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On Wednesday, DrugDev is debuting its Site Activation Module at the SCOPE Summit. The company believes the module will greatly improve all tasks of site activation, from protocol feasibility, site identification and selection, to contracts and the collection of site regulatory documents.
On Wednesday, DrugDev is debuting its Site Activation Module at the SCOPE Summit. Part of the DrugDev TrialNetworks technology platform acquired two years ago, the company believes the module delivers a revolutionary process for everyone involved in site activation.
Site activation tasks include protocol feasibility, site identification and selection, contract and budget negotiation and the collection of essential site regulatory documents. Budgeting, which still needs a negotiation and separate set of documents, is not included but is improved because of the transparency of the system for investigators, sponsors and CROs.
These stakeholders will now use single sign-on to access the DrugDev TrialNetworks platform to access a dashboard for a comprehensive view and way to manage active trials.
Melissa Easy, Founder of DrugDev and President of SiteStart, told Applied Clinical Trials that site activation, part of the study start-up process, is painful because of the huge administrative burden on sites and sponsors. This includes mapping multiple Excel spreadsheets, along with accessing the numerous portals that sites have been forced to work on for inputting the same documents over and over. Easy said, “Most sites say, ‘not another portal’ but they really like this when they use it.”
While single sign-on is a good thing, what really makes the platform robust is the integration with other information in the DrugDev data platform, accessed via the “Golden Number.” The DrugDev Golden Number is a unique identifier for investigators, site personnel and facilities. When combining the DrugDev platform, the Golden Number and the company’s global network of over 80,000 investigators, all the information for site activation is easily located.
It also eliminates redundancy by allowing sites to update their information in the DrugDev network, where changes are fed automatically into all DrugDev solutions. It also pre-populates all the documents that the site needs for contracting and regulatory. In addition, the contract side 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.
For CROs, it can immediately see if a Master Trial Agreement exists for a site it has chosen via the platform’s feasibility process. It also eliminates the duplication of investigators, because the system recognizes and verifies if John Smith or J Smith are the same person.
Easy and the rest of the DrugDev team will be at SCOPE presenting on site issues, as well as demonstrating their new product. Easy, a self-proclaimed “Site Activist,” is enthusiastic that industry will appreciate the solution. “It is fully customizable and flexible, and a true global solution as it includes all country-specific paperwork. It is the same solution that we have been using internally, and now we have it available for our clients.”