Services > Accelerated Trial Activation
Industry statistics show that most delays in opening a clinical trial occur during the start-up process. From preparing detailed regulatory packets for IRB submission, to negotiating an appropriate budget, to ensuring all costs are covered, the administrative functions for opening a trial are time consuming. With limited resources, these start up services can take up even more valuable staff time.
Click the items below to view additional details about our ATA Services
Budget and contract negotiations are an integral part of trial start up. GuideStar takes pride in our ability to work with sponsors to communicate the financial expectations for trial start up fees, as well as per patient payments. You can also count on GuideStar to ensure contract language protects your organization and clearly describes payment terms. The financial team at GuideStar is experienced and certified in trial contracting and works diligently to negotiate the best possible financial arrangement on behalf of our client.
A coverage analysis is a Best Practice for the start up of each and every clinical trial in which a third-party payor may potentially be involved. During coverage analysis, GuideStar will break down your program’s study budget to its finest detail, ensuring you are covering your costs and have a clear method for billing compliance.
GuideStar’s team of experts will make sure there are as few budgeting surprises as possible throughout the entirety of the trial.
Clinical trials must go through regulatory processing at the local, sponsor and IRB levels to ensure all requirements are in place to protect human subjects participating in the trial. GuideStar’s specialists will manage the initial regulatory processes, including working with your staff and Principal Investigators to complete documents required of the site, and manage the submission of all materials to the trial sponsor and IRB.
Your certified and experienced GuideStar team will develop efficient workflows and communication mechanisms resulting in expedited regulatory processing.
What GuideStar’s Accelerated Trial Activation services line means for you:
A reduction in staff time devoted to non-revenue generating administrative tasks
Budgets and contracts negotiated by research experts
A coverage analysis document that meets the highest standards for compliance
Assurance that all site costs are being met and all protocol changes are being addressed
Financial peace of mind