Pharmaceutical Product Development (PPD) and CISYS LifeSciences have announced the implementation of Sequence WebEAS, a new Web-based event adjudication system (EAS) that PPD maintains can improve the process used by principal investigators to examine and adjudicate safety events.
Initially developed by CISYS as a platform for clinical research data capture with a new module co-designed in partnership with PPD, Sequence WebEAS software is designed to be comprehensive system that automates and captures all activities, documents and data required to evaluate a clinical trial event such as a heart attack in a cardiovascular study. It is designed to reduce the administrative burden needed by PPD and its biopharmaceutical clients to collect, measure and prepare dossiers for presentation to EACs. The company claims that using the Sequence system eliminates the need to find and juggle detailed paperwork, so investigators can focus on the safety issues using the software’s dashboards and electronic classification forms.
Under its agreement with CISYS, PPD will implement Sequence WebEAS into its clinical processes and offer it to its client roster, which includes some of the largest biopharmaceutical companies.
“The use of event adjudication committees to adjudicate research endpoints is steadily growing, driven by expanding safety requirements, especially those aimed at more rigorous evaluation of cardiovascular risk,” said Cindy Elko-Simms M.D., PPD’s vice president of pharmacovigilance. “PPD’s subject matter experts engaged with CISYS to develop a Web-based event adjudication software application that was more robust in metrics reporting and more efficient in dossier compilation than other existing applications serving the same function.”
The Sequence WebEAS data import function automates the event identification process to automatically pull in event/patient data from various electronic data capture (EDC) systems, according to PPD. Once in the system, the software adjudication workflow process automates document collection, dossier, preparation, EAC committee selection and scheduling, and dossier distribution.
Historically, EACs—which also are referred to as “endpoint adjudication committees” and/or “Data Safety Monitoring Committees”—have been individual CRO project teams, according to Jim Saunders, president of CISYS LifeSciences. As an emerging support tool in the modern clinical trials environment, the system’s built-in flexibility also enables various EAC models and workflows, he said.
“The need for adjudication committee is relatively recent, as the FDA has increasingly requested firms to do more adjudication,” said Saunders. “That’s due to some medications where there were unaccounted clinical events that harmed some people, which led to greater use of adjudication committees.”
Both PPD and CISYS maintain that having a comprehensive software system frees committee members to focus on their reviews, as the process enables the system to improve efficiency of activities and quality by maintaining consistency.
“This may not be an exact number, but there is about a 40% time savings with the Sequence software over the manual process of assembling the data,” said Saunders, who added that the company plans to directly offer its Sequence platform to other CROs, academic research organizations, and sponsors including biopharmaceutical and medical device companies.
PPD’s partnership with CISYS is among a series of recent developments to expand its presence on the global market for research and development. Late last year, PPD partnered with eResearch Technology (ERT), a data collection expert specializing in clinical services and customizable medical devices for biopharmaceutical and healthcare organizations that also collects, analyzes and distributes electronic reported outcomes (ePRO) in all phases of clinical research.
Twelve months ago, PPD acquired discovery-focused firm X-Chem in a purchase designed to strengthen its early-stage capacity. That deal was preceded in 2013 with the acquisition of Acurian, a technology provider focused on clinical trial enrollment and retention services.
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