Alternatives to FICS

H1 Universe is an innovative platform that leverages artificial intelligence to enhance the management of healthcare data, offering users access to the most extensive global database of healthcare providers (HCPs). By merging information from various sources, such as public, private, and proprietary databases, H1 Universe provides valuable insights that are crucial for clinical trials, medical affairs, and commercialization efforts. This powerful tool enables healthcare teams to pinpoint essential stakeholders, refine clinical research processes, and make informed decisions swiftly, ultimately boosting overall efficiency within the healthcare landscape. Furthermore, the platform not only aids in real-time decision-making but also fosters collaboration among healthcare professionals, paving the way for improved patient outcomes.

Castor offers an intuitive and comprehensive platform for managing clinical trial data, focusing on electronic data capture (EDC), eConsent, and patient-reported outcomes (ePRO). The platform is optimized for decentralized trials, providing seamless tools for remote patient engagement and data collection. With real-time reporting, Castor helps researchers track trial progress and make data-driven decisions. The solution ensures compliance with industry regulations such as HIPAA, GDPR, and 21 CFR Part 11, making it ideal for life sciences organizations looking to enhance trial efficiency while maintaining high data integrity.

Numerous organizations globally rely on IQVIA to accelerate the drug development process, guarantee the safety and quality of products, enhance commercial efficacy, deliver appropriate treatments to patients, and ultimately promote improved health outcomes by facilitating access to and delivery of healthcare. Transform your approach to clinical development by seamlessly integrating data, technology, and analytics to streamline your trials. The outcome? Quicker decision-making and minimized risks, enabling you to provide transformative therapies at a faster pace. With its expertise rooted in data, sophisticated analytics, and deep industry knowledge, IQVIA offers tailored capabilities to clients throughout the healthcare landscape. Stay informed by exploring the latest insights and updates from IQVIA's data scientists, healthcare professionals, researchers, and other industry experts on crucial topics that resonate with your interests. From emerging industry developments to practical applications of our capabilities, a wealth of information awaits you here. Engaging with this content also empowers you to stay ahead in a rapidly evolving healthcare environment.

At Komodo Health, we integrate an extensive understanding of patient interactions with cutting-edge algorithms and years of clinical knowledge to create our Healthcare Map, which offers the most accurate representation of the U.S. healthcare landscape. This Healthcare Map serves as the backbone for our comprehensive suite of software solutions, designed to help you provide exceptional value to your customers, colleagues, and patients alike. Relying solely on traditional scholarly data for strategic planning is now outdated. Our Aperture platform has been meticulously crafted to deliver unparalleled insights into clinical leadership and influence, enabling improvements in care standards where they are needed most—whether that involves the most referenced author, a prominent social media influencer, or the physician with the highest patient volume. Moreover, conventional open/sampled prescription and patient-level data often overlook critical patterns that are essential for accurately identifying individuals with complex care needs or uncommon medical conditions. By addressing these gaps, we aim to enhance patient outcomes and streamline healthcare delivery.

Historically, clinical trials and medical research operated separately from the routine care provided in local healthcare facilities and by individual doctors. Many physicians remained unaware of ongoing research initiatives, leaving patients largely uninformed about studies that could enhance their treatment outcomes or health. Elligo has transformed this landscape by facilitating unprecedented participation in clinical research through access to a vast network of over 150 million patients and their comprehensive data, enabling doctors to present research opportunities to patients who might not otherwise encounter them. Traditional methods of recruiting participants often face challenges, such as the need for patients to travel to specific research sites, which can limit involvement. Moreover, studies indicate that patients are more inclined to participate in research when it is associated with their trusted healthcare provider, underscoring the importance of integrating clinical research into familiar medical environments. This approach not only bridges the gap between research and patient care but also empowers individuals to take part in potentially life-changing medical advancements.

A cloud platform that is accessible from anywhere, infinitely scalable, and powered by AI offers collaborative features while adhering to the strictest security and compliance standards. This user-friendly software, designed by specialists in neuroimaging and data science, addresses the specific and complex requirements of the neuroscience field. Customized to suit your particular needs, it supports a wide range of activities, including research, clinical trials, point-of-care applications, algorithm development, and the utilization of brain-related data. The platform facilitates global data aggregation and consolidates imaging studies into a single cloud environment. It provides an efficient, comprehensive management solution for clinical, real-world data, and medical imaging information. Users receive tailored, expert assistance throughout their studies to ensure successful outcomes. Additionally, it features centralized reading capabilities and the option to compare quantitative results against a normative database. The platform also guarantees high-quality, shareable reporting and data export options to streamline the submission approval process, making it an invaluable tool for neuroscience professionals. Furthermore, its innovative design enhances collaboration among researchers and clinicians, fostering a community dedicated to advancing the field.

