We recently came across two good articles that study the rising costs of clinical trials across all phases:
We found that many of the issues outlined in these articles resonate with our focus to streamline clinical study management through an effective CTMS solution. Here are a few ways SimpleCTMS is currently helping our customers.
A focused, effective study management and monitoring team
Study managers, country managers and CTAs avoid redundant and repetitive manual data entry tasks and need not spend their hours reconciling spreadsheets or searching for the latest status of CRA visit reports. CRAs are on the front lines and have a lot of relevant and timely information to share. SimpleCTMS provides a collaborative, integrated, secure environment to plan and track all aspects of the study life-cycle. For example, by using the integrated calendar for CRA site visit scheduling, the completion status of each CRA site visit report is immediately visible. This provides managers with timely insight and transparency into the CRA-site resourcing model while country and study managers remain current with the latest site trends noted by the field team. Through the use of the Data Planning area within SimpleCTMS, sites with excessive subject data to be completed or monitored are easily identified and corrective actions facilitated. For example, additional site and CRA resources can be identified to assist or additional enrollment at overextended sites can be temporarily held pending a quality review of the overdue data. In the big picture, these items are all critical and telling components of good quality data at the end of the study.
Make critical decisions sooner, with more accurate data.
With both internal and external study team members collaborating within the same system, comprehensive, up-to-date information is available at your fingertips. The SimpleCTMS dashboards and reports roll up key study metrics to show trends and problem areas of the study or program. A quick glance at the SimpleCTMS Recruitment Graph can show actual recruitment progress falling below target and high enrolling sites or regions to keep your eye on. As more and more “best in class” solutions are adopted, vendors are seeing firsthand that sponsors expect good quality data outcomes. Data must be squeaky clean when it is completed and CRA queries need to be detailed and driven toward the primary and secondary endpoints. Non-evaluable data must be identified early and mitigated quickly across all sites. All team members must be sufficiently experienced to identify and question small issues before they become barriers to study success. Managers must be able to quickly identify the difference in a slow study start at a site due to additional training needs and a hurried start at another site with extensive protocol deviations. Training and retraining must be conducted based on trends noted and with careful consideration of regional nuances and protocol interpretations.
SimpleCTMS can be utilized to facilitate all of these needs. Protocol deviations can be tracked consistently across subjects, sites, countries and regions. Immediate trending capabilities provide study team members with valuable insight into site, vendor and systemic data trends and enable corrective measures to be taken. Study, country and site milestones and timelines are immediately visible to enable detailed oversight by respective
team members. Information integrated with EDC and IWRS provide relevant trending of targets versus actuals for careful oversight. Saving time by delivering real time study management solutions ultimately saves the organization money and speeds the time to regulatory review and commercialization.
As outsourcing increases, maintain control of study planning and tracking
As the lead study management team, both sponsors and CROs benefit from ownership over the study management data. Avoid “out-of-scopes“ by having your planning and tracking process laid out from study start, via a sleek and intuitive web-based CTMS. With SimpleCTMS, vendors can manage performance in their region and recommend adding or bypassing on countries or sites that are delayed in receiving necessary regulatory approvals. Supply chain activities can be accurately managed to assess the most efficient and inexpensive mechanism to provide necessary items to all participating sites. Critical tasks and planning activities are easily and consistently defined across vendors using standard picklists and date formats. This allows internal and outsourced teams to track and trend information in the same manner for their individual and upper management needs. Critical alerts and action items can be managed with ease. Document workflows and information sharing can be consistency processed around the globe with easy-to-use and secure document repositories. With filtering, sorting, grouping and other features built-in to SimpleCTMS, sponsor and vendor teams can display data the way they want to see it and focus on the task at hand. With SimpleCTMS, study startup planning is optimized and made easy!
Leveraging cost effective technology
With technology expanding, it seems silly to us that rising technology costs cannot be kept in check. We are all presented with more choices and different devices; however, the underlying goal of life sciences companies remains the same – to get to market quickest. By its inherent design, SimpleCTMS is built to be a collaborative, helpful solution that integrates well with other applications while minimizing duplicate entry across data sources. In our opinion, utilizing technology for information sharing should take less time and energy, not more. Trolling through extensive and excessive emails of content not relevant to you is expensive so why not try something that is easy to adopt, easy to use, and fiscally responsible?
Analytics to help you select the most effective sites
SimpleCTMS maintains a wealth of information and data points about the sites and investigators that participate in your studies. Cross-study key performance indicators (KPI’s) and visualizations can help you select the investigators that perform best for your studies. For example, compare historic enrollment performance (target screens and randomizations vs. actual), average duration of activation activities, data completion metrics and cumulative protocol deviations/exceptions.
With our Software-as-a-Service (aka. SaaS, web-hosted) model, SimpleCTMS offers flexible monthly subscriptions on a per user basis. Pay only for the user accounts you need, with no term commitment. eClinical integration is also fast and cost-effective with our flexible technology platform, so the CTMS can be automatically populated and updated with the latest study management data from your EDC and IWRS system. And there’s no startup hardware cost to absorb.
We’re always happy to chat about your study management challenges, and how SimpleCTMS can help streamline your study planning and tracking. Please contact us or request a demo to get the conversation started.