"Before working with Divergent S.P.E.E.D., we were struggling with recurring audit findings during FDA and EMA inspections. Their team conducted a thorough mock inspection, provided detailed training, and helped us close gaps we didn’t even know existed. Thanks to their guidance, our next audits went smoothly with far fewer observations, and our sponsors have greater confidence in our processes."
"We were having a lot of trouble keeping our TMF documentation consistent across international sites. Divergent S.P.E.E.D. stepped in, standardized our processes, implemented a digital tracking system, and trained our teams. Now, our documents are complete, our audits are stress-free, and reporting has never been easier."
"Managing multiple vendors across several trials was overwhelming and we kept running into protocol deviations. Divergent S.P.E.E.D. developed a clear vendor oversight system with KPIs and regular audits. They helped us catch issues before they became problems, saving us time, money, and headaches."
"As a small team, aligning our operations with global GCP and regulatory standards felt impossible. Divergent S.P.E.E.D. performed a full gap assessment, gave actionable recommendations, and trained our team. Their support was invaluable — our inspections went flawlessly, and we now operate with confidence and efficiency."
"We were struggling to get consistent oversight on our international trial sites. Divergent S.P.E.E.D. came in, assessed our processes, and implemented a monitoring framework. Their guidance improved our site compliance and communication, and we completed the study ahead of schedule with no major regulatory issues."
"Our team lacked clarity on regulatory expectations across different countries. Divergent S.P.E.E.D. provided step-by-step support and customized training. Their advice helped us navigate complex regulations, and our trial approvals went smoothly without delays."
"We had recurring data discrepancies and risk management challenges that slowed our studies. Divergent S.P.E.E.D. audited our operations, identified critical gaps, and trained our staff. The improvements were immediate — data quality and reporting accuracy have never been better."
"We were unsure how to prepare for our first FDA inspection. Divergent S.P.E.E.D. walked us through every step, conducted mock inspections, and provided clear guidance. The inspection went flawlessly, and we avoided months of potential setbacks."
"Managing global audits for multiple sponsors was overwhelming, and we kept missing deadlines. Divergent S.P.E.E.D. introduced streamlined tracking and quality oversight tools. Their expertise allowed us to meet all regulatory expectations efficiently, and our audits are now stress-free."
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