Koneksa stands out as a prominent digital biomarker firm catering to the pharmaceutical and biotechnology sectors, focusing on the creation, testing, and validation of digital biomarkers that assist clients in assessing how treatments affect patients. Established in 2013, Koneksa delivers comprehensive remote clinical trial support by integrating digital health technologies, therapeutic knowledge, and swift, user-friendly remote data gathering to enhance understanding of patient health outcomes. Their innovative and validated data algorithms are designed for immediate use in treatment development initiatives, facilitating the detection of signals more rapidly than conventional methods. The company's cloud-based Software as a Service (SaaS) platform enables real-time integration of multiple endpoints, providing instant access to data and supporting informed, cost-effective decision-making early in the trial process. Additionally, this platform’s capability to gather extensive remote data at higher frequencies presents opportunities for obtaining ecologically valid measures, which can lead to a reduction in sample size while maintaining the integrity of the research. By continuously evolving their tools and methodologies, Koneksa aims to redefine how clinical trials are conducted in the modern age.

The TCS ADD platform significantly enhances the speed at which pharmaceutical companies can bring products to market by streamlining the entire clinical research and development process, ultimately leading to more agile and secure clinical trials. By fostering digital ecosystems and simplifying the intricacies of data management, TCS ADD facilitates quicker access to innovative and effective medications for patients. This platform utilizes the TCS Decision FabricTM, an advanced cognitive artificial intelligence engine, alongside smart analytics and the Internet of Things, delivering exceptional business advantages to the pharmaceutical sector. It serves as a comprehensive, metadata-driven solution designed to uphold industry standards and sponsor requirements in clinical trials. Furthermore, this data science-oriented platform employs artificial intelligence and machine learning technologies to expedite decision-making, accelerate study initiation, and implement targeted interventions. By digitizing the entire supply chain management of clinical trials while prioritizing patient safety, this solution not only improves overall effectiveness but also enhances the patient experience throughout the trial process. Ultimately, TCS ADD represents a transformative approach to clinical trial management that aligns with the evolving needs of healthcare.

Jeeva's patent-pending modular system is built on the most powerful cloud platform. One login from any browser-enabled device can be used to remotely screen patients, educate, enroll, send SMS, email and generate evidence including electronic patient-reported outcomes. They are tired of waiting for patient recruitment and retention to happen. It is crucial to provide sufficient evidence of safety and efficacy for investigational new medicines in order to receive regulatory agency approval. Jeeva is a great tool for saving time and money for patients, biopharma sponsors, and long-term follow up studies for gene therapy.

Progressing artificial intelligence to remove the need for trial and error in healthcare, our digital twins facilitate swift and assured clinical trials. We focus on areas such as neuroscience, immunology, and metabolic diseases, among others. TwinRCTs expedite full enrollment by requiring fewer participants to provide equivalent statistical power compared to conventional trial methodologies. This approach significantly reduces the time needed for late-stage study enrollment. Additionally, TwinRCTs enhance the ability to detect treatment effects in early-stage studies by bolstering statistical power without necessitating an increase in participant numbers. They enable researchers to make informed decisions based on initial study outcomes and help attract more participants to trials. By utilizing smaller control groups, TwinRCTs also improve participants' odds of receiving the experimental treatment. Our commitment to positioning clinical trials with digital twins for regulatory success is unwavering. Unlearn is at the forefront of transforming the medical field through the innovative application of artificial intelligence, creating and implementing novel generative models that are trained on vast datasets derived from previous patient studies. This evolution in methodology not only streamlines research but also enhances the overall effectiveness of clinical trials.

The Medidata Clinical Cloud represents our innovative platform designed to revolutionize the clinical trial journey for patients, sponsors, CROs, and research institutions. As the sole comprehensive technology solution focused exclusively on clinical research, the Medidata Clinical Cloud addresses the entire research spectrum from inception to completion. Our platform enables organizations in the life sciences and medical device sectors to reduce development expenses, manage risks effectively, and expedite the introduction of treatments and devices to the marketplace. Whatever selection you make for your clinical trial initiatives, you will benefit from the capabilities of the Medidata Clinical Cloud. At Medidata, we are at the forefront of the digital evolution in clinical research. With the power of artificial intelligence, machine learning, and sophisticated analytics, our platform connects researchers, study coordinators, investigators, and patients, thereby hastening the research process. Additionally, it provides a regulatory-compliant, patient-friendly electronic informed consent solution for clinical trials, ensuring a smoother experience for all parties involved. This integration of advanced technology not only streamlines operations but also enhances the overall quality of clinical research.

