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STRIVING FOR A HEALTHIER WORLD Your contract research organization

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Page 1: Your contract research organizationrapassarini.com.br/wp-content/uploads/2019/07/GRINN... · GRINN Clinical Trials Randomized clinical trials serve as the standard for clinical research

STRIVINGFOR A HEALTHIER

WORLD

Your contract research organization

Page 2: Your contract research organizationrapassarini.com.br/wp-content/uploads/2019/07/GRINN... · GRINN Clinical Trials Randomized clinical trials serve as the standard for clinical research

GRINN is a contract research organization (CRO) specialized in innovative study designs for Clinical Trials, Literature Reviews and Real World Evidence. We offer both full service and functional service provision solutions.

Our scientific expertise, exclusive focus on clinical studies, flexible and technology-based approach and strategic partnerships make us highly competitive in the clinical research market. We share your vision to drive healthcare forward.

MissionTo empower healthcare stakeholders by providing clinical information through innovative and upfront clinical studies designs, while contributing to a better informed and healthier society. At GRINN, we focus on continuous optimization and creative, results-driven ways to get things done and enable you to fast forward your clinical development.

Values World-class performance;Results driven;Innovative approaches;Customer commitment;Teamwork;Social contribution.

VisionTo deliver the top performance and to be the world's most admired clinical research company by its contribution to making healthcare decisions faster, clearer and fairer; and by its commitment with society.

About Us

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Public and private organizations including medical devices, biotech and pharmaceutical industries, startups, government, foundations, academia, and research groups and individual professionals; worldwide.

Our Clients

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FULL SERVICE

Our end-to-end solutions, from design to delivery, can significantly reduce timelines and lower costs helping you expand your development capabilities. Benefit from faster, more efficient clinical studies. Go over each section to learn more.

GRINN Clinical TrialsRandomized clinical trials serve as the standard for clinical research. We are prepared to help you design, simulate and execute your clinical trial. In addition to the traditional trial designs, we also offer options including:

Adaptive trialsAn adaptive design is a more flexible, efficient and fast trial design that allows for modifications to the trial and/or statistical procedures after its initiation. It uses partial trial results to modify the trial's course in accordance with pre-specified rules. It increases the efficiency of randomized clinical trials by enhancing the likelihood of finding a true benefit, if one exists, of the intervention being studied; and, ultimately, helping accelerate the discovery process.Virtual trialsVirtual trials allow for streamlined, convenient patient participation right from home or other preferred location, maximizing patient availability and enrollment in the study. It offers the opportunity for a more patient-centered approach to collect safety and efficacy data from trial participants. The need for multiple sites and multiple patient visits to the sites is eliminated leading to an increased number of trial participants and reduced costs. These trials make use of latest technologies and purpose-built processes to increase patient engagement and reduce risk in clinical development process. Pragmatic trialsPragmatic trials are designed to test the effectiveness of an intervention in real-life settings including the full spectrum of the population to whom the intervention will be applied. Patient eligibility criteria are less restricted and the results can be generalized and applied in routine clinical practice. These trials are complementary to the traditional explanatory trials, which measure efficacy instead of effectiveness.

Solutions

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GRINN Literature ReviewsOur literature review services include full and rapid systematic reviews with or without meta-analysis or metasummary. We use this type of study to gather data from the literature to analyze safety and efficacy of existing drugs or medical products. At the end of the study, we are able to classify the level of evidence of the target drug/medical product and say whether new studies are still needed to prove safety and efficacy and how exactly these studies should be. Besides the systematic reviews, we can also conduct simpler literature reviews as integrative reviews and scope reviews. Data from these studies can integrate regulatory clinical evaluation reports (CER), economic studies, among others; as it can be published in scientific journals and conferences.GRINN Real World EvidenceReal World Evidence (RWE) relates to evidence from real world data (RWD), i.e., data generated outside the context of a clinical study, as for example during routine clinical practice. Other sources of RWD include electronic health records (EHRs), claims and billing activities, product and diseases clinical registries, mobile health devices, etc. RWE has been increasingly used by regulatory agencies to monitor post market safety and adverse events and to support regulatory decisions of effectiveness. Our team has experience designing studies using RWD and also designing product and disease clinical registries in accordance with international standards.GRINN for startups!Program specifically for startups developing technologies for healthcare which need clinical data for product validation, testing and/or registration. We help you:

Generate clinical data for product registration, which can include literature reviews and/or studies designed specifically for your technology (it will depend on the type of product);Demonstrate the potential and clinical impact of your technology and help convince clients and investors.

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Solutions

Study DesignStudy Start-up and Close-outSites Selection and ManagementStudy Implementation ManagementRisk-Based MonitoringSite AuditingClinical Data ManagementMedical Writing

Clinical Investigational Plan (CIP)Investigator’s Brochure (IB)Clinical Study Report (CSR)Literature ReviewsScientific ManuscriptsResubmissions and Responses to ReviewersConference AbstractsClinical Evaluation Reports

Literature SearchesPublication Planning and Journal Submission SupportClinical Trials RegistrationSystematic Reviews Registration

FUNCTIONAL SERVICE PROVISION (FSP)

Our collaborative and strategic FSP solutions offer the possibility of outsourcing only part of your study. Some tasks in clinical research are very specialized, resource and time-consuming, thus you may want to outsource the execution of the service, while still maintaining control of your study. Hiring a FSP solution allows you to lower operational costs, improve quality, mitigate risk, gain services with a relevant expertise, while you can focus on your core business. Check our FSP service options below.

TRAINING

Our training solutions cover a diverse range of clinical research topics and are totally customized to the need of our clients. Whether your company is in need of a general training for a large group of employees or a very customized training for a few people, we can design a specific program to help you achieve your objectives. In addition to our in-company customized training programs, we also offer, from time to time, some open enrollment courses by ourselves or in partnership with other companies/universities. Get in touch to know more about our training options.

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Contact: [email protected] Phone / Whatsapp: +55 51 99947-4276Website: www.grinn.co Follow us on: /grinncompany /company/grinncompany