FICS Alternatives

Globally accessible, infinitely scalable, AI-powered, collaborative cloud platform meeting the highest standards of security and compliance. An industry-leading and simple-to-use software platform, purpose-built by neuroimaging and data science experts to meet the distinct and challenging needs of the neuroscience community. Optimized and tailored for your needs, whether you are conducting research, running clinical trials, at the point of care, developing novel algorithms or leveraging brain-related data. Global data aggregation, and consolidation of imaging-based studies in one cloud platform. Streamlined, end-to-end clinical, real-world data and medical imaging data management. End-to-end expert and personalized support to ensure your study success. Centralized reading and the ability to compare quantitative results to a normative database. Highest quality, shareable reporting and data exporting for submissions approval.

Clinical trials and research traditionally existed outside of the care administered within local hospitals and physicians’ offices. Physicians weren’t always aware of what research was being conducted, and patients had little idea research that could potentially improve their outcome or benefit their health was occurring at all. Only Elligo enables broader participation in clinical research than ever before with access to over 150 million patients and their data, allowing physicians to provide research as a care option to patients who otherwise wouldn’t have access to clinical research. Traditional recruitment methods are constrained by limitations such as patient proximity to a specific site where research is conducted. Research has also shown that patients prefer to engage in a study with their trusted healthcare physician.

Deep 6 AI disrupts the clinical trial enrollment process by transforming the way researchers identify eligible patients. Using artificial intelligence and natural language processing to mine structured and unstructured patient data, DEEP 6 AI finds more, better-matching patients for trials in minutes, not months. Deep 6 AI works with some of the most prominent health systems, pharma companies, and CROs in the world --making the DEEP 6 platform a crucial step in their clinical research workflow and greatly accelerating patients’ access to clinical trials. Deep 6 AI finds more patients for clinical trials in minutes rather than months, getting life-saving cures to people more quickly. Deep 6 AI’s software analyzes structured data, such as ICD-10 codes, and unstructured clinical data, including doctor’s notes, pathology reports, operating notes and other important medical data in free-text form that cannot be searched easily.

The Medidata Clinical Cloud is our cutting-edge platform that transforms the clinical trial experience for patients, sponsors, CROs, and research sites. As the only unified technology platform dedicated to clinical research, the Medidata clinical cloud addresses the holistic research process from start to finish. Our platform helps life science and medical device organizations cut development costs, mitigate risks, and deliver treatments and devices to market faster. No matter which products you choose for your clinical trial program, you will have access to the power of the Medidata Clinical Cloud. At Medidata, we’re leading the digital transformation of clinical research. Powered by artificial intelligence, machine learning and advanced analytics, our platform brings researchers, study managers, investigators, and patients together to accelerate research. Obtain regulatory-compliant, patient-friendly electronic informed consent for clinical trials.

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. Cloudbyz provides end-to-end management of the clinical trial lifecycle, including study setup, site management, study projections, monitoring, and financial management. With Cloudbyz, you can optimize your study planning, accelerate patient recruitment, and increase trial quality, while reducing costs and minimizing risk.

TCS ADD platform accelerates speed-to-market for pharmaceutical industry across the entire clinical R&D value chain and helps make clinical trials more agile and safe. TCS ADD enables digital ecosystems, simplifies data complexity and provides faster access to new and effective drugs for the patients. The platform is powered by cognitive artificial intelligence engine called TCS Decision FabricTM, smart analytics and IoT that provides superior business value to pharmaceutical industry. A next-generation and end-to-end metadata-driven solution to manage industry & sponsor clinical standards. A data science-driven platform that leverages AI & ML technologies to enable quicker decisions, faster study start-up and targeted interventions. A solution that digitizes the entire clinical trial supply management process while putting the patient in the center, increasing patient’s safety and overall efficacy.

Data comes at you from all directions – EDC, EHR, smartphones, mobile devices, central laboratories. Prism assimilates data from these disparate sources and transmutes them into information and ultimately knowledge. Prism EDC combines ease-of-use with innovative features to provide a fresh solution for the collection and management of clinical trial data. Prism offers more that than form-based data collection, it aggregates and manages data from a myriad of data sources. Prism eSource is an innovative software solution that allows research teams to extract clinical trial information directly from a site’s electronic health record (EHR). This creates efficiencies and cost savings beyond the current paradigm where sites must enter the same data in multiple systems and accelerates the delivery of novel therapies to patients.

