Our Approach

We Measure What Matters

Consistently evaluating critical outcome measures is the key objective in ensuring effective and meaninful clinical trials. The CAP program accomplishes this objective with three distinct but complementary services. First, CAP's experts participate in protocol design aimed at optimizing both primary and secondary endpoints and the mechanisms to collect them. Second, CAP provides protocol and indication-specific training of assessors and study team members using a variety of methods including in-person, on-site training performed by CAP-certified site educators, customized educational materials such as handbooks an tip cards, and other tools such as websites and digital video. Third, CAP utilizes its unique data quality management program that provides continous review and analysis of endpoint data to ensure assessor accuracy and consistency. Errors and other data anomalies identified by CAP's analysis resullt in prompt action to resolve issues before they become systemic. Using blinded data modeling and analysis, outcomes are mapped and tracked to provide study data trends.

CAP's program has markedly reduced investigator and assessor errors, greatly improved data accuracy and shortened the time to data lock. In addition, the program has been well received by the FDA and other regulatory agencies.

Understand the Medical Condition and Customize the Program to the Endpoints
We begin with a careful review of the study design and outcomes, with a strong focus on working to develop a protocol that is practical and complete. The process includes developing a thorough understanding of your drug’s mechanism of action in which we peruse preclinical data and prior studies as necessary.

Unparalleled Training and Education
Armed with a solid understanding of the study design and desired outcome measures, we create numerous protocol and indication-specific tools such as video DVDs, tip cards, customized presentations and handbooks, and CAP’s renowned source data worksheets. Some of these tools are used to educate clinical research personnel as to the indication, the drug, and its importance. Other tools are used at the site to focus attention on assessing subjects and collecting data in a consistent and uniform way. There are no shortcuts to CAP’s training and education services, and the results speak for themselves.

Real Time Study Management and Performance Tracking
CAP is a pioneer of real time study management techniques. Our proprietary method of data review and site quality analysis provides up to the minute measures of study recruitment, data quality and investigator accuracy to put you in control of your study like never before. Now, you don’t have to wait weeks or months for accurate feedback from your sites as to the status of critical studies – you can find out immediately – without gimmicks like special software or reliance on web-based products.

CAP Program Goals and Objectives

While specific goals and objectives may vary from client to client and from project to project, the following four program goals and objectives constantly guide the CAP team.

1. Facilitate healthy interaction among sites, vendors, and the sponsor by providing an organized, responsive and accountable clinical management team;

2. Standardize and ensure consistency of study endpoint assessments for all investigative sites;

3. Maximize assessor accuracy and compliance by closely tracking critical endpoint data while patients are still on study, and;

4. Shorten the time to database lock following study completion by reducing the number of clinical data clarification requests.

we measure what matters