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ScienceMedia’s Protocol Compliance Management Solution Solves Challenge of Leading Site in Clinical Trials

Chief Strategy Office, David Turn states, “What might initially be perceived as a simple two-armed study can quickly turn into dozens of documents and hundreds of regulatory filings that every site personnel, including newly hired personnel, are required to consume. There are protocols for each arm, a brochure for the investigator, as well as documents for pharmacies, laboratories, imaging, randomization and data entry.These can be in several languages, with modifications To help with turnover, SMi test provides a central resource for all staff from start to finish and includes compliance records. A recent trial using SMi test at more than 400 hospital sites, site staff reported accessing information 100,000 times per month. Due to multiple versions of documents and protocols, just under 30,000 completion records were recorded.

SMi trials Proven protocol compliance management approach supports sites in multiple countries. Not only SMi test actively train sites at start-up, but it serves sites throughout the life of a clinical trial, ensuring that each site is protocol compliant through amendments, while addressing the turnover of the personnel and quickly integrating new employees.

SMi test has proven time and time again that protocol compliance management is not only a vital solution for site compliance, but also for improving data quality while reducing query time.

Turner continues, “Protocol compliance management is extremely important for onsite and decentralized trials. Keeping all constituents in compliance with protocol is paramount to ensuring the success of a clinical trial, completing it on time or even earlier than expected. Through our compliance with risk-based study and management training protocol, we have repeatedly seen that it reduces site start-up times, addresses staff turnover issues and significantly improves the quality of data. »

For more information on how ScienceMedia’s Protocol Compliance Management solution can benefit your trial, follow ScienceMedia via LinkedIn or our blog.

About Science Media
ScienceMedia enhances clinical skills through innovative multimedia learning solutions. SMi testfor on-site testing, and SMi testD, for decentralized or hybrid trials, are protocol compliance management solutions that mitigate clinical risk and lower the cost of trials. Source SMi provides just-in-time, fully-referenced information on diseases and clinical trial topics through a cloud-based, mobile medical science library with over 16,000 micro-learning topics and over 400 comprehensive courses.

Jen Pfau
[email protected]
(805) 452-1795