Clinpal is the first end-to-end clinical research platform purpose-built for virtual, hybrid and direct-to-patient studies. Patients log in from anywhere, on any device. Study teams leverage powerful data and analytics across the entire lifespan of the trial. And sites get all functionality all in one system, reducing burden. Clinpal Build provides a point-and-click studio, enabling CROs and others to define data, forms and workflow quickly, and easily. Clinpal’s Single Platform – provides end-to-end clinical trial support from patient recruitment and data capture through long-term follow up, with data available on demand. Clinpal’s Innovative Technology – we designed Clinpal to work in multiple formats, with a single online configuration. Configure one time, and Clinpal works for browser, mobile or app users.

Streamline regulatory operations across your organization to improve compliance and advance research. Veeva SiteVault reduces the complexity of conducting clinical trials by connecting your regulatory operations to improve efficiency and compliance. Manage regulatory and source documents in a single system that supports 21 CFR Part 11 and HIPAA requirements. With a real-time visibility across trials, SiteVault Enterprise improves operational efficiency, speeds study activation, and enables faster, higher-quality trial execution. Replace manual processes and design your own workflows to support quality and speed study activation. Eliminate the need to grant EMR access or redact documents by providing monitors with secure, direct access to your regulatory and source documents. Create your own workflows, reports, and dashboards for greater visibility into start-up timelines and regulatory processes.

Advancing AI to eliminate trial and error in medicine. Our digital twins enable confident and quick clinical trials. We work in neuroscience, immunology, metabolic disease, and more. TwinRCTs reach full enrollment sooner because they require fewer patients to achieve the same power as traditional trial designs. Shorten time to enrollment in late-stage studies. TwinRCTs improve the ability to observe treatment effects in early-stage studies by increasing power without adding more patients. Make confident decisions from early-stage studies and attract study participants. TwinRCTs give participants a greater chance of receiving the experimental treatment because they use smaller control groups. Position clinical trials with digital twins for regulatory success. Unlearn is engineering the future of medicine with artificial intelligence. We invent and deploy new types of generative models trained on extensive patient-level data from previous studies.

Jeeva's patent-pending modular solution is designed from the ground up on the most powerful cloud platform with one login from any browser-enabled mobile device for remote patient screening, education, enrollment, electronic informed consent, bi-directional communications via video calling, telemedicine, SMS, email, and evidence generation including electronic patient-reported outcomes and clinical outcomes assessments, with a modern user experience. Delays in patient recruitment & retention are keeping them up at night. Generating enough evidence of safety and efficacy of investigational new medicines is critical to get timely approval from regulatory agencies. Whether you are a patient group setting up a registry or natural history study, or a biopharma sponsor of a clinical trial, or a long-term follow-up study for gene therapy, Jeeva can save you time, and money while improving user experience for study team and trial participants.

Complion’s platform is the accepted standard built specifically for clinical researchers. Our solution ensures the highest level of compliance with the greatest efficiency and the least amount of work. Allowing you to focus on what really matters — advancing and improving patient outcomes. Whether you are a Research Site, Sponsor or CRO, our eReg solution can help you address any type of clinical trial challenge, now and in the future. Reduce costs, avoid redundancy, and increase staff productivity. Easily archive, get signatures and view files from anywhere or from any device. A built-in audit trail ensures accuracy and eliminates study conduct and patient safety risks. Our clients include leading cancer centers, medical centers, hospitals, and health systems, as well as multi-specialty practices and dedicated research sites.

Unlock better evidence with high-quality ePRO and eClinRO. Electronic Clinical Outcome Assessments, or eCOA, measure how patients feel or function during clinical trials. By capturing clinical data electronically, you can be confident that your patient’s data is high-quality and regulatory-compliant. Put simply, eCOA avoids the quality and time issues associated with paper diaries, such as illegible answers, transcription errors and inconsistent or conflicting data. Also, the FDA recommends ePRO. Patient-reported outcomes, patients report on their health via questionnaires or assessments. Examples include quality of life or activity outcomes. The clinician reported outcomes. Health outcomes are reported by a clinician. An example may include a physical examination such as PASI. Performance outcomes are measures from specific tasks the patient is asked to perform. An example might be performing a timed task.

DatStat’s cloud based platform puts the patient at the center, whether at the center of care, or the center the next big clinical trial. Our platform is helping clinicians and researchers engage, empower, and connect with patients like never before. DatStat clinical trial and clinical care solutions are based on our cloud based, patient engagement platform, used by today’s most innovative, leading healthcare organizations. Working closely with customers to understand the specific needs of their department, program, or project, the DatStat team will configure, not hard-code, your solution into our web-based platform. Simply put, we can get your project launched much faster than custom, hard-coded, or paper based solutions, and by putting patients at the center, they get directly involved in the process – improving communication and making your team more effective, all while improving their outcomes.

