Clinical Research Division
About the Institute
The Institute is a Brazilian nonprofit academic research and development institution to search for treatment and quality of life options for people with rare diseases and to address some barriers to implementing pharmacogenetic tests into clinical practices. The initial focus was on Rare Diseases, Amyotrophic Lateral Sclerosis (ALS) and Cancer.
H2CI Alagoas is consolidating its other Precision Public Health research, data management, advanced medical devices, regulatory affairs, logistics (Manaus Free Trade Zone for importing/exporting), medical writing, clinical trial services, and project management activities under the Institute Brand and elevating it to full Clinical Research Organization (CRO) status.
We hope to begin construction of our new Center of Excellence in Maceio in 2025.
The Institute operates as the main contact between sponsors and other stakeholders.
As the CRO, we communicate with ethics and compliance committees, regulators, vendors, physicians, and research coordinators.
What We Do
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Clinical Research and Clinical Trials
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Patient Advocacy for Clinical Trial Registry
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Tropical and Rare Disease Research & Development
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Inherited and Mitochondrial Disease
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Combining Precision Medicine Expertise Across Borders
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Pharmacological Innovation (Pgx)
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Pharmacodynamics
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Digital health solutions for Amyotrophic Lateral Sclerosis
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Accelerating Personalised Oncology into Clinical Practice
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Precision Medicine
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Early cancer diagnosis using Ion-mobility Spectrometry coupled with our AI software
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Digital health solutions advancing Capsule Endoscopy
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Artificial Intelligence Algorithms for the implementation of large-scale routine medical Diagnostics and Imagery Analysis
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Genomics for Precision Public Health
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Smartphone-based Quantitative molecular detection platform
“smart connected pathogen tracers"(SCPT) -
Genes and their Mutations
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microRNA as Predictive Biomarkers
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Polyamines and Ion Mobility Spectrometry
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Education & Conferences
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Integrated Community Care
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Social Programs
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Our FocusThe consolidated Institute’s research activities will continue to focus on Inherited, Tropical & Rare Diseases; the development of gene therapies and genome editing strategies; Pharmacological Innovation (Pgx); Cancer; Breath Biopsy and Biomarkers; advanced medical screening technologies and methods, as well as Clinical Trial Sponsorship. Educating and enabling practical experience for student Medical Doctors, Clinicians, and Technologists is fundamental to our activities. We promote education and scientific dissemination actions across different types of audiences, reaching broad sectors of local and international society in conjunction with our experts, strategic partners and institutions. Our facilities provide a unique experience for students and professors from different academic universities and institutes the ability to work collaboratively on a unified project and then extend this research into the community with our mobile clinics and rural track programs. We facilitate the mandatory 120 hours of face-to-face dialogues with individuals in rural and metropolitan areas to improve Public Health and provide the students with practical experience via our collaboration with the SUS Mias Medicos (rural and metropolitan) and Macieo's Brota na Grata initiatives. The data collected is used to influence policymaking and improve SUS healthcare systems that experience higher incidences of diseases, barriers to transportation and access to care in a predominance of low-income households. We also sponsor medical procedures, provision of advanced personalized medical technologies, and innovation transfers via seminars developed by our 80+ international consortium members and from their National projects we will transfer to Brazil. We provide BOLSA's , international student exchanges, and support for Masters, PhD, and Post-Doctoral candidates.
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Global ReachIncorporating H2CI’s extensive European Union and global collaboration partners and projects across 80 countries, we will continue to advance the state of the art for Cross-Border Clinical Trials, AI-assisted diagnosis, innovative gene therapy (ATP) as well as, Personal Care Records, integrated Clinical PGx, Hospital or UTI@Home Personalized Medicine; Medical Software Applications; Professional Education & Conferences; Integrated Community Care and Social Programs.
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AI-Assisted Diagnosis and Recommended ActionsSome of our more advanced medical projects and applications for genomics and precision public health incorporate the power of Artificial Intelligence to assist medical professionals with a risk-based approach to diagnosis. This complements their professional skills and experiences. They help reduce costs without sacrificing assurance of data reliability, investigator compliance, or meeting regulatory reporting obligations.
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Achieving Regulatory ComplianceOur Regulatory Affairs activities include coordinating with Research Ethics Committees, medical device approval authorities at country levels with Brazilian- ANVISA, the European Medicines Agency (EMA), and US Food and Drug Administration (FDA). We can help you design a clinical study tailored to your product’s specific needs and collect data efficiently while qualifying actions under the Medical Device Single Audit Program (MDSAP) regulatory requirements.
