Banner Ad

Using Technology to Streamline Clinical Trial Start-Up

Photo credit: Depositphotos

By Catherine Gregor, MBA, CCRP, CCRC

Around 70% of clinical trials experience start-up delays that last one month or more, and recent data suggests that study start-up takes an average of eight months. Cutting back on these delays could help sites finish their trials weeks earlier and save sponsors between $600,000 and $8 million

- Advertisement -

But why do start-up delays happen? Sponsors and sites can blame a variety of factors, including prolonged contract and budget negotiations, delayed regulatory approvals, and inefficient implementation processes. 

Though clinical trial software can’t eliminate the need for negotiations, it can help with regulatory approvals and communication between sites and sponsors. The research sites Florence works with decreased their start-up time by 40% when they started using technology for document management and site-sponsor connection. Here’s how. 

Where Tech Can Help with the Study Start-Up Process

Study start-up is a complex process. It involves communication between the sponsor, the CRO, and the site, equipment management, drug or device inventory, management of ancillary clinical services, and hundreds of documents: all before a patient is ever recruited.  

After working with more than 10,000 research sites, CROs, and sponsors, Florence has identified three key areas of study start-up that software can help with: 

  1. Regulatory document collection and submission
  2. TMF setup and implementation
  3. Site and sponsor integration

An electronic Investigator Site File (eISF) can speed up regulatory document collection at the site by eliminating the need for wet-ink signatures and paper management. An eISF will also set the site up for remote monitoring. Sponsors and CROs can receive similar benefits by relying on electronic Trial Master Files (eTMFs) instead of paper ones. 

But eISFs and eTMFs alone won’t make study start-up more efficient. Sponsors need remote access to their sites’ documents and data, and sites need the ability to control which documents and data their sponsors can see. This is why building an integrated system is a valuable—and ultimately time-saving—part of the study start-up process. 

1. Speeding Up Regulatory Document Collection and Submission

ICH E6 (R2) regulations declare that a sponsor can’t send a clinical trial site the study drug or device until all regulatory documents are completed correctly. Finalizing these documents via email can take weeks, especially if a site or sponsor has strict SOPs. 

An error on an informed consent document, 1572, or financial disclosure form could cause days of delays and prevent sites from opening in real time. Well-designed software can help sites and sponsors communicate about and complete regulatory documents more quickly. 

2. Creating, Organizing, and Signing Documents

An eISF gives sites a secure online space where they can quickly organize all of their study documents with electronic folders, placeholders, and task reminders. These features let sites manage their documents in real-time and generate reports and audit trails. 

Some eISFs may also include form templates and fillable forms that allow research professionals to create their documents entirely online. Clinical Research Coordinators (CRCs) will no longer have to print or copy dozens of documents and then scan and email them to sponsors.

Another major time-saver? Instead of driving or running across a busy hospital campus to bring paper forms to a Principal Investigator (PI), a CRC can send forms that need to be signed directly to a PI’s phone or tablet. The PI can then sign quickly at home, on the way to work, or in between patient appointments. 

To use eSignatures, sites need to make sure their eISF aligns with FDA 21 CFR Part 11, EU GMP Annex 11, and other federal or local regulations around eSignatures. Fortunately, most reputable clinical trial software companies understand these regulations. They should be able to explain how their software follows them and provide guidance on local implementation. 

3. Staying Compliant

In addition to offering Part 11 or Annex 11-compliant eSignatures, well-designed eISFs can provide features like central document linking and monitor review modules. Central document linking allows clinical research coordinators to update one document and have those changes show up in every folder where the document is stored. 

Version control and audit trails can also help CRCs keep track of when a document has been updated and who updated it. These features make it easier for sites, sponsors, and regulatory agencies to review the most recent version of any form as well as its history.  

With monitor review modules (MRMs), sites can give their monitors access to the most recent versions of their documents and data. The monitor can quickly see if documents are missing or incomplete and let the site know what they need to update within the eISF. Sites can make those updates and let sponsors see the changes instantly, reducing the need for multiple regulatory submissions.

