What we do
The clinical research conduction involves several fundamental steps, starting with a good research question and ending with the article publication. What is the best study design? How many patients are needed? How to conduct the data analysis? How to report the results and insert them in the appropriate context? Academic leadership involves the protocol design and manuscripts writing by professionals with different expertises such as: trialists, statisticians and clinicians.
The HCor Research Institute acts in all clinical research steps, with a team of professionals (medical trialists and statisticians) with extensive expertise in leading clinical trials and other research designs, including observational studies, systematic reviews (with or without data meta-analysis) and cost-effectiveness analysis. The HCor Research Institute has published studies in high impact journals, such as JAMA, BMJ, Circulation, Intensive Care Medicine, among others. We provide individualized support and execute each one of the steps on demand, from research protocol design to manuscript writing.
REGULATORY AFFAIRS MANAGEMENT
The Regulatory Affairs Management is an important part of the organizational structure of the HCor Research Institute and works on the interface among the institute, the national and international regulatory authorities and the research sites.
The Regulatory Affairs Department is composed by a multidisciplinary and multi professional team and has as primary responsibility the regulatory dossier elaboration and submission to several instances, the documents compilation, and the assistance to included sites and support to institutional researches.
The area professionals aim to receive the appropriate regulatory approvals for clinical trials conduction, as soon as possible, in accordance with the current National and International Legislation, in order to guarantee the studies legal compliance, as well as to ensure the quality standard of the studies that are developed at the HCor Research Institute.
The provided services are:
- Study Start Up:
- Elaboration of documents for appropriate ethical evaluation
- Regulatory agencies submission
- Pending issues control
- Submission of coordinator site notifications and partial reports
- Participant Sites Start Up:
- Invitation to participate in the study
- Assistance throughout regulatory process up to site approval
- Assistance throughout study conduction in issues pertinent to the department
- Interface with the participant site for minute analysis up to signatures finalization
- Institutional Support:
- Assistance with regulatory documentation of external researches
- Quality Control:
- Indicators verification of regulatory steps and punctual analysis of critical issues during the project conduction
- Study Start Up:
It regards the study management from the protocol planning phase to the results publication. In this sense, this activity requires much more than technical scientific knowledge about the studied topic, being essential for the conduction and research success.
The HCor Research Institute site management team is composed by experienced and qualified professionals with expertise in clinical research and scientific methodology allowing adequate planning and efficient conduction of the study.
We use project management tools and techniques to ensure that the study is conducted in an effective manner, in accordance with the established deadlines and budgets, and in compliance with the study protocol and good clinical practice guidelines.
Our activities contemplate site selection, investigational product logistics organization, manual of operations elaboration, on-site or remote monitoring visits, elaboration and maintenance of strategies to ensure patients recruitment and adherence, investigators meeting among other activities.
Clinical trials generate a huge amount of information. Increasingly, the changes in clinical practice are based on high quality and complex scientific information. Therefore, the clinical research data management is essential to maintain the data accuracy and integrity and consequently, to promote valuable and reliable knowledge.
Our team has professionals from several areas what allows us to seek solutions for the most diverse problems within clinical research in addition to scientific expertise and experience in national and international trials conduction.
Our activities are in accordance with the highest quality standards and scientific innovation. The HCor Research Institute continuously invests in new technologies and tools to improve the data management. Our activities include from data management plan development and e-CRFs to the complete resolution of inconsistent data.
The HCor Research Institute statistical group acts from the study planning to the statistical analysis of the databases for scientific production. In long term studies, a well developed design is fundamental. Our statisticians’ team has extensive expertise in planning and analysing randomized clinical trials; including cluster randomized trials and factorial studies, observational studies and in advanced methods in meta-analysis. Currently the analyses are performed with R free software.
At the HCor Research Institute there is a huge involvement of the statisticians with the researchers in several steps: sample planning, development and publication of the statistical analysis plan, data management with quality statistical check, interim analysis for data monitoring committees, data analysis for final reports and manuscripts.
SYSTEMATIC REVIEWS AND HEALTH TECHNOLOGIES ASSESSMENT
Systematic review is a summary of evidences from primary studies conducted to answer a specific research question. It uses a process of comprehensive, unbiased and reproducible literature review that finds, evaluates and summarizes the evidences pool of scientific studies to obtain an overview of the effect of and intervention. Meta-analysis is a statistical analysis that combines the results of two or more independent studies, generating one single effect estimate.
The huge volume of scientific publications available in the biomedical area makes it impossible to obtain knowledge through the individual reading of the publications. The aim of the systematic review is to summarize the entire available information about one research question in a systematic and unbiased manner, while the meta-analysis considers the number of participants in the studies included in the systematic review, allowing evaluating the effect of a treatment or some exposure more accurately. Thus, the systematic review allows the reader a quick and efficient update to support the decision making, being him the health manager or the clinician.
Our Health Technologies Evaluation Center conducts systematic reviews in several therapeutic areas, in addition to the ones focused on risk, prognosis, incidence and prevalence of diseases, following the highest methodological quality standards. We also offer courses to train people to conduct their own systematic reviews.
Our researchers have extensive experience in the conduction and publication of systematic reviews in high impact factor journals. Ours courses are imminently practical, allowing students to experience all steps and be able to conduct their own systematic reviews.
To estimate health efficiency in uncertainty scenarios is fundamental to put products in adequate position in the marketing. Recently, the ability to estimate the return that products can give to society segments has also gained regulatory importance; exercise that, sometimes, it is indispensable for drugs register, for example, and to modify use recommendations in clinical protocols. The researchers need, therefore, to understand how the most diverse products can bring health return health for their consumers.
The HCor-RI has expertise that helps researchers to build their efficiency estimates for their products, mainly with cost-effectiveness studies. We work in partnership to build analytical models that help to elucidate the products efficiency in a highly competitive market.
CLINICAL EVENTS ADJUDICATION
Clinical research IS conducted to obtain answers that change clinical practice. In this manner, the interventions assessed in large clinical trials usually aim to reduce the burden of important clinical events (e.g.: myocardial infarction). There is evidence that different sites and investigators can classify events differently. The lack of criterion in these outcomes definition may interfere on the study results leading to doubts in the use of this evidence in clinical practice. Based on this, the major regulatory agencies require that all potential clinical events identified in clinical trials be validated and classified by a group of independent reviewers that use the same criterion in a standardized manner.
We are a Brazilian team with experience in adjudication for important international research centers as PHRI and DCRI. In addition, we are a team composed by doctors of different specialties with huge clinical experience and who use the updated definitions for diseases’ classification.
DATA MONITORING COMITTEE
In some instances data obtained from clinical trials need to be monitored and assessed by an independent group during trial conduction. The HCor Research Institute also acts in the planning and management of the Data Monitoring Committee, assessing the clinical trial conduction. The Data Monitoring Committee acts recommending the study continuation or termination after interim analyses according to pre-specified stopping rules.
Regardless of the type of intervention, the HCor Research Institute has experience in monitoring the most diverse types of study, providing realistic and statistically accurate interpretations during the interim analysis always in an efficient and impartial manner.
To develop large clinical trials, acting as an ARO, is the fundamental activity of the HCor Research Institute.