It’s no secret that clinical trials have become significantly more complex over the past decade. Today’s trials often include multifaceted protocols, new and different eligibility criteria, and more advanced laboratory testing than was little more than a dream 10 years ago.
Unfortunately, the tools available to clinical trial sites to help them manage these more complex trials have been unavailable until now. Even so, most contract research organizations (CROs) and clinical trial sites are still using antiquated processes and paper forms for everything from subject enrollment to sample chain of custody to test result reporting.
PPD® Laboratories’ central lab is changing that with its latest innovation, the Preclarus® investigator site portal. The portal is a web-based platform that helps clinical trial sites manage their PPD Laboratories’ trials from start to finish. The portal automates and streamlines routine tasks such as subject registration, sample tracking and test result reporting.
“We want to listen to our clients and sites to bring their ideas to fruition in the clinical trial space,” said Chris Clendening, executive director of project management and design for PPD Laboratories central lab. It is essential for investigators and clients to have a comprehensive clinical data solution that ultimately consolidates data from multiple sources, he said.
Before the Preclarus investigator site portal, there was no way to establish a clear chain of custody for samples at the site, Clendening said. Clinical sites and the central lab operated in silos. Sites collected and shipped patient samples without a way to notify the recipient that samples were on their way. With Preclarus, any recipient would have visibility to incoming samples in real time and can prepare or schedule resources for their arrival. This not only provides an early warning for samples detained or lost in shipment, but the recipient and client can use that additional visibility for test scheduling and to improve turnaround time.
The new portal reduces data discrepancies by up to 80% through its online accessioning capability. Without this portal, each discrepancy raises questions that take time to be resolved and cause testing delays. “The Preclarus investigator site portal eliminates the discrepancies that can accompany paper requisitions, and helps drive sites to answer the right questions at the right time,” Clendening said. “It establishes an electronic line of communication between the central lab and the investigator site, which helps to streamline trial management.”
PPD’s advantage over competing CROs is that it owns a lab and is better suited to exchange data with investigator sites without an intermediary, said David Stein, an independent eClinical consultant.
The chain of custody is likely stronger for PPD than its competitors because of its lab specialty, said Stein, who used to work for CROs. Being more closely tied to the lab, PPD can be more efficient handling lab processes such as providing lab kits and supplies, managing inventory, tracking samples from the clinical site to the lab, and making lab results available quickly, he said.
“The upshot is that all the lab data is proactively reconciled with other data streams. This can save a great deal of time at the end of the trial during data cleaning and database lock.”
The Preclarus investigator site portal offers a suite of tools that provides better online management of trials with access around the clock, Clendening said.
Continuous access is especially important for one clinical research coordinator who participates in trials in Nevada using labs on the East Coast. This research coordinator likes being able to download lab reports to document that samples have been received and processed when it’s convenient for her, even when the lab across the country could be closed.
With other central labs, the research coordinator has to call them when they’re open to confirm that samples have been received or to check on their progress. “We are not usually able to see if specimens were received on my time. It’s vital that the samples are safe and everything is done correctly,” she said.
“We currently are using five other vendors and Preclarus allows access in a way that I can’t access with any other vendor. There is no other portal like it for studies. Others are not as comprehensive. They don’t have the range of access.”
In this way, the research coordinator believes PPD put a lot of effort into making Preclarus user-friendly for clinical coordinators and principal investigators.
Among the online management tools the Preclarus investigator site portal delivers are those that:
- Simplify subject registration with real-time error checking and online query resolution
- Provide online accessioning capabilities to establish chain of custody before the samples leave the site
- Eliminate paper requisitions
- Facilitate patient management and safety with real-time access to study details, patient data and lab results
- Provide online ordering of sample collection kits
- Show and improve inventory management
- Track supplies and sample shipments
- Offer an embedded news ticker to communicate study-specific information more effectively
Such data solutions help fulfill the U.S. Food and Drug Administration’s vision for using digital technology along the entire clinical trial path, said Dr. David Lee Scher, a cardiologist and digital health technology consultant. The Preclarus investigator site portal fills a need that should be a standard of care for clinical trials, ultimately doing the right thing for the patient, said Scher, also a former clinical investigator and longstanding Institutional Review Board chair. “It should be something that's looked at as expected across the industry.”
The Preclarus investigator site portal is the most recent innovation for clinical trial management from PPD Laboratories. But, according to Hacene Mekerri, VP of Operations for the company’s central lab, “We are committed to bending the cost and time curve of pharmaceutical development with innovative tools that help sites, project teams and our clients make faster, more informed decisions about their compounds.”
Mekerri, who has 20 years’ experience with CROs and their data solutions, said PPD Laboratories is leading the industry in this regard and aims to stay ahead of competitors, starting with plans to introduce additional tools that will improve communication between project teams and clients, and provide better visibility to key performance indicators and cost drivers.