Deep 6 AI revolutionizes the patient enrollment process for clinical trials by changing how researchers pinpoint suitable candidates. By leveraging artificial intelligence and natural language processing, DEEP 6 AI efficiently sifts through both structured and unstructured patient information, enabling the identification of a larger pool of well-matched trial participants in mere minutes instead of the months typically required. The platform collaborates with leading health systems, pharmaceutical companies, and contract research organizations, positioning itself as an essential component of the clinical research ecosystem and significantly hastening the process for patients to access trials. In addition to expediting enrollment, Deep 6 AI’s innovative software evaluates structured data, like ICD-10 codes, alongside unstructured clinical information such as physician notes, pathology reports, and surgical documents that are often difficult to search through. This comprehensive analysis ensures that researchers can quickly find candidates who meet specific criteria, ultimately leading to faster delivery of groundbreaking treatments to those in need.

Enhance the quality of your evidence with superior electronic Patient-Reported Outcomes (ePRO) and electronic Clinical Reported Outcomes (eClinRO). These Electronic Clinical Outcome Assessments, known as eCOA, evaluate patients' feelings and functionality during clinical trials effectively. By collecting clinical data in an electronic format, you can ensure that the data from your patients is not only high-quality but also in compliance with regulatory standards. In essence, eCOA eliminates the challenges related to paper diaries, such as issues with readability, transcription mistakes, and discrepancies in data. Furthermore, the FDA advocates for the use of ePRO. This involves patients providing insights into their health through various questionnaires or assessments, which may include evaluations of quality of life or activity levels. Clinician-reported outcomes, on the other hand, involve health assessments made by a clinician, with examples such as physical examinations like PASI. Additionally, performance outcomes gauge a patient's ability to complete specific tasks, such as performing a timed activity, thereby offering a comprehensive view of their health status. Ultimately, the transition to eCOA and its associated methods signifies a move towards more reliable and efficient clinical trial processes.

Cloudbyz CTMS is a cloud-based trial management platform natively built on Salesforce Cloud. It is aimed at sponsors, clinical research organizations (CRO), and clinical sites for managing end-to-end clinical trial operations. Designed for clinical research, it expedites implementation and drives user adoption. Cloudbyz CTMS comes with an intuitive, straightforward design that allows for quick deployment. Boasting a rich set of features, Cloudbyz CTMS makes it easy for users to manage all aspects of clinical trials, including sites, enrolment, documents, events, milestones, site visit reports, finances, inventory, etc. The solution benefits are listed below- 1. Secure, reliable & scalable 2. Faster time to value 3. Monitor study progress & risks from planning to close-out 4. Seamless collaboration among sponsors, CROs & sites 5. Improved clinical team efficiency

Clin'form is an adaptable and powerful electronic Clinical Outcome Assessment (eCOA) platform that aims to simplify clinical trials for both patients and research sites, improve data integrity, and speed up processes for research teams. Its versatility allows it to be used across various protocols and demographics, making it suitable for any type of questionnaire—including Patient-Reported Outcomes (PRO), Observer-Reported Outcomes (ObsRO), Clinician-Reported Outcomes (ClinRO), and diaries—while catering to individuals of all ages, from children to the elderly. The platform is designed to handle diverse population sizes, effectively managing studies that involve anywhere from a small group to over 10,000 participants spread across multiple regions worldwide. Clin'form integrates smoothly with other clinical systems to provide an efficient workflow, supporting various data collection methods such as dedicated tablets or smartphones, the patient's personal device, web access on any browser, and in-person interviews. Noteworthy features include an integrated tele-visit option to accommodate unexpected changes and patient engagement tools that promote high levels of compliance. Additionally, Clin'form's user-friendly interface ensures that both researchers and participants can easily navigate the platform, making the clinical trial experience more streamlined and effective.

Data flows in from various channels, including EDC, EHR, smartphones, mobile devices, and central laboratories. Prism expertly integrates this diverse information and transforms it into usable knowledge. By combining user-friendliness with cutting-edge features, Prism EDC presents a modern approach to collecting and managing clinical trial data. Beyond traditional form-based data gathering, Prism also consolidates and organizes information from a wide range of sources. Additionally, Prism eSource offers a groundbreaking software solution that enables research teams to directly pull clinical trial data from a site's electronic health record (EHR). This innovation not only enhances efficiency and reduces costs compared to the existing model—where sites redundantly input the same data into multiple systems—but also speeds up the availability of new therapies to patients in need. As a result, the healthcare industry stands to benefit significantly from the streamlined processes that Prism facilitates.

