In clinical research, ensuring that a participant meets eligibility criteria and is not enrolled in multiple studies simultaneously (co-enrollment) is critical to ensuring scientific validity,
Introduction Early-phase clinical research centers face unique challenges: complex protocol designs, tight timelines, high data quality expectations, and increased regulatory scrutiny. Sites still relying on
On April 22nd, we celebrated Earth Day, which calls for action, environmental awareness, and the transformation of our habits. But beyond the symbolic messages, this
Clinical trials have always required informed consent, guaranteeing that participants are fully aware of the study’s goals, methods, and risks. However, conventional, lengthy consent forms
Monitoring visits are indispensable in clinical research to guarantee data integrity, mitigate protocol deviations, and ensure regulatory compliance. Clinical Research Associates (CRAs) carry out these
“In vaccine clinical trials, missing safety data in daily collection creates challenges in reporting safety outcomes to the agencies”. This was one of the key
In vaccine clinical trials, tracking participant safety is non-negotiable. Unlike drug trials, vaccine clinical trials involve healthy volunteers, making real-time monitoring of adverse events (AEs)
Patient adherence and data accuracy are non-negotiable in vaccine clinical studies. Inadequate reporting can jeopardize regulatory submissions, raise expenses, and postpone the conclusion of studies.
Table of Contents Introduction Regulatory compliance in clinical trials is a cornerstone for ensuring participant safety, data quality, and scientific validity. For many organizations, achieving
Table of Contents In clinical research, centers face numerous challenges in managing processes, data, and regulations. An ERP-CRM solution like Trial 360, based on the
Table of Contents Are you tired of using tons of paper to manage your clinical trials? You’re not alone. Clinical trials are complex, and
Table of Contents “Utilizing ePROs not only facilitates better data collection but also contributes to improved quality of care and patient safety”. “FIdec achieved over
Table of Contents Effective clinical trial management is critical to success in drug development. A clinical trial management system (CTMS) is an essential tool that
Table of Contents Adherence to Good Clinical Practices (GCPs) is mandatory in clinical trials. These rigorous standards ensure safety, ethics, and reliability in medical research.
Table of Contents Utilizing CTMS can cut operational costs by about 25%, making clinical trials more cost-effective. This significant reduction in expenses allows research centers
Table of Contents For many research centers or networks, traditional methods such as paper documentation and non-integrated systems have become major bottlenecks, slowing down processes
Table of Contents Why are patient recruitment and retention important for clinical trials? A clinical study’s purpose is to answer a research question. To do
Table of Contents When developing new vaccines, patient safety is paramount. Phase I vaccine trials determine safety and efficacy before public release. Data collection is
Table of Contents Despite its critical nature, decision-making in research centers often relies on traditional methods, leading to inefficiencies and errors. This blog discusses how
Table of Contents Since 2010, regulatory bodies globally have expressed interest or provided written guidance on their expectations regarding the electronic source document (eSource). What
Cancer is a leading cause of death in Latin America, with the region experiencing an alarming rise in cases. It is projected that by 2040,
New medical treatments haven’t reached everyone equally. Why? A lack of diversity in clinical trials. African Americans make up 13% of the US population but
Artificial intelligence (AI) and machine learning (ML) herald a new era of regulatory operations in clinical trials. These advanced technologies are revolutionizing how companies manage
Clinical trial participation is the core of future medical advances. But for sites, recruiting patients in clinical trials and conducting them on the journey is
From the ideation of the scientific question, sponsors can consider integrating ePRO tools in protocol designs. Decentralized and hybrid clinical trials can widen the data
Table of Contents What is eConsent and How Does it Improve Clinical Trials? We all recognize the vital role informed consent plays in clinical trials.
Daily site operations and visit scheduling are often a burden for clinical research teams, who constantly seek to engage and build long-term relationships with participants.