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Proven Project DeliveryClinical project management is important to ensure that your trial runs as smoothly as possible. Our clinical project management team has decades of experience managing trials. We emphasize efficiency in conducting clinical trials while maintaining exemplary quality and compliance. Our team can complete clinical site assessments, help you prepare documentation for Ethics Committees, complete the site initiation and training, and complete the necessary steps for trial closeout. Our experience across a multitude of trial sites around the world has taught us how to evaluate potential sites, and the right questions to ask to determine the best fit for each clinical trial. Smart site selection contributes greatly to completing a clinical trial on time and on budget.
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Study Protocol Development for the Introduction of New ProductsOur protocol development process involves working in collaboration with clinical experts and other study stakeholders to identify reasonable performance goals, determine appropriate examinations and procedures, and define the right patient population. This ensures the clinical study protocol will successfully implement the study plan and maintain compliance with all applicable regulatory requirements. A well-written protocol is essential to maximizing efficiency and minimizing risks in gathering the necessary clinical data for your product. We can create case report forms (CRFs) that comply with the Brazilian Registry of Clinical Trials (ReBEC), the Pan American Health Organization (OPAS), and the World Health Organization Good Clinical Practice (GCP) ICH E6(R3) standards. Our CRFs are customized to suit the project type and individual requirements using AI Assisted Automated Clinical Trial Eligibility, Surveillance, Dash-boarding and Reporting. Active clinical monitoring can help predict potential clinical trial challenges or at least identify issues early so they may be addressed before they lead to significant delays leading to increased costs, or derail the trial completely.
Specialized Research
Inherited, Rare & Tropical Diseases-13 million people in Brazil have a genetic rare disease--80% do not have identified treatments
Personalized Pharmacogenetics PGx genotyping
Long-read Sequencing-CYP2D6
Integrating PGx into ongoing cancer genetics projects
Brain-computer interfaces
Boosting Research & Development
Our service offerings can improve your productivity through intuitive, connected solutions that accelerate processes, minimize staff turnover and reduce costs.
Data Rich Clinical Trials - developing digital systems (information-technology solutions) facilitating data; using more efficient, adaptive clinical trial methodologies; and
increasing patient engagement with Clinical Trials.
Personalized Patient Experiences
Improving the patient experience and satisfaction with personalized sharable medical details, appointment reminders, and online consultations.
iParticipate and iConfirm- smartphone based user applications that allow patients to learn about clinical trials, enrol to participate, consent to their data usage, and provide contunous feedback to both researchers and for the well-being of the participant.
Ensuring Data Privacy & Compliance
Only authorized personnel with the appropriate privacy and confidentiality training and authorized third parties will be able to access the identifiable personal information you provide. We typically create de-identified data from the personal information you provide by excluding information that personally identifies you and use this de-identified data for research and product development, or any other legal purpose.
We will not sell the personal information you provide to any third party. We may share personal information with our affiliates, third parties, and research partners acting on behalf of the Institute. The information you provide may be used to determine your potential eligibility for current and/or future clinical trials as well as for research purposes and potential product development. If required, we may also share information you provide with regulatory agencies, such as an institutional review board (IRB), to comply with our regulatory obligations or to comply with the law.
AI-Assisted Clinical Trials
Apps and Portals to improve Trial participation, outcomes, reporting and data sharing. We are dedicated to providing high-quality clinical data management services to support your product needs, obtaining clinical trial data you can trust, saving time and resources.
AI-Assisted Dash-boarding
Our medical applications are designed with decision-making aids and are specially developed for early detection of diseases typically not detected in conventional examinations. AI algorithms provide early detection of the underlying issues, crucial for rapid analysis with recommendations to the doctor for actions.
Our Clinical Trial apps provide real-time visibility and insight into project proceedings-- highlighting potential issues with risk mitigation suggestions.
Scalability On-Demand
The C in our name stands for Consortium. It was first established in 2015 and has grown to have partners across 80 countries to help us achieve our strategic objectives. The Consortium has universities, research centres, NGOs, and SMEs operating under joint venture, multi-territory enterprise, or special purpose entity instruments. Each member of H2CI was specifically chosen for their potential to strengthen our global position in research, innovation, and technology. We work in partnership with our clients and look at their problems holistically.
Our consortium provides world-class business leaders, scientists, engineers, researchers, technologists and healthcare professionals that are committed to the development of breakthrough solutions to today´s and tomorrow's concerns.