Modern Interactive Response Technology (IRT) systems are becoming more intricate. The significance of flexible and customizable IRT cannot be overstated, as this technology serves as the primary source for essential data, including recruitment metrics, clinical trial attrition rates, patient attendance, and more. It is vital to select a platform that is intuitive, optimized for mobile use, and all-encompassing—underpinned by high standards of quality, adaptability, and expertise. Embrace a partnership that offers profound therapeutic knowledge tailored to the contemporary risk-based eClinical landscape. By merging advanced technology with specialized knowledge and a dedication to exceptional service, we enhance clinical trials to achieve favorable patient results. Our extensive understanding of clinical processes and supply chain dynamics fosters innovation, granting clients greater control over their Randomization and Trial Supply Management (RTSM) protocols. Our cutting-edge tools elevate quality assurance, improve site productivity, and enhance patient adherence significantly. Furthermore, our IRT platform is adaptable enough to cater to a wide array of studies, with the capability for full validation and deployment in just 30 days, ensuring efficiency in clinical trial operations. This swift implementation can lead to more timely data collection and improved overall trial management.

Clinpal stands out as the premier comprehensive clinical research platform specifically designed for virtual, hybrid, and direct-to-patient studies. Patients can access the platform from any location using various devices, ensuring convenience and accessibility. Research teams can harness robust data and analytics throughout the entire duration of the trial, while sites benefit from having all necessary functionalities consolidated into one user-friendly system, thus alleviating their workload. With Clinpal Build, users can utilize an intuitive point-and-click interface that allows Contract Research Organizations (CROs) and others to swiftly and effortlessly define data, forms, and workflows. The platform's Single Platform feature offers complete support for clinical trials, encompassing everything from patient recruitment and data capture to long-term follow-up, with data readily available as needed. Clinpal’s cutting-edge technology is designed to accommodate multiple formats, providing a unified online configuration; by setting it up once, it seamlessly operates for users on browsers, mobile devices, or applications. This innovative approach ensures that researchers and participants alike can engage with clinical trials in a streamlined and efficient manner.

Most Easy-to-Use Clinical Trial Management System (CTMS) 𝐂𝐥𝐢𝐧𝐢𝐨𝐧 𝐂𝐓𝐌𝐒 integrates seamlessly with Clinion EDC and Clinion RTSM to provide detailed and faster access to the entire trial process to address all aspects of Clinical trial management from a single platform: investigator sites, patients enrollment, SAEs, deviations, inclusions, visit scheduling, IP management, milestones, finances, custom reports, and on-demand analytics enables you to improve quality, control risk, and reduce costs. Clinion CTMS is modular in design These modules are available: Admin Module Project Management Site Monitoring Activities Finance and Budget Management Safety Reporting Management of IP Inventory Document Management System Audit/Activity Log Comprehensive dashboards Comprehensive Reports

Science 37 is a pioneering clinical research organization that focuses on decentralized clinical trials through its innovative Metasite model, which eliminates the need for physical proximity, allowing patients to engage in studies from virtually anywhere. This method significantly broadens accessibility, reaching over 90% of individuals who might be excluded from conventional site-based research, and harnesses the recruiting capabilities equivalent to 20 sites in one location, thereby offering patients the flexibility they desire. The Metasite operates on a proprietary platform that not only streamlines study orchestration but also facilitates the workflow for both patients and research staff, all while efficiently capturing study data without manual reentry. By centralizing personnel, processes, and technologies, this approach guarantees built-in protocol compliance, which leads to enhanced compliance rates and the collection of high-quality data. Science 37's dedicated in-house medical teams, telemedicine investigators, and mobile nursing professionals are well-versed in the conduct of remote trials spanning various therapeutic areas, thus ensuring comprehensive outreach. This commitment to innovative trial methodologies positions Science 37 at the forefront of transforming the landscape of clinical research.

ClinSoft™, was developed in-house by Innovate Research. There were no third-party acquisitions and integrations. The system is compliant to FDA regulations (21 CFR Part 11, as well as GCP and HIPAA. The system is fully auditable and validated. ClinSoft™, which is easy to use, ensures quick start-ups and close-outs. This saves you precious time and allows you to be certain that any mid-study amendments or updates to protocols will be made promptly. Innovate Research, an Indian contract research company, provides services in clinical research and regulatory affairs. US FDA 21 CFR Part 11 compliant. Electronic Signatures & Records Secure, Role-Based Access. Audit Trail. Easy to use interface for Edit Checks and CRF Set-up. Frameworks that can be reused for item, panel, visit, and page.

