Clinical Development & Protocol Strategy

“Build and test inclusion/exclusion criteria impact on patient populations, identify optimal sites, and reduce protocol amendments before they occur.”

“…Before a protocol is finalized, we conduct a thorough operational feasibility review to assess whether the design is realistic given the available patient population, site…”

“Experienced in the ethical and regulatory requirements of North America, Europe and Asia, we offer a global solution to your protocol development needs, from conceptualization to…”

“Our protocol optimization methodology translates your complex, scientific and regulatory document into a streamlined, interactive patient journey simulation, including site…”

“Identify referring providers and specialists, analyze treatment timelines, and use actual patient counts to inform protocol design, site selection, and enrollment projections.”

“Expert-designed and data-informed clinical trial protocol development”

“…Tailored clinical protocols design. Acts as an interface between Sponsors and CROs/CMOs, aiding in the selection of contractors with proven success”

“Our team designs forward-thinking yet executable studies, collaborates with subject matter experts, and develops study synopses and schedules.”

“Test inclusion and exclusion criteria against de-identified patient records to see how each one moves the eligible pool.”

“…Protocol and Trial Design”

“Design protocols from the start that enhance the patient experience & speed up enrollment”

“Protocol design, endpoint and comparator selection, KOL and advisory panel development, and adaptive design approaches built to meet your trial's objectives.”

“Consulting on clinical trial design while ensuring compliance with specific regulatory requirements for IVDs.”

“Design your clinical trial for success with strategic regulatory guidance from our experienced team, accelerating your path to market.”

“ZS Trials.ai sets you up to make scientifically informed, study-related decisions while addressing protocol issues and reducing amendments.”

“Protocol design and endpoint selection aligned to EMA and FDA requirements”

“Our clinical pharmacologists perform background research, and consult with research specialists, to ensure we craft the ideal, customized design to meet your POC objectives…”

“We can help you streamline your protocols for success with IQVIA’s unparalleled data — leveraging AI, automation and data captured at the point of care so you can design smarter…”

“Trial design and protocol optimization”

“Study design, protocol development, sample size calculation, statistical analysis planning, subject randomization, table and graph design, and report writing”