Improving Subject Recruitment, Quality and Cost with Web-Based CTMS

Slow subject recruitment, poor subject retention and protocol deviations that affect data quality are perpetual problems for anyone managing clinical trials. Delays caused by recruitment or non-evaluable data affect most studies and potentially cost millions of dollars. Sponsors and CROs concerned with achieving their Last Patient In (LPI) targets can make their subject recruitment and retention strategies, planning, and execution far more effective through the use of an integrated web-based CTMS. Through appropriate use of technology platforms that bring together disparate information from across the organization, Sponsors and CROs can better predict and manage recruitment, retention, and data trends through web-based technologies.

A web-based Clinical Trial Management System (CTMS) helps improve recruitment efficiency by providing the tools to leverage existing subject databases, effectively track study start-up tasks in parallel, evaluate trends in subject data and implement and integrate a web-based virtual recruitment strategy. It enables the organization to centralize crucial information for subjects, sites, countries, and studies to ensure an accurate and efficient workflow throughout the clinical trial process while continuing to assess areas that may require additional focus or training during the course of the study.

Access to real-time data allows trial Sponsors to more accurately address three vital questions about subject recruitment:

• What are the likely enrollment rates for a particular clinical trial?
   
• How will known development issues (such as staggered study startup, holiday periods, and challenging study entry criteria) impact my LPI milestones?
   
• Who are the best investigators to achieve the required recruiting objectives?

Information concerning the feasibility or difficulty of subject recruitment for specific types of subjects, indications, and sites directly impacts the accuracy of projected enrollment rates. By identifying appropriate data assets to support feasibility studies and site selection, sponsors can make the right decisions about trial staffing, budget, and timelines and positively impact subject recruitment. A web-based CTMS can help sponsors and CROs improve productivity by centralizing information and providing real-time access from multiple locations. This makes scheduling, study status, staffing, and financial management more efficient.

Adapting a web-based CTMS allows Sponsors and CROs to minimize the execution of contingency plans and tracking tools implemented only after subject recruitment issues develop. By building proactive contingency plans with predefined triggers available through web-based CTMS, months of delay and costs can be saved by detecting signs of trouble well before they become major issues.

A web-based CTMS improves budget management, utilizing real-time data to get an accurate snapshot of the profitability of a study. Single-site and multi-site clinical research organizations, and those converting from manual spreadsheets and other ad-hoc paper-based systems, can expect to see significant gains in enrollment efficiency through the adaptation of a web-based CTMS to help meet their enrollment requirement needs in an efficient and timely manner.

Utilizing a web-based CTMS can also enable Sponsors to more accurately predict, monitor, and manage subject recruitment and data quality while avoiding expensive and risky trial delays. Financial planning around investigator agreements can be better managed and sites share their positive experiences for successful study implementation. All of these items can be leveraged to reduce costs and bring new products to market faster, improvements which are critical to success in today's highly competitive life science marketplace.