One research site reported that they used to redo their paper regulatory submission 35% of the time. After switching to an electronic system, they only had to redo their regulatory submission 1% of the time. Their study start-up process is now shorter for almost every trial they run, which will enable them to open more trials and enroll patients faster. 

4. TMF Setup and Implementation

Paper TMFs give sponsors and CROs little visibility into the site start-up process. They also force sponsors to rely on external communication methods like email, fax, and postal mail. 

On the other hand, using an eTMF for study start-up offers many of the same benefits for sponsors that using an eISF offers for sites. eTMFs help sponsors and CROs create, organize, and sign their documents in real time. 

Perhaps the main benefit of an eTMF is the ability to distribute folders, documents, templates, and placeholders to sites. A good eTMF doesn’t just help sponsors organize their own documents. It helps sites set up their regulatory documents and folders quickly. 

By distributing folders to sites, sponsors can ensure that all of the sites in a study use an organization system that’s easy for monitors to understand. Monitors can also assign tasks or due dates to sites to help them complete the start-up phase on time. If a monitor notices a site is falling behind, they can reach out to them before they miss any more start-up deadlines. 

One of the sponsors in Florence’s network used this tactic to conduct clinical trials on neurodegenerative diseases. During study start-up, the sponsor distributed eISFs across 54 study sites.

The sites controlled their own eISFs and gave their sponsor permission to view select documents. The sponsor could then easily load relevant documents and data into their eTMF. This process reduced the cost of the trial by 30% and the amount of time spent on the trial by 50%. 

5. Site and Sponsor Integration

Sites can accelerate study start-up using eISFs, and sponsors or CROs can accelerate study start-up using eTMFs. But to achieve maximum efficiency, sites and sponsors need an integrated system that lets them share documents and data with each other. This means finding software with an open API. 

When sites and sponsors use disconnected software, research professionals often end up repeating their work. A CRC might create a document in one program and have to log into a completely different program to share that document with their monitor. This wastes time and resources during study start-up. 

An eISF or an eTMF with an open API can integrate with any other software that has an open API. This integration makes it easy to share documents between programs without having to log out of one and into another. 

However, an integrated ecosystem doesn’t mean that sites and sponsors will have access to all of each others’ documents. Rather, sites will control their eISF and give sponsors access to specific documents and data within it. 

Meanwhile, sponsors will maintain their own eTMF but have the ability to distribute documents to sites. They’ll also have the ability to monitor sites remotely using the eISF access that sites have granted them. 

A recent case study on this integration found that one oncology physicians’ network used software to send out “study start-up kits” to 168 research sites in their network. Sites used these kits to organize their regulatory documents in their private eISFs. Then, they gave their coordinating centers access to relevant documents. This led to a 41.8% reduction in document cycle time during study start-up. 

Make Your Study Start-Up Process More Efficient with Tech

By cutting down on study start-up delays, sponsors could save hundreds of thousands of dollars and get effective treatments to patients faster. Sites will also win more studies if they can offer sponsors a faster start-up process. 

eISFs and eTMFs help sites and sponsors manage documents without time-consuming manual tasks like printing, copying, scanning, and filing. But to prevent compliance errors and streamline communications, sponsors and sites need integrated software that lets them instantly share notes, data, and documents with one another. 

Want to learn more about software for study start-up? Check out Florence’s Complete Guide to eRegulatory and eSource for an in-depth exploration of how technology can speed up clinical trials. 

Catherine Gregor is the Chief Clinical Trial Officer at Florence, the industry leader in remote connectivity in clinical research with more than 10,000 study sites across 40 countries. She has more than 15 years of experience analyzing and implementing change across back-office research operations for finance, clinical operations, regulatory and health information systems. She has worked in a myriad of community and academic environments. Most recently, she served as the Director of Clinical Research Administration at the Vanderbilt-Ingram Cancer Center.

Healthcare Business Today is a leading online publication that covers the business of healthcare. Our stories are written from those who are entrenched in this field and helping to shape the future of this industry. Healthcare Business Today offers readers access to fresh developments in health, medicine, science, and technology as well as the latest in patient news, with an emphasis on how these developments affect our lives.

- Advertisement -

Related Articles

Latest Articles