WHITEPAPER Achieving Clinical Operations Excellence

The Challenge with Clinical Operations

Running effective clinical trials is difficult at best. Information on trial progression (i.e., enrollment, budget and milestones) is typically not readily available and easily accessible to study management teams. With almost 80% of clinical trials failing to meet enrollment timelines,1 proper oversight of clinical development operations is imperative. With significant trial delays experienced across many programs, managers of clinical trials struggle with visibility into trial progression and site statuses around the globe. Issues within the trials can be difficult to detect even with highly qualified CRAs and Project Managers on staff. Traditional reporting methods can be slow, cumbersome and too time consuming to use, and as a result, clinical portfolios can be mismanaged, or not managed at all, costing companies valuable time and resources, and in the worst case, compliance issues.

Author

Ben McGraw

Strategic Marketing

PerkinElmer, Inc.

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Figure 1. Global Progress within Trials across Clinical Development Portfolio.

The Solution

Companies that have deployed interactive data visualization and analysis solutions developed by PerkinElmer throughout clinical operations organizations have helped move these groups toward clinical operations excellence. PerkinElmer solutions for clinical operations provide timely information and actionable insight that enables optimal study startup, budget and milestone tracking. The solutions for clinical operations are relied upon by program managers, country managers, study managers and monitors to make decisions based on live, interactive scorecards. PerkinElmer’s easily rendered visualizations enable the rapid determination of the current state of a program, trial or site status, which helps gain insight into areas of potential issues, allow the understanding of the source cause of issues, and improve the management of clinical performance through metrics and KPIs.

By allowing the visualization and analysis of all levels of the clinical portfolio hierarchy, power is given to end users to perform their roles more accurately and

effectively. By reviewing and analyzing the operational or peripheral trial data, insights are gained which lead to improved site performance and optimize study resources. Addressing site and resource poor performance result in the increase in data collection speed and patient recruitment pace, enabling shortened or on-time study timelines.

Clinical operations is empowered to make better decisions on timing of trial monitor visits based on enrollment and visit schedules, allowing for a reduction in travel budget and other related expenses. Site time to data entry can be reduced and protocol violations can be found much earlier, saving companies significant money by detecting them sooner. Clinical trial data can be accessible to trial monitors so they can assess issues such as overall data quality and focus efforts on poor performers. Using this analytic approach, companies are able to easily identify and retain investigators who have a high degree of success meeting enrollment and performance targets.

Figure 2. Recruitment of Patients for Study.

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Study Startup

Entire clinical portfolios can be mapped out on a timeline showing projected trial enrollment. Sites that lagged in enrollment or had issues with site withdrawal are easily seen then explored at the regional level to improve site enrollment by region. The company is able to identify investigators who meet enrollment milestones and have the right subject demographics. They are also able to determine if the subjects enrolled do not meet the enrollment criteria. This in turn helps the company

determine if the sites were high or low enrolling, which has many downstream effects such as clinical supply planning and site inclusion or exclusion in a trial.

Milestone Tracking

Companies can see how trials are progressing compared to plan for key milestones such as Investigator Review Board approvals, last patient visit, and study close at the study, country and site level.

Figure 3. Trial Enrollment across Clinical Development Portfolio.

Figure 4. Milestone Performance.

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Figure 5. Drop rate vs. screening failure rate for each site across all trials.

Benefits Observed By Roles

Able to efficiently manage their portfolio

via the use of live, interactive scorecards

based on key performance indicators which allows for the

analysis of regional and study trends.

Keep a good handle on regional performance,

perform regional comparisons, and

analyze site performance metrics.

Identify trends and outliers, perform budget

management and analyze country and site performance. Monitoring

report data can be viewed.

Prioritize work via data driven monitoring which enables

the identification of protocol violations, patient retention, etc.

A dashboard view allows for the prioritization of monitoring

reports that need to be completed. CRAs can easily identify sites with the lowest performance; study sites with

new data since they last visited or sites never visited; and low

number of screening vs. enrolled. They also monitor

report completion time.

Program Managers Study Managers Clinical Monitors / CRAsCountry Managers

Budget Tracking

Planned versus actual budgets can be tracked at the study, country and site level showing the cumulative budget versus the actual budget as well as a drill down to each payment made to each site.

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Results

Clinical operations professionals typically spend vast amounts of time compiling spreadsheets and manipulating data to create charts and graphs or rely on inflexible BI tools. Incorrect data and new queries create further delays. PerkinElmer solutions for clinical operations equip clinical operations organizations with the ability to effectively analyze key data, without the time lag and inaccuracy associated with standard reporting processes. PerkinElmer solutions for clinical operations can:

• Decrease monitoring visits and related expenses via data-driven monitoring utilizing site dashboards with KPIs such as recruitment pace, withdrawal/failure rates, missing data, bad data, etc.

• Decrease patient visit to data entry time

• Save money per problem patient via proper site management

• Reduce protocol violations

• In seconds, visualize trip report data versus sorting through thousands of records per study to find those of interest

• Rapidly identify poor enrolling sites allowing for study timelines to stay on track

• Visually leverage historical Site KPIs to make decisions on new site recruitment, providing the optimized scenario for successful trial progression

PerkinElmer has given clinical operations organizations the unprecedented ability to reduce the time, cost and risk of running clinical trials while accelerating the time to market for products across the entire portfolio of clinical candidates.

References

1. Clinical trial delays: America’s patient recruitment dilemma. July 19, 2014. Accessible at: http://www.drugdevelopment-technology.com/features/featureclinical-trial-patient-recruitment/

It is the responsibility of the end user to install and validate PerkinElmer solutions within the end users quality systems in accordance with their policies and standard operating procedures.