Why is a Study Start-up Management System the vital tool sponsors need?

By: Sarah Hof

Countless industries are shifting to virtual and remote operations, and the realm of clinical trials is no exception. In fact, COVID-19 has only accelerated our industry’s dependence on technology to efficiently and successfully run trials. This shift has prompted the field to accept virtual or decentralized clinical trials as a trusted means to conduct research of such vital importance.

As teams become empowered to work from anywhere in the world, it is necessary for all stakeholders in a trial to have readily-available access to information on the clinical trial in real-time. The proper tools and technology to navigate a decentralized clinical trial ensures a successful outcome for the sponsor, and more importantly, an accelerated timeline for patients to gain access to life-changing medicines.

What is a Study Start-up Management System?

A Study Start-up Management System (SSMS) is an essential tool to efficiently accelerate clinical trial start-up. From all steps throughout the start-up process beginning with targeting the right sites, assessing site interest, conducting feasibility, collecting essential regulatory documents, obtaining approvals and contracts, and finally, enrolling patients, an SSMS ensures that a trial launches on-time and with the optimal sites.

There are three hallmark features of an SSMS:

  1. A built-in database of investigators. To deliver the optimal sites, every SSMS includes a built-in database of investigators.
  2. An automated workflow. By design, the system’s automated workflow enables a sponsor to quickly move from task to task and ensure that the start-up is progressing with no hold-ups.
  3. A cloud-based structure. The cloud-based nature of the system provides readily available access to data, metrics, and reporting anytime and anywhere.

Differing from other trial management software, an SSMS assists in the launch of a trial, while others such as a CTMS manage separate aspects of a trial after it has been launched and patients are being enrolled.

How can an SSMS help sponsors?

It is well-known that the most common source of delays to a trial is patient recruitment. This stems back to sponsors selecting initial sites that either prove unreliable once patients have been enrolled, or fail to enroll patients at all. In fact, according to the Tufts Center for the Study of Drug Development, 37 percent of sites selected under-enroll, and 11 percent fail to enroll a single patient. These routinely poor start-up metrics can lead to delayed trial timelines, and a 20 percent or higher increase in the originally projected trial budget.

When a sponsor selects the optimal sites first, patient recruitment is realized, the trial can proceed on-time, and the sponsor gains approval of vital medicines for patients in need. This efficient sequence of the events is possible using a Study Start-up Management System, with the built-in database of ranked investigators and an automated workflow to effectively launch the trial.

How does AcceleTrialdrive clinical trials forward?

AcceleTrial™ was created with the founding principle that nearly all clinical trials can avoid delays by selecting the right sites initially. Not only does AcceleTrial™ have a database of over 100,000 global expert investigators, those investigators are all ranked objectively. Its proprietary algorithm pulls hundreds of data points from multiple sources based on clinical expertise, access to patients, and former clinical trial experience, among other metrics. This powerful ranking system ensures that ultimately, the most effective and optimal investigators and sites are selected for the trial, thereby mitigating any chance of delay.

The “push and pull” workflow ensures a steady momentum, tracking each step and keeping the process seamless. To add transparency, both the sponsor and the sites and investigators are able to access the platform and complete their respective tasks while monitoring the full scope of the process. AcceleTrial™ is designed to be intuitive and make a significant and immediate impact on a trial’s launch time and operational costs.

When a trial progresses smoothly, the greatest value is the potential to make available life-changing medicines for patients who need them most.