Carolina Fass, Executive Director and Liene Rondi, Director and Maria Helena Vidotti, MD, Principal Investigator in CardiologyThis reliability is critical in the competitive Latin American market, where the clinical research environment is entering a period of expansion. Although sponsors now have access to a broader network of research sites across the region, experienced teams capable of consistently delivering quality recruitment, reliable data and strong patient service remain hard to find.
i9 Pesquisas Clínicas distinguishes itself in this landscape through a quality-driven approach to trial execution. By prioritizing careful patient selection and clinical data integrity, it brings the scientific rigor and flexibility needed to support reliable study outcomes.
“Sponsors have a lot of sites to choose from, but not many that consistently deliver quality patient recruitment and service together. We believe that's what makes us different,” says Carolina Fass, executive director.
A dedicated clinical research site, i9 supports Phase II, III and IV trials. It works with leading global pharmaceutical companies and CROs, managing every stage of trial execution, from feasibility assessments and regulatory submissions to data reporting and study close-out. The organization’s strong local presence in Campinas, Brazil—a strategic healthcare hub—combined with modern, well-equipped research facilities, enables high-performance clinical trial execution.
We Go Above And Beyond To Adapt To Sponsor And Patient Needs. Fast Responses, Flexibility And Quality Are The Characteristics They Value, And That's What We Deliver.
i9 started in cardiovascular research, which remains one of its strongest areas of expertise. Building on that foundation, it expanded into gastroenterology, where it developed significant experience in inflammatory bowel conditions like Crohn’s disease, ulcerative colitis and esophagitis.
The strong clinical overlap between cardiovascular disease and metabolic disorders prompted i9 to extend its focus to diabetes, overweight and obesity trials. With sponsor investment continually growing in pulmonology and dermatology treatments, it is now strengthening the operational and investigator capacity required to support a broader pipeline of studies.
Experienced Teams, Consistent Execution
Combining deep clinical expertise, strong regulatory know-how and a patient-centered mindset, i9 has consciously built its reputation around delivering reliable data and an experience that benefits sponsors and study participants alike. High-quality standards are woven into daily operations, shaping decisions across the organization.
Numerous team members have been with i9 for more than 15 years, bringing a level of continuity increasingly rare in an industry with high turnover. The long-tenured workforce preserves the institutional knowledge required to manage complex protocols, support patients effectively and deliver consistent results.
Patients experience i9’s clinical expertise throughout the trial. Everyone receives close medical follow-up from multidisciplinary teams that prioritize safety and clear communication. Positive patient experiences support participant retention, protocol adherence and the collection of reliable clinical data throughout the study.
Delivering End-to-End Reliability
At i9, projects begin with a comprehensive feasibility assessment evaluating patient availability, site capabilities and alignment with protocols. Early feasibility discussions provide sponsors with timely, accurate information that aids study planning and contributes to the scientific value of the research.
Once the site is selected, attention shifts to regulatory preparation. Regulatory submissions are managed in accordance with Brazilian ethical and regulatory requirements. Standardized documentation processes facilitate efficient approvals. Internal autonomy over legal review and contract analysis removes the need for external committees or intermediaries, shortening start-up timelines and allowing studies to move forward more efficiently.
Throughout the trial, a multidisciplinary team manages recruitment, screening, enrollment and patient follow-up. All members are fully aligned and continuously trained to execute protocols efficiently, ensuring strict adherence to study requirements and high-quality data collection. At close-out, final data validation and reporting are performed in full compliance with regulatory mandates.
i9’s highly structured and robust organizational model helps improve alignment between sponsor expectations and project requirements throughout the study lifecycle. The trial site is led by two senior managers, each with over 20 years of experience, who oversee all studies across different therapeutic areas. They are responsible for orchestrating the involvement of PIs, sub-investigators and study coordinators, facilitating seamless integration across all functions.
Centralized communication and project oversight enable effective coordination among all stakeholders, supporting timely data reporting, transparent issue escalation and strict adherence to Good Clinical Practice guidelines. The integrated approach improves operational efficiency, reduces delays caused by misalignment and enhances patient safety.
i9 continually invests in strengthening its compliance framework to meet sponsor expectations and operate in accordance with applicable legislation and international guidelines. Over the past year, it conducted a comprehensive review of contracts, operational processes and SOPs to establish consistent operational standards for all team members, reinforcing accountability across the organization.
Strengthening Recruitment through Experience and Innovation
Recruitment has become a persistent challenge across clinical trials due to more granular patient profiles and stricter inclusion and exclusion criteria. i9’s recruitment strategy prioritizes finding the right patients and maintaining the personalized care that supports long-term participation.
At times, patient eligibility requirements prove more demanding than originally anticipated, requiring research teams to adapt on the go to protect the scientific integrity of the study. This challenge was evident in a cardiovascular outcomes trial evaluating a novel therapy for residual inflammation.
As screening progressed, identifying eligible participants proved significantly difficult, extending enrollment from the planned 12 months to nearly two years. Through expanded patient-sourcing efforts, stronger referral channels and a refined prescreening approach, i9 improved participant identification and minimized screen failures, sustaining recruitment momentum despite the extended enrollment timeline.
“We go above and beyond to adapt to sponsor and patient needs,” says Liene Rondi, director. “Fast responses, flexibility and quality are the characteristics they value, and that's what we deliver.”