Lindus Health is transforming the landscape of clinical trials by providing an all-encompassing solution that yields quicker and more dependable outcomes. Our holistic methodology combines full-service CRO functions, operational site management, and cutting-edge technology, enhancing every facet of your study from initial design to final data delivery. Utilizing our nimble in-house technology, we accelerate the setup of sites and the recruitment of patients, tapping into a vast pool of over 30 million electronic health records to speed up enrollment. Our pricing model, which operates on fixed milestones and pay-on-results, aligns incentives effectively, removing the risk of unforeseen expenses and delays. With an impressive average satisfaction rating of 9.7 out of 10, our dedicated and experienced clinical operations team is committed to achieving excellence at every stage. Lindus Health has quickly broadened its global footprint, successfully conducting more than 91 trials across diverse therapeutic areas, such as metabolic health, women's health, diagnostics, and medical devices, all while maintaining a focus on innovation and quality in clinical research. This relentless pursuit of efficiency and reliability makes Lindus Health a leader in the industry.

TrialKit is a cloud-based platform available via both a web and native mobile app, enabling end-to-end clinical trial management for medical device, diagnostics, digital therapeutics, and biopharma companies of all sizes. Design and deploy validated studies in days not weeks using our intuitive study builder that requires no programming. Thousands of global users have leveraged the flexibility of TrialKit to deploy over 8,000 studies across all phases of development.

Enhance the efficiency of regulatory operations within your organization to bolster compliance and facilitate research advancements. Veeva SiteVault simplifies the process of managing clinical trials by integrating your regulatory tasks, leading to improved effectiveness and adherence to regulations. You can oversee regulatory and source documents through a unified platform that complies with 21 CFR Part 11 and HIPAA standards. With real-time insights across all trials, SiteVault Enterprise boosts operational effectiveness, accelerates study initiation, and fosters swift, high-quality trial management. Transition away from manual workflows and customize your own processes to enhance both quality and speed in study activation. By granting monitors secure, direct access to your regulatory and source documents, you eliminate the hassles of EMR access and document redaction. Furthermore, you can tailor your workflows, generate reports, and create dashboards to gain deeper insights into start-up timelines and regulatory workflows, ultimately driving better outcomes for your clinical trials. This comprehensive approach not only streamlines processes but also enhances collaboration across teams.

Signant Health operates as a worldwide leader in evidence generation, striving to transform the landscape of clinical trials by connecting with patients in their environments and rethinking the route to validation. Their extensive range of clinical technology solutions includes electronic Clinical Outcome Assessments (eCOA), Electronic Data Capture (EDC), electronic clinician evaluations, and a cohesive eClinical platform. Additionally, they offer patient engagement solutions featuring a user-friendly app, eConsent for informed consent processes, and telemedicine functionalities. Furthermore, Signant Health delivers clinical data and analytics services, which include COA data analysis as well as the aggregation and interpretation of data. With a rich history spanning over three decades, they have played an instrumental role in supporting numerous trials and have been pivotal in hundreds of drug approvals, establishing themselves as a reliable ally for sponsors and CROs eager to provide high-quality data for informed trial decisions and regulatory submissions. Their commitment to innovation continues to shape the future of clinical research.

Complion's platform was designed for clinical researchers. Our solution ensures compliance at the highest level with the lowest effort and the most efficiency. This allows you to concentrate on what really matters: improving and advancing patient outcomes. Our eReg solution is available to all clinical trial stakeholders, whether you are a Sponsor, Research Site or CRO. Reduce costs, avoid redundancy and increase staff productivity. You can easily archive, view and get signatures from any device. An audit trail is built into the system to ensure accuracy and eliminate patient safety risks and study conduct. Our clients include hospitals, cancer centers, and medical centers as well as multi-specialty clinics and dedicated research sites.

Clinevo's Clinical Trial Management System (CTMS) is a comprehensive, cloud-based platform designed to efficiently oversee every facet of clinical trials while being highly customizable. It adheres to all necessary regulatory standards, encompassing security measures, access management, change control protocols, audit trails, and system validation processes for optimal compliance and reliability.

DatStat’s cloud-based platform prioritizes the patient, whether in the context of care or the next significant clinical trial. This innovative platform enhances the ability of clinicians and researchers to engage, empower, and connect with patients like never before. Our solutions for clinical trials and healthcare are built on this patient engagement platform, which is utilized by some of the most forward-thinking healthcare organizations today. By collaborating closely with clients to grasp the unique requirements of their department, program, or initiative, the DatStat team customizes solutions within our web-based platform without the need for hard coding. In essence, we can expedite the launch of your project more efficiently than traditional custom coding or paper-based methods. By placing patients at the forefront, they can actively participate in the process, fostering better communication and enhancing your team's efficiency—all while contributing to improved outcomes for the patients themselves. As a result, our approach not only streamlines operations but also elevates the quality of care provided to patients.

