简化从方案设计到监管提交的临床试验工作流程

Streamlining the Clinical TrialWorkflowfrom Protocol Designto Regulatory Submission Use Case| Streamlining the Clinical Trial Workflowfrom Protocol Design to Regulatory Submission The situation A sponsor in the early stages of planning a breast cancer clinical trial wanted to addresspotential stumbling blocks from the start. Its main concerns were costly protocolamendments and clinical trial regulatory submission, two areas at either end of the clinicaltrial life cycle that could threaten to disrupt the study’s aggressive timeline. Our approach For many pharmaceutical companies, clinical operations and clinical disclosure teamstypically work in silos. That’s why this sponsor turned to Citeline, whose solutions spanthe R&D spectrum, from clinical trial design to patient engagement/recruitment toclinical trial disclosure. Use Case| Streamlining the Clinical Trial Workflowfrom Protocol Design to Regulatory Submission The process The Citeline-Risklick partnership gives this sponsor gets the best of both worlds. BothCiteline and Risklick harness the power of AI to refine the protocol design process. Protocol SmartDesignmines Citeline’s Trialtrove and Sitetrove data for successfultrials similar to the sponsor’s. It then instantly generates primary endpoints andinclusion/exclusion criteria for the sponsor’s trial.Risklick’s AI platformuses theserecommendations to rapidly design a high-quality protocol. Use Case| Streamlining the Clinical Trial Workflowfrom Protocol Design to Regulatory Submission But the efficiencies don’t end there. When the sponsor is ready to submitits protocol to regulatory agencies, the AI Importer feature ofTrialScopeDisclosetakes over.AI Importerdoes more than simply import the protocolinto TrialScope Disclose — it automatically maps relevant data to thecorresponding fields in the submission form. Use Case| Streamlining the Clinical Trial Workflowfrom Protocol Design to Regulatory Submission And, with theGlobal Disclosure Formin TrialScope Disclose, the sponsor can prepare,approve, and submit to multiple registries all in one unified platform. The difference Unlike many other clinical trial disclosure solutions, which only offer a clinical trialmanagement system (CTMS), Citeline offers sponsors the clinical component. By creatinga direct line from clinical planning/protocol design to clinical trial disclosure, Citeline helpssponsors optimize the entire process. Use Case| Streamlining the Clinical Trial Workflowfrom Protocol Design to Regulatory Submission The benefits Thanks to Citeline’s holistic approach, the sponsor can realize efficiencies from start to finish. What this means for the sponsor: Accelerates the entire clinicalplanning process Reduces burden on staff Improves communication betweenClinOps and Disclosure teams Avoids costly, time-consumingprotocol amendments Promotes consistency and minimizeserror in regulatory submissions Boosts likelihood of clinical success 6January 2026Copyright © 2026 Citeline, a Norstella c ompany. ( U nauthorized p h otocopying p rohibited.)Discover how TrialScope Disclose takes thetedium out of regulatory submissions. About Citeline Citeline, aNorstellacompany, powers a full suite of complementarybusiness intelligence offerings to meet the evolving needs of lifescience professionals to accelerate the connection of treatmentsto patients and patients to treatments. These patient-focusedsolutions and services deliver and analyze data used to driveclinical,- commercial-, and regulatory-related decisions and createreal-world opportunities for growth. Citeline’s global teams of analysts, journalists, and consultantskeep their fingers on the pulse of the pharmaceutical, biomedical,and medtech industries, covering them all with expert insights: keydiseases, clinical trials, drug R&D and approvals, market forecasts,and more. For more information on one of the world’s most trustedhealth science partners, visitCitelineand follow onLinkedInandX.