By Clinical Informatics News Staff

February 22, 2016 | DrugDev will announce a new module for its cloud-based DrugDev technology platform this Wednesday at the Summit for Clinical Ops Executives, SCOPE, in Miami, Fla.

The Site Activation Module delivers faster and more reliable site activation through flexible workflow customization technology, document exchange, transparency and collaboration, contracting, and essential site regulatory document collection.

“It’s taken our experience in site activation that we’ve had as a company for a while, and combined it with the platform TrialNetworks,” explained Melissa Easy, DrugDev’s founder and president of the company’s SiteStart division, in a conversation last week. “It’s really just melded this amazing operational experience and IT experience, which is why I’m quite excited. Normally it’s just one or the other.”

“Site startup” is an ever-morphing term, Easy said. The Site Activation Module encompasses feasibility, budget negotiations, clinical trial agreement negotiations, collections and maintenance.

“The system was built to make everything easier for the sites, because I think that is something we really do get wrong,” Easy said. Site Activation Module, she added, “[is] super, super flexible, because every study is different, every country is different…but the workflow customization actually allows for that not to be a problem at all.”

The new module is integrated in all of DrugDev’s other offerings.

Sponsors, CROs and investigators use DrugDev’s single sign-on process to access the module within the DrugDev TrialNetworks platform for a comprehensive view and to manage all active trials. This streamlines workflow and makes outstanding activities clearly visible, thereby greatly reducing the administrative burden on both sites and sponsors.

DrugDev’s Golden Number, a unique identifier for site personnel and facilities drawing from DrugDev’s database of 80,000 investigators, lets customers find the right investigators, execute contracts, collect essential regulatory documents, and quickly activate trials.

Workflow processes include automated checklists, action flags and document exchange. Notifications arrive conveniently bundled in one email, which summarizes all tasks and takes the user directly to the items on their activation checklist, like a virtual post-it note or to-do list.  The module incorporates a Document Library, FAQs, News page, real-time dashboard and reporting, Checklist, Maintenance, Site Activation, and real time Study metrics and Administration in a central repository for easy access.

Dashboarding capabilities enable sponsors and CROs to track, view and report on multiple studies with a single sign-on and sophisticated permissions. This expedites feasibility studies, site activation, payments and other key activities across their clinical pipeline. Site contracting becomes more efficient with historical contract terms provided, collaborative inline editing, secure document exchange, and trackers automating the contracting and essential site document collection process. Workflow optimization is easily customized to reflect sponsor internal practices, and transparent reporting across all active trials allow sponsors to easily track progress and identify challenges and bottlenecks.

Some new DrugDev clients have been using the module for recently started studies, but the announcement this week at SCOPE will mark the technology’s widespread availability.