The BizNET-CTM suite offers a comprehensive clinical trials management solution tailored for various sectors, including Contract Research Organizations (CROs), pharmaceuticals, biotechnology, and medical device industries. This versatile platform empowers CROs to effectively plan, manage, design, execute, monitor, and analyze activities and data related to clinical trials, ensuring compliance with both protocol obligations and regulatory standards. It serves as an all-encompassing solution that addresses the entire clinical research project lifecycle, beginning with project management and feasibility assessments, advancing through volunteer or patient enrollment facilitated by iris recognition technology, and encompassing the capture of trial data. The platform incorporates a multi-tiered review process, data compilation, and eventual data archiving, ensuring thorough oversight. Moreover, the BizNET-CTM suite is specifically crafted to oversee all necessary documents, tasks, processes, relationships, audits, and training that must be managed throughout the entirety of a clinical trial, thereby streamlining operations and enhancing efficiency in clinical research. This innovative approach not only simplifies complex processes but also enhances the accuracy and reliability of trial outcomes.

Zelta is a cloud-powered platform for unified clinical data management and acquisition, designed to streamline and enhance clinical trial processes. Its modular architecture adapts to the unique demands of each study, enabling faster and more efficient outcomes. With capabilities such as electronic data capture, clinical operations management—including randomization and trial supply tracking—clinical trial management, and electronic trial master file functionality, Zelta supports comprehensive study oversight. It also enhances patient and provider engagement with electronic clinical outcome assessments and e-consent solutions. Built for studies across all phases, therapeutic areas, and global regions, Zelta offers an intuitive user experience with secure single sign-on access from anywhere. Its flexible and scalable design allows for seamless customization and integration with both native and third-party technologies, ensuring adaptability to diverse research needs.

We create innovative solutions that enhance and strengthen the clinical trial ecosystem. Our platform for Enrollment Performance Management is favored by research sites and relied upon by sponsors. It is utilized by 2,000 research sites in 26 countries and is endorsed by half of the world's top-20 biopharma companies. This enables sites to reduce time spent on repetitive and manual activities, facilitating a smoother patient progression. By minimizing redundant efforts, there are fewer logs, phone calls, and emails required from both sites and sponsors. Sponsors can proactively improve enrollment with immediate access to advanced pre-screening and enrollment metrics. Our remarkably straightforward patient recruitment and enrollment solution is trusted by over 1,800 sites worldwide. Gain access to impactful recruitment and enrollment insights, ensuring clinical trials are conducted faster and with greater predictability. By eliminating unnecessary tasks, sites can refocus their efforts on what truly matters: providing assistance to patients. Effortlessly manage recruitment across all trials, sponsors, or CROs with the ability to input information once and have it directed where it is needed most. This innovative approach not only streamlines the process but also enhances collaboration among all stakeholders involved in clinical trials.

We offer a comprehensive tracking solution designed specifically for clinical trials. With a simple download onto your trial managers' mobile devices, you can relax as TruLab's advanced blockchain technology handles all the complexities. There's no need to wait for samples to arrive at a central lab to identify potential issues; instead, you can detect data anomalies in real-time as samples progress through the clinical trial process. TruLab facilitates continual remote accessioning of samples, addressing the significant concern that 20% of samples are either lost or deemed unusable during late-stage trials. This situation is unacceptable from ethical, logistical, and financial perspectives. Furthermore, with sample collections increasingly taking place at participants' homes, new challenges in tracking these samples arise. TruLab effectively monitors samples wherever they are located, ensuring that they are accounted for from residences to repositories, thus enhancing the overall integrity of the clinical trial process. By providing seamless tracking capabilities, TruLab empowers trial managers to mitigate risks and improve outcomes.

ClinEdge is revolutionizing the clinical trial landscape by offering a robust array of services designed specifically for Sponsors, CROs, and Sites. By employing creative and collaborative problem-solving techniques, we address the challenges and obstacles our clients encounter. Our commitment to enhancing trial success spans every phase of each study, ensuring that Sponsors and CROs have optimal Site and Patient Access while providing Site partners with improved Trial Solutions. With more than ten years of industry experience and a profound insight into our clients' needs, ClinEdge is dedicated to transforming the way studies are conducted, paving the way for more efficient and effective clinical trials. Through innovation and dedication, we aim to set new standards in the clinical trial sector.

Clinical One RTSM is capable of accommodating various randomization strategies, ranging from the most straightforward to highly intricate studies, all without requiring any programming or coding, which consequently reduces the duration of user acceptance testing. You can take charge of your study with self-service configurations, allowing you to develop a study in just a matter of days rather than weeks. Additionally, you can assess the drug inventory status and make real-time adjustments without needing to consult the vendor, thereby avoiding unnecessary costs and change requests. By implementing changes swiftly, you can eliminate expenses associated with change requests and prevent delays, enabling you to launch your studies almost instantaneously. This platform stands out as the only one that genuinely integrates individuals, processes, and data to streamline and expedite the future of clinical trials. Moreover, the inclusion of virtual components in clinical trials enhances patient engagement and significantly elevates the quality of trial data. To keep pace with the rapidly evolving landscape, it is essential to adopt transformative digital strategies that facilitate quicker study initiations, harmonize data from diverse sources, and optimize workflow efficiency. Such advancements are pivotal for the successful execution of modern clinical research initiatives.