Consists of clinical trials management solution suites for various CROs, Pharmaceutical, Biotech and Medical device industries. BizNET-CTM, is a multi-functional platform which allows a CRO (Contract Research Organization) in planning, managing, designing, executing, monitoring and analyzing trial related activities and data in adherence to the protocol obligations and regulatory requirements. An end-to-end solution suite which cater to the needs of clinical research project starting from Project Management, feasibility assessment, volunteer or patient enrollment using iris recognition technology, capture clinical trial data, multi-level review process, data compilation to data archiving. The BizNET-CTM suite is designed to manage all of the documents, tasks, processes, relationships, audits, and training that must be administered and controlled throughout the life of a clinical trial.

Ripple is a web-based software solution and active registry that facilitates the recruitment and management of research participants for clinical, translational and social science studies. Built from the ground up by researchers for researchers to truly transform participant workflow, Ripple is an end-to-end research participant management software that accelerates the entire research life cycle. Applying technology to solve patient recruitment and retention challenges, the #1 reason cited when clinical trials fail. The success of clinical trials and translational studies greatly depends on the ability of research teams to meet enrollment targets on time and on budget. Ripple Recruit empowers research teams with the automation tools and analytics necessary to accelerate the recruitment processes and maximize the likelihood of study success. Ripple Recruit provides critical insights into your recruitment campaign and workflows, including what sources are most effective.

We build solutions that connect and empower the clinical trial ecosystem. The Enrollment Performance Management platform that sites love and sponsors depend on. Used by 2,000 research sites across 26 countries and by half of the top-20 global biopharma companies. Sites spend less time with redundant and manual tasks so that they can move patients forward. Less double work for sites. Fewer logs, phone calls, and emails for both sites and sponsors. Sponsors can optimize enrollment proactively with real-time access to novel pre-screening and enrollment data. Surprisingly simple patient recruitment and enrollment solution trusted by more than 1,800 sites across 26 countries. Access powerful recruitment and enrollment insights to run faster, more predictable clinical trials. Eliminate redundant work so you can get back to the work that matters most: helping patients. Manage recruitment across all trials, sponsors, or CROs. Enter information once and it goes where you need it to go.

Today’s Interactive Response Technology (IRT) systems are increasingly complex. Flexible and configurable IRT matters - with IRT data as the source of record for recruitment, clinical trial drop-out rates, patient visits, and other crucial data. Choose a platform that’s user-friendly, mobile-ready, and comprehensive - embedded in quality, flexibility and expertise. Choose comfort with complex therapeutic expertise in today’s risk-based eClinical environment. Combining the right technology, subject matter expertise and commitment to service we empower clinical trials to deliver patient outcomes. Deep clinical and supply chain knowledge drives innovation and provides clients with control over their Randomization and Trial Supply Management (RTSM) processes. Our innovative suite of tools drives distinctive levels of quality control, site efficiency and patient compliance. Our IRT platform can meet the needs of almost any study, enabling fully validated deployment in as little as 30 days.

The industry’s leading eSource, CTMS, and eRegulatory software for clinical trial sites. Capture source data seamlessly and in real-time with CRIO’s best-in-class electronic source. You’ll eliminate up to 90% of your paper and improve data quality by 80%. Take control of your operations with CRIO’s intuitive Clinical Trial Management System. Schedule patients, track financials, streamline recruiting, and more. Introducing electronic regulatory binders fit for the 21st century, which includes the first-ever electronic delegation log — all 21 CFR Part 11 compliant. For clinical trial sponsors: conduct 100% remote monitoring of your sites’ source data and regulatory documents in a secure, online portal. Join Our Network of 500+ Clinical Research Sites From Around The World. Our mission is to help you grow your business. We do that by streamlining your site’s operations, so that your studies don’t stop just because you aren’t in clinic.

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. Our Clinical Trial Management System allows CROs and Sponsors to monitor the trial progress actively with its advanced dashboard and alert notification system. So you’ll never miss a deadline again! What can you expect? Comprehensive CTMS Software Single Source for your entire trial data On-demand Analytics for Risk-Based Management of Clinical Trials Fully Integrated with Clinion EDC and Clinion RTSM 100% web-based and hosted securely on the cloud 21 CFR Part 11 & GD

Founded in 2010, Crucial Data Solutions (CDS) provides the most innovative low-code/no-code data and clinical trial management technology on the market today. TrialKit, our cloud-based platform available via both a web and native mobile app, enables end-to-end clinical trial management for medical device, diagnostics, digital therapeutics, and biopharm 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, including Verily (a subsidiary of Alphabet), ICON, Catalyst Clinical Research, SISCAPA Assay Technologies, CDx Diagnostics, and Optinose, and many more.

