The push towards digital solutions like eSource and CTMS continues to grow. Sites are having to use anywhere from 6-11 sponsor systems, or more, per study. Site owners should prioritize adopting digital tools that streamline operations, improve data accuracy, and facilitate collaboration with sponsors and CROs. This helps sites leverage digital automations to stay competitive, while putting the decision of what systems to use in their hands.
Pro Tip: Consider including the cost of a CTMS or other digital management tools during budget negotiations with sponsors.
Sponsors are continuing to face increased pressure from the FDA to meet the diversity enrollment guidance. This means that site owners need to ensure their recruitment strategies target underrepresented populations. This focus will not only improve relationships with sponsors and meet regulatory requirements, but also improve the generalizability of trial results. If your site is not already tracking diversity enrollment data, it's vital to start now.
Pro Tip: If you're able to gather historical diversity data from previous trials, you can use those reports to show sponsors you have a proven record of having a diverse patient population and meeting diversity goals.
Budgeting and payment reconciliation remain major challenges for sites. There are many factors out of the site's control when it comes to payments, but one thing sites can do to ensure they are paid for all the work they do is ensure they are tracking every single billable activity. Site owners can benefit from implementing financial management tools to automate payment tracking and ensure timely reimbursements.
Pro Tip: Leveraging digital automations to ensure you are tracking all costs for all activities will give you a clear financial picture of the true cost of your trials which can improve budget negotiations with sponsors. If you don't track margins, how will you know if a trial is profitable or not?
Investing in staff is crucial as high turnover among CRCs and other key roles can disrupt trials. Continuous training and offering professional development opportunities are essential to retaining skilled personnel and ensuring study quality.
Pro Tip: Understand individual site staff's strengths and career goals. By understanding the unique traits of your site staff, you can foster their growth and build a high-performing team. Supporting and nurturing your staff not only strengthens your team but also creates opportunities for internal promotions, reducing the training burden and empowering experienced employees to mentor others.
Building long-term, mutually beneficial relationships with sponsors is key to securing future studies. Site owners should focus on transparent communication, efficient study execution, and demonstrating their ability to meet sponsor expectations to secure more consistent study opportunities.
Pro Tip: The sponsor-site relationship hinges on open and consistent communication, but constantly compiling and providing updates can burden site staff. Explore developing a streamlined approach to providing sponsors with updates that leverages technology in order to reduce the burden while fostering open communication.