What is electronic patient-reported outcomes (ePRO)? ePRO stands for “Electronic Patient-Reported Outcomes.” It is a tool that allows patients to record electronically and submit their
Table of Contents The global eCOA market is poised for significant growth in the coming years. Grand View Research shows the market is expected to
How is the billing of clinical protocols in Trial360? In the world of clinical research studies, a key focus is on precision, compliance with regulations,
Welcome to the forefront of efficiency in research protocols execution! Protocol research centers struggle with balancing quality and affordability. Trial360 emerges as a beacon
To establish confidence in the results of clinical research, quality control in the execution of the protocol is an essential pillar. Quality control must guarantee
Poor patient reporting adherence can prolong the trial duration by increasing the time required to gather complete and accurate data. This can extend the overall
Clinical research protocols are carried out following the International Council for Harmonization (ICH) guidance on Good Clinical Practice (GCP), which outlines the requirements for corrective
In the 21 CFR Part 11, the FDA established guidelines for electronic records and electronic signatures. A fundamental aspect of compliance in clinical trials is
Remote monitoring of clinical trials in Trial 360: Innovation for a More Efficient and Safe Future Clinical trials are vital in developing and approving new
Research sites face a critical challenge that has an effect on their sustainability and overall performance: invoicing and financial management. It is common for sites
Scheduling at research sites is not as straightforward as in other clinical services. Commonly, patient visits must be scheduled according to a research protocol and
Delegation Log in Clinical Trials Trial360 delegation log is a vital tool for research sites. It serves several crucial purposes, ensuring compliance, accountability, and efficient
Around this season, many research sites are planning and projecting their budget for the upcoming year 2024; this is an excellent opportunity to consider a
Trial360 new enhanced PI – QA – Data entry Oversight Feature The new and improved quality review functionality within Trial360 seamlessly integrates quality assessments directly
We chose Odoo business suite (ERP, CRM, etc) as the foundation for Trial 360 because it offers the robustness, security, flexibility, experience, and scalability that
Recently, we participated in the global meeting of research centers of the Society for Clinical Research Sites – SCRS in Hollywood – Florida. Today, we
At Integra IT we have identified the great opportunity for research sites of beeing visible in the digital environment. The sites can gain competitiveness,
Clinical trials are essential to advancing medical science and providing patients with novel treatments. The optimization of clinical trial operations depends critically on effective data
Electronic Clinical Outcome Assessments (eCOA) and Electronic Patient Reported Outcomes (ePRO) are two types of electronic data collection methods. While they may seem similar, there
As the demand for efficient and streamlined data management in clinical trials continues to grow, with numerous vendors offering a wide range of features and
Integra IT has developed reliable eCRF software solution and Data management services priced to fit your budget and excels in delivery, quality, support, and time.
An FDA 2020 report (1) has shown a 28% decrease in underrepresented populations in United States clinical trials compared to 2018. Moreover, the 2022 FDA
Last week we joined the Clinical Research Insider Summit in Cancun, Mexico. This was Integra It’s first time participating in this event, endorsed by the
Recently, we started a new polio vaccine clinical trial in the Dominican Republic with FIDEC (Fighting Infectious Diseases in Emerging Countries). This initiative is close
Vaccine clinical trials are very complex, around 12 years are needed between Phase I and Phase III studies until a license can be achieved, and
In recent years, sites have increasingly invested in technology to eliminate paper records and reduce workloads related to inputting data, scanning, and transcription. Even though
Investigator-Initiated Studies (IIS) are studies where an individual investigator, a research site, or a group of research sites carry out the research from the protocol
ePRO/eCOA Capabilities to better conduct Clinical Studies ePRO/eCOA tools have revolutionized the clinical research industry. The first concept was raised a decade ago, but the
Cybersecurity: Critical in Clínical Trials In recent years, the number of cyberattacks has increased due to the proliferation of viruses, malware, and new and
Computer System Validation is a premise for Integra IT to ensure that data and solutions are reliable; validating all of our solutions is one of
Integra IT understands and has the solution to an issue commonly faced by healthcare systems and clinical trials around the world: interoperability. Seamless integration between
An efficient clinical trial of the polio vaccine was critical for the emergency approval of the sponsor vaccine against the second wild strain. Then, solve
According to the American Agency for Healthcare Research and Quality (AHRQ), Electronic Medical Records EMR system is defined as “an electronic record of health-related information
Cevaxin, a research Site located in Panama, used TrialPal to achieve an outstanding eDiary reporting compliance rate in a Phase I vaccine clinical trial with
COVID-19 studies in healthcare workers in University of Mainz Integra IT had the opportunity to participate and contribute with its tools in observational COVID-19 studies
Integra IT software solutions has been essential for developing the Fiocruz vaccine Phase 3 trial for SARS-CoV-2 in Brazil, achieving efficiency in data collection and
The decentralized model proposes the performance of clinical trials as partially or entirely remote. The main activities of the trial can be driven through technology
Data move us! Our eCRF & Data Management Services gives clinical trials a broad and precise operations control under one integrated platform. We have vast
Looking for more efficient clinical trials? Inspired by a real site network, our Trial 360 solution is a complete Enterprise Resource Planning (ERP) that works
Cevaxin is a sites network in Panama, their Clinical Trials Digital Management are carried out in cities such as La Chorrera y David and the
Peru, a country of nearly 33 million people, was hit by the COVID-19 coronavirus pandemic mainly because the health system, like that of many other
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