Innovate’s End-To-End Clinical Data Management Services. Our clinical data management processes, expertise and technology are developed to make each step of your clinical trial data management process more accurate and efficient for Phase I-IV in wide range of therapeutic areas. Our CDM Team Is Well-Versed With Current Good Clinical Data Management Practices (cGCDMP) International conference on harmonization Good Clinical Practices (ICH-GCP) 21 CFR Part 11 Compliance Health Insurance Portability and Accountability Act (HIPPA) Requirements Applicable Regulatory Guidelines SAS datasets SAS XPORT transport files EDC Helpdesk Support 24/7 On-Site and Off-Site Clinical Data Management Services Electronic Data integration and transfer Quality Control Activities Medical Dictionary for Regulatory Activities (MedDRA) Serious Adverse Event (SAE) Reconciliation Clinical Database Transfers Clinical Database Lock paper Case Report Form (pCRF) and electronic Case Report Form.

One Platform to Research, Document, and Collate your Clinical Data. Simplify your research data with the Nucleus platform. A single platform to store your study documentation, clinical datasets, submission data and compliant media. Nucleus Documents enables document management and version control for your quality documentation and media. Control, manage, and share company content with ease. Collate and control your electronic trial master file documents with ease using our centralized regulatory document management solution. Nucleus Coding enables dictionary term coding against both MedDRA and WHODrug dictionaries, either in our standalone application, or integrated into your data capture system.

Datatrak International, Inc. is a software-as-a-service provider of enterprise cloud-based technologies for the life sciences industry. Datatrak’s unified eClinical solutions and related services help improve cost and time efficiencies for the clinical trials industry. Datatrak built its multi-component, comprehensive solution on a single, unified platform and expanded this concept to include services delivery via Datatrak’s Clinical and Consulting Services group. The Company delivers a complete portfolio of software products designed to accelerate the reporting of clinical research data from sites to sponsors and ultimately regulatory authorities, faster and more efficiently than loosely integrated technologies. Our commitment is to empower workgroup teams with role-based access to version-controlled file management, calendar events, tasks and contacts, all built within our eClinical applications including EDC, CTMS, reporting, data analytics and business intelligence.

Healthcare solutions from VACAVA reduce the complexity and cost of clinical trial regulatory document management. Each time documents move through a manual workflow, it introduces the opportunity for delays and lost information. VACAVA solutions help you streamline regulatory processes by storing profiles, forms and documents in a single easy-to-access online location. Documents seamlessly move through your workflow with approvals captured electronically (21 CFR Part 11 compliant). Easy-to-read dashboards enable efficient management. VACAVA’s Regulatory Document Management System was built in collaboration with a major clinical trial research base to simplify operations and radically increase efficiency. VACAVA’s Regulatory Document Management System is surprisingly affordable and can be customized to meet your unique needs. VACAVA’s solutions are flexible, scalable, and delivered via the cloud so you never have to worry about managing servers, security, and backups.

Thousands of organizations around the world trust IQVIA to speed drug development, ensure product quality and safety, improve commercial effectiveness, get the right treatments to patients, improve access to and delivery of healthcare, and ultimately drive better health outcomes. Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster. With a foundation in data, advanced analytics, and expert insight, IQVIA brings specialized capabilities to customers across the healthcare ecosystem. Read and watch the latest from IQVIA data scientists, doctors, researchers, and other subject matter experts on the topics that matter to you. From industry trends to how we are applying our capabilities to help, you can find it here.

Mosio enables research teams to improve subject adherence, communications, and data collection on mobile’s most popular channel: text messaging. Our software makes research teams more efficient in how they communicate with study participants through messaging automation and interactive elements delivered to participant mobile phones. WHO WE HELP: + Clinical Trial Sponsors (Pharma and Biotech) + Cancer Centers and Clinical Research Organizations + NIH-Funded Studies + Public Health Agencies + Clinical Trial Managers, Clinical Operations Managers/Directors, Clinical Project Managers, Principal Investigators, Clinical Research (Study) Coordinators, and any research staff who communicate regularly with study participants. BENEFITS: + Interactive dosing reminders and medication adherence alerts. + Automate data collection. + Increase engagement and adherence. + Fix your no-show problem with SMS appointment reminders. + Improve retention with automated check-ins.

