM spending and outsourcing across pharmaceutical and device companies as well as contract research organizations in three regions of operations (US, EU and Asia). Further research highlights companies’ technology and data usage during RBM trials. To maximize clinical opportunities, life science organizations must cultivate thorough RBM strategies. Strategies are often adapted to meet individual trial needs that vary by development phase and product indication. The study examines the usage and types of risk-based monitoring used across specific company types and therapeutic areas. Planning is critical when establishing effective risk-based monitoring strategies. The report’s data examine when sponsor companies and CRO teams begin creating RBM strategies and which factors most impact their decisions. Finally, research highlights key RBM activities that teams must undertake, including site management, source data verification and risk evaluation.

Target Audience

Executives (VPs, directors, managers) of clinical operations, quality assurance, scientific affairs, medical affairs, research and development will benefit from the benchmarks and best practices in this study. Other related roles that will find this study beneficial include:
– Clinical research associates (CRAs)
– Clinical trial staff
– Lead investigators
– Data analysts / biostatisticians
– Drug safety

Related functions include:
– Clinical operations
– Clinical development
– Risk assessment
– Clinical research associates / trial monitors
– Data managers
– Quality assurance
– Pharmacovigilance
– Medical affairs
– Scientific affairs

Chapter Example

Site monitoring schedules are a key consideration for life science companies’ clinical trials. Regardless of clinical development phase or therapeutic area, the level of planned site visitation can potentially expedite or delay trial progress. Traditionally, trial sponsors visit clinical sites every four to eight weeks. In-person site visits help sponsors identify any issues that may arise, including protocol miscommunications and patient safety concerns. Historically, the more often companies conduct site visits, the more likely all clinically facing teams are to be up-to-date on trial challenges and the better positioned sponsors’ clinical staff are to resolve them quickly.

The downside to in-person site monitoring strategies is that this practice may not always be the most efficient in terms of the return it generates. Despite companies’ dedication to performing in-person visits to prevent data errors, Applied Clinical Trials estimates that in-person clinical site visits actually account for less than 3% of the data changes incurred post-monitoring visit. Moreover, this practice can be costly in terms of companies’ limited budgetary and staffing resources. According to a recently published article in Perspectives in Clinical Research, clinical site monitoring accounts for up to 30% of companies’ total clinical trial cost.