Clinical trials have become more and more complex over the last decade, largely due to the challenges driven by an increasingly global reach. As a sponsor, are you making it hard for clinical trial teams? Learn about a unique solution to managing clinical trial binders.
A Challenging Part of Study Startup – Clinical Trial Binders
Since 2016, the highest number of clinical research registrations on clinicaltrials.gov include clinical studies with sites in the Western Pacific, Europe, and Latin America. This spread of global clinical trial activation continues as recruitment efforts increase in lower-income regions and those with unmet medical needs. Clearly, the complexity phenomenon isn’t going away. It’s a challenge that study teams face, especially as they undertake the critical steps of study startup.
Investigator Site File (ISF) and Pharmacy binders are a requirement for all clinical trials in the study startup process, and clinical trial sites are faced with meeting each country and region’s regulatory requirements regarding what to include. These binders contain key study information, including:
- Protocol requirements
- Inclusion and exclusion criteria
- Regulatory requirements that impact the clinical trial
Binder Burden
Step one is the creation of a master set of clinical trial documents. From there, documents for study startup are adapted to each site, country, and region based on regulatory and governmental needs. Thirty percent of studies are U.S. only, and 54 percent are based outside of the U.S. With 66 percent of studies recruiting globally outside of the U.S., these documents must be revised frequently. The burden this places on study teams can be enormous.
And it’s often a race. Finalizing the study materials and adapting them to include site-specific documentation is often very last minute, with only a week or two available to make final ICF and Pharmacy clinical trial binder files ready to include within the binders. This burden typically falls on local site teams and clinical trial managers to finalize and generate these documents at a site level.
Research sites’ startup fees may not be enough to cover their time, and clinical trial managers may not bill correctly for the steps, time, and work involved. This is not cost or time-effective. It creates animosity between site teams, wider project support teams, and sponsors, and most importantly, it doesn’t provide the full accounting and audit of each step involved in the study startup. We found that local teams spend an average of 6-7 hours customizing clinical trial binders per study country. This has been the norm for a very long time.
Clinical Trial Binders: An Imperial Solution
One of our clients approached us to discuss these challenges and see if we could find a solution to enable a smooth provision of study startup materials for global site locations. This was a challenge, of course. The development, printing, and shipping of the materials would need to be:
- Centrally managed
- On demand
- Flexible
- Adaptable
- Immediate
Our business development, operations, project management, prepress, and production teams worked together. Using our proprietary digital platform, we created a unique solution for site-specific clinical trial binder development and printing. This exciting process does several things:
- Provides sponsors, CROs, and their study teams with greater control of their binder projects, supported by our dedicated project management team.
- Removes the need for multiple localized solutions that require contracts, vetting, auditing, and managing.
- Allows CROs to focus local country resources on other important elements of study startup, as well as monetize previously unbilled time for the development of the customized binders.
- Gives our clients all over the globe the quick, flexible, dynamic solution that they need.
- Improves the satisfaction of clinical trial sites.
In addition, our clients benefit from free warehousing, a 24/7 portal for file uploads, digital proofs, inventory management, and shipment tracking. That’s just a few of the many reasons our clients have adopted and implemented this solution.
The Imperial Advantage
The burden on project teams and local site teams increases exponentially with the growing global footprint of clinical trials. It’s part of Imperial’s core goals to do the right thing for our clients. By creating this solution to meet the needs of our clients and, in turn, reducing costs and time, we hope we are exceeding their expectations. And exceeding expectations is one of our corporate goals.
We are in the solutions business. Let us know your pain points, and Imperial will work with you on a solution.
_________
Sources:
World Health Organization data on trials by year, country, region, and income group
ClinicalTrials.gov information: trends, charts, and maps