I9’s recruitment expertise is underpinned by a dedicated patient recruitment department and a vast referral network of institutions and physicians serving Campinas and the surrounding communities. The network facilitates a consistent flow of potential participants, and referring physicians are closely aligned with the site’s processes and standards, contributing to recruitment targets while reinforcing patient confidence and trust.
Keeping its patient-centered focus intact, i9 continuously invests in innovation and technology to strengthen recruitment capabilities. The organization uses AI tools to optimize searches within internal databases and streamline communication with prospective participants.
Patient inquiries in Brazil are often received through WhatsApp, and i9 has automated the process to provide faster responses to prospective participants. A digital health questionnaire is also added to the platform, allowing participants to complete an initial self-assessment before their information is forwarded to the recruitment coordinator responsible for screening.
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Sponsors Have A Lot Of Sites To Choose From, But Not Many That Consistently Deliver Quality Patient Recruitment And Service Together. We Believe That's What Makes Us Different.
The technology is designed to remove administrative friction, not the human element of clinical research. Trained recruitment professionals remain responsible for screening potential participants and guiding them through the next stage of the process. Early implementation of the automated workflow has already reduced the staffing required to manage routine participant inquiries.
Preparing for the Next Generation of Clinical Trials
Brazil's new clinical research framework under Law 14.874/2024 is reshaping the environment, with the reforms expected to improve regulatory efficiency and create greater opportunities for participation in global trials.
i9 aligned its operations with the updated requirements by affiliating with an accredited Ethics Committee. The organization also expanded its operational capacity by recruiting pharmacists, nurses, technicians and administrative professionals. The investments are designed to strengthen site readiness, support faster study start-up and ensure improved accommodation for the increasing volume of global clinical research.
Expanding its clinical research portfolio across pulmonology and dermatology is a key priority for i9 this year. As sponsors advance numerous clinical trials in these therapeutic areas, i9 has principal investigators already in place to support relevant studies.
By combining operational flexibility with a culture of continuous improvement, i9 continues to refine the way it works with sponsors. Feedback from annual satisfaction surveys with sponsors and CROs is translated into improvements across operational workflows, patient experience and recruitment strategies. At the same time, a lean organizational structure allows teams to respond quickly to project-specific requirements, whether through customized infrastructure, budget flexibility or operational support.
i9’s recognition as the Top Pharmaceutical Clinical Research Solutions in Latin America 2026 reflects its ability to combine scientific rigor, operational flexibility and patient-centered care. These qualities position it as a reliable partner for sponsors seeking scientific rigor, operational agility and patient-centered execution in Brazil's evolving clinical research environment.
Evaluating Pharmaceutical Clinical Research Solutions in Latin America
Clinical research in Latin America has grown steadily in recent years. However, sponsors entering the region consider more than just patient volume. Study performance often depends on operational details that only become clear once a trial starts. These include the speed of approvals, the accuracy of enrollment assumptions and the consistency of communication among research teams as timelines tighten.
“i9 Pesquisas Clínicas works in the middle of those day-to-day pressures.”
Many delays occur before the first participant is enrolled. Start-up documents can take time to move between review bodies. Recruitment estimates may weaken as inclusion criteria become more specific. Communication gaps between sponsors, coordinators and investigators can lead to setbacks that affect later phases of a study. As a result, sponsors are paying closer attention to how research organizations manage execution at the site level.
Sponsors usually notice the difference early. Some research sites move studies forward efficiently once activation begins. Others spend weeks going back and forth on documentation, revisions and enrollment assumptions that were never realistic to begin with. A protocol can look solid during feasibility and still slow down later when patient availability turns out to be smaller than expected. Across Latin America, even minor differences in approval pathways or reporting requirements between countries can affect how quickly a study gets underway.
“Study performance often depends on operational details that only become clear once a trial starts.”
Recruitment adds another level of unpredictability. Fields like cardiology, pulmonology, endocrinology, gastroenterology and dermatology may seem to have large patient pools, but eligibility criteria have become much stricter. Sites cannot depend on outreach alone. Enrollment often relies on how well coordinators prescreen patients, how actively physicians engage and whether participants remain committed once the study starts. Research groups with established physician relationships usually find it easier to maintain steady enrollment because the referral process already fosters familiarity and trust.
Study complexity has also changed how sponsors assess research partners. Modern trials generate large amounts of clinical and safety data. Sponsors now expect this information to be documented accurately and reported promptly. Small reporting issues or protocol deviations can become bigger problems later if communication among coordinators, investigators and sponsors is not carefully managed from the beginning.
Brazil’s regulatory landscape has changed as well. Recent reforms aimed at reducing approval delays have made the country more attractive for global clinical programs. Research organizations that adapted early to these changes while keeping stable internal processes are now better positioned to support faster study activation without adding extra operational strain later in the trial.
i9 Pesquisas Clínicas works in the middle of those day-to-day pressures. Operating from Campinas, Brazil, the company supports Phase II, III and IV studies across several therapeutic areas. Its positioning appears to rest less on volume and more on execution discipline, including careful prescreening, continuity across study teams and a low-deviation operating model. A large part of that work comes down to coordination. Recruitment timelines need constant adjustment. Patients require follow-up. Sponsors, investigators and coordinators all need updates at different stages of the study, often simultaneously. i9’s long-tenured team structure is part of that reliability, helping studies move with less operational noise once recruitment and site activity begin. Its structure is built to keep those moving parts aligned while maintaining the reporting and documentation standards sponsors expect during active clinical programs.
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