Ripple, a web-based software solution that allows for the management and recruitment of research participants in clinical, translational, and social science studies is an active registry. Ripple was developed by researchers to transform the participant workflow. It is an end-to–end research participant management system that speeds up the entire research process.

Experience the forefront of eSource, CTMS, and eRegulatory software designed specifically for clinical trial sites. With CRIO’s top-tier electronic source, you can effortlessly capture source data in real-time, drastically cutting down on paper usage by up to 90% while enhancing data quality by 80%. Gain command over your operations through CRIO’s user-friendly Clinical Trial Management System, allowing you to efficiently schedule patients, monitor financials, and optimize recruiting processes. We proudly present cutting-edge electronic regulatory binders, including the innovative first-ever electronic delegation log, all compliant with 21 CFR Part 11 standards. For clinical trial sponsors, you can perform 100% remote monitoring of your sites’ source data and regulatory documents through a secure online portal. Become a part of our extensive network of over 500 clinical research sites worldwide. Our commitment is to facilitate the growth of your business by streamlining your site’s operations, ensuring that your studies can continue smoothly, regardless of whether you're on-site or not. This way, you can focus on what truly matters: advancing your clinical research initiatives.

ClinAccess™ 5.1 represents the evolution of our premier Clinical Data Management System, built entirely on the robust SAS® 9 platform. This innovative system paves the way for streamlined clinical data management, efficient clinical trial analysis, and seamless preparation of electronic submissions. By integrating data entry directly into SAS® data sets, it significantly boosts your team’s efficiency by removing the cumbersome process of transferring data from Oracle/SQL to SAS. ClinAccess™ is specifically tailored for user-friendly study definition, data entry, and management, featuring tools that track the progress and quality of ongoing clinical trials. Your data is consistently maintained in SAS® for easy access, whether for review, analysis, or submission to the FDA. The underlying database architecture is optimized to facilitate rapid statistical analysis and reporting. Consequently, users can expect reduced time and effort in data analysis, ultimately leading to a faster time to market. Additionally, ClinAccess™ stands out for its reliability, comprehensive auditing capabilities, and robust security measures, making it an unparalleled choice for clinical data management. With ClinAccess™, you can confidently navigate the complexities of clinical trials while ensuring data integrity and compliance.

Uncover the most cutting-edge methods in the realm of clinical and patient-reported outcomes data. Our comprehensive solution transcends mere data entry, facilitating a genuinely patient-focused research experience. While our eCOA software is deeply rooted in principles of behavioral science, it has also been designed specifically by healthcare professionals to align with the needs of both sites and sponsors. By emphasizing personal identity, motivational intervals, and significant objectives, we stand out from other eCOA solutions. The Datacubed app features a user-friendly interface that allows participants to quickly engage with what truly matters. It has been highlighted that gathering data is now more straightforward than ever, thanks to our adaptable, user-friendly, and interactive application. As the need for flexibility in trial design continues to grow, we provide versatile data collection options that can be executed in person, remotely, or as a hybrid approach, catering to the diverse requirements of traditional, hybrid, and virtual clinical trials. This adaptability ensures that researchers can effectively capture the most relevant data, regardless of the study format.

VACAVA offers healthcare solutions that simplify and reduce the costs associated with managing regulatory documents for clinical trials. The reliance on manual workflows can lead to delays and the risk of losing important information whenever documents are transferred. By utilizing VACAVA's solutions, you can enhance your regulatory processes by centralizing profiles, forms, and documents in a single, easily accessible online platform. With electronic approvals in compliance with 21 CFR Part 11, documents transition smoothly throughout your workflow. User-friendly dashboards provide efficient oversight, making management straightforward. Developed in partnership with a leading clinical trial research organization, VACAVA’s Regulatory Document Management System is designed to streamline operations and significantly boost efficiency. Additionally, it is surprisingly cost-effective and can be tailored to suit your specific requirements. VACAVA’s offerings are not only flexible and scalable but also delivered through the cloud, eliminating concerns about server management, security, and data backups. This means organizations can focus more on their research and less on technical hurdles.

Datatrak International, Inc. is a software-as-a-service provider of enterprise cloud-based technologies for the life sciences industry. Datatrak's unified eClinical solution and related services improve efficiency and cost effectiveness for the clinical trial industry. Datatrak developed its multi-component, comprehensive solution using a single platform. This concept was expanded to include services delivery through Datatrak's Clinical and Consulting Services groups. The Company offers a complete range of software products that can be used to speed up the reporting of clinical research data to sponsors and regulators. This is faster than using loosely integrated technologies. Our goal is to empower workgroups with role-based access, version-controlled file management and calendar events, tasks, and contacts. All built within our eClinical software applications, including EDC, CTMS and reporting.

Enhance the quality of data management by directly capturing eSource data during patient interactions. This process incorporates integrated editing and validation mechanisms, allowing users to electronically gather high-quality information, which significantly minimizes errors and inquiries, while facilitating real-time remote oversight. By doing so, the study duration, expenses, and risks are significantly reduced. FDA-endorsed, this innovative eSource approach simplifies and modernizes clinical trials, effectively replacing slow, error-prone monitoring and the transcription process into electronic data capture (EDC) systems. Additionally, tailored for site users, ez-SourceDocx optimizes workflows, alleviates workloads, and ensures adherence to study protocols by guiding sites through properly sequenced visit procedures, which not only confirm the collection of all endpoint data but also encourage timely quality assessments by investigators. Ultimately, this comprehensive system enhances overall clinical trial efficiency and reliability.

Streamline your document workflows to eliminate inefficiencies that consume valuable time and resources, hindering your growth and ability to secure new studies. Florence eBinders seamlessly connects all your clinical trial systems, automates eRegulatory tasks, shortens contract negotiation duration, monitors study advancement, and facilitates secure remote oversight on a leading eRegulatory, eISF, and eSource platform. With our highly-rated implementation and support teams, your team and study can be set up quickly, ensuring a smooth transition for all users. Most sites become fully operational within just four weeks! By enabling secure access for your monitors and providing remote capabilities for your team, you can significantly decrease the time spent on-site during monitoring visits. Additionally, this approach fosters a more efficient and flexible research environment.

Discover a comprehensive platform designed for researching, documenting, and organizing your clinical data seamlessly. The Nucleus platform streamlines your research data management, providing a unified space for storing study documentation, clinical datasets, submission materials, and compliant media. With Nucleus Documents, you can efficiently manage documents and maintain version control for your quality documentation and media assets. Easily oversee, manage, and share your organizational content without hassle. Additionally, effortlessly compile and regulate your electronic trial master file documents through our centralized regulatory document management system. Nucleus Coding facilitates dictionary term coding for both MedDRA and WHODrug dictionaries, available as a standalone application or integrated within your data capture system, ensuring flexibility and efficiency in your coding processes. This comprehensive solution not only enhances data integrity but also optimizes collaboration across your research teams.

Mahalo Health is an integrated digital health platform aimed at expediting the creation of patient-focused digital health solutions and clinical trials. By providing a variety of prebuilt modules, Mahalo facilitates the swift launch of customizable white-label applications that cater to particular therapeutic fields. The platform boasts comprehensive data capabilities, featuring a predictive health engine for forecasting diseases and diagnoses, a behavior modification engine to encourage beneficial patient behaviors, and a notification system that ensures timely communication through push notifications, SMS, or emails. Committed to maintaining high security and compliance standards, Mahalo follows regulations such as HIPAA, GCP, ISO27001, and GDPR. Its extensive range of services encompasses multiple therapeutic areas, including diabetes, cognitive health, cardiovascular issues, musculoskeletal conditions, mental health, oncology, rare diseases, and nonalcoholic steatohepatitis (NASH). Additionally, Mahalo Health empowers healthcare providers with tools to enhance patient engagement and outcomes through its innovative digital solutions.

Clinevo's electronic Trial Master File (eTMF) is a user-friendly digital solution for the organization and storage of documents, images, and various digital assets related to clinical trials. This eTMF incorporates an integrated DIA reference model and complies with regulatory standards. Additionally, Clinevo offers the MICC Intake, a web-based platform designed for Medical Information Call Centers (MICC) and Pharmacovigilance (PV) professionals to efficiently log, track, and monitor Product Quality Complaints (PQCs), Medical Inquiries (MIs), and Adverse Events (AEs). Furthermore, Clinevo Safety serves as a comprehensive cloud-based system that ensures ease of use and regulatory compliance throughout the entire Pharmacovigilance process, encompassing PV Intake, Case Processing, Regulatory Submissions/AS2 Gateway, Analytics, and Safety Signals, all within a single platform. Lastly, the Clinevo Website Intake tool can seamlessly integrate with Sponsor or CRO websites, offering consumers and reporters an intuitive web interface for easy access and reporting. This innovative suite of tools enhances the efficiency and effectiveness of clinical trial management and safety reporting.