Gain visibility into all aspects of your research operations with a comprehensive, proven, and standardized clinical trial management system built through collaboration with leading academic medical centers and cancer centers. Centralize billing designation information to ensure consistency across multiple teams and systems. Improve your budgeting process, route charges correctly, and conduct more accurate auditing/monitoring of billing compliance. Gain visibility and insight into all aspects of clinical research, including comprehensive financial management, with a standardized system built in collaboration with top research institutions. Integrate OnCore with your current EMR, including turnkey interfaces with Epic and Cerner, to increase patient safety, reduce duplicate data entry, enhance billing compliance, and increase operational efficiency.

VIPER automates the screening process from remote patient identification (at the point of diagnosis) to qualified enrollment. Utilizing artificial intelligence, VIPER identifies and matches patients to precision trials in the narrow window of opportunity through lab-agnostic genomic data ingestion, EMR and pathology data in a way that is customized to both the patient and to the research. VIPER searches the customized matching engine to find the best available clinical trials for a patients’ specific diagnosis—at the time of diagnosis. Through workflow integration, VIPER sends real-time notifications of a patient's eligibility for available clinical trials to the entire care team in the narrow enrollment window. VIPER also provides real-time interactive dashboards with rich data mining capabilities to aggregate site and study level patient data to hit your study KPIs.

Clinevo Clinical Trial Management System (CTMS) is a cloud based, highly configurable, end-to-end platform which helps manage all aspects of clinical trials. It meets all the regulatory guidelines including security, access control, change controls, audit trails, and system validation.

Longboat is a cloud-based clinical trial support solution provides users with an integrated Guided Compliance toolset to guide them at all times. Longboat provides the clinical trial site staff with the right resources to let them focus on patients. Longboat allows patients to view essential study information and check visit reminders. Longboat allows users to seamlessly manage the controlled rollout of the amended clinical trial protocol. Centralize the secure exchange of regulated documents between sponsors, CROs, and sites, significantly streamlining study startup and eliminating historically cumbersome processes across research stakeholders. All key stakeholders—clinical operations, monitors, site staff, and participants—access one integrated support platform with content tailored to meet their specific needs. Provide your site staff the tools and resources they need to stay engaged and compliant while focusing on the participant.

IBM® Clinical Development provides pharmaceutical, contract research organizations and medical device companies unified technology from start up to submission to support clinical trials. With our clinical data management system, users can organize and analyze report data from anywhere in the world. Enabling pharmaceutical organizations to deliver therapies faster to their patients. Design and launch studies without database migration. Deliver quick and easy remote consent with minimal integration.

We provide a truly end-to-end tracking solution for use in clinical trials. Simply download the software onto your trial managers’ mobile devices and sit back as TruLab’s blockchain technology does the rest. Don’t wait until samples reach a central lab to spot potential problems. Spot data anomalies in real-time as samples work their way through the clinical trial. TruLab allows for constant remote accessioning of samples. 20% of samples are lost or deemed unusable in late-stage trials. Ethically, logistically, and financially, this is unacceptable. Samples are no longer exclusively collected at clinical sites. The new world of collection at residences presents a host of novel sample-tracking problems. TruLab tracks samples wherever they are in the world, from residence to repository.

ClinEdge is transforming the clinical trial industry by providing a comprehensive suite of services tailored for Sponsors, CROs and Sites. We creatively and collaboratively solve problems for our clients because we understand the challenges and barriers they face. ClinEdge is dedicated to improving overall trial success through every stage of every study by providing Site and Patient Access to Sponsors/CROs and enhanced Trial Solutions to Site partners. With over a decade of expertise and a deep understanding of our clients and the challenges they face, ClinEdge is focused on transforming and revolutionizing study conduct.

PicnicHealth connects patients and researchers to deliver the most complete, fit-for-purpose real-world data. By working directly with patients who contribute their medical data to research, we can build the most complete picture of patient health across all of their providers, not just one care site or specialist. Building the right cohort of patients is easy with our existing patient communities and rapid recruitment through dozens of established direct-to-patient channels. Patients sign up and consent to participate in 10 minutes and get access to their medical records. Do you have patients in ongoing registries or trials? Send them to PicnicHealth and we’ll get them set up. Our research platform delivers customized real-world data at the patient level. Specify the data elements to extract from medical records, including doctors' notes, narrative text, and more. Our unique, patient-centric approach to real-world data empowers patients to contribute more.

5thPort is a digital patient education, engagement and eConsent platform. It can be used across individual practices, hospitals, health systems, and in clinical research. The platform utilizes high quality, prescriptive multimedia and teach-back to educate patients and their caregivers on their diagnosis, care plans, risks and benefits of recommended procedures. Once the patient is well-informed, our digital eConsent process helps to facilitate a meaningful conversation with your healthcare provider. With 5thPort, achieve the following results: 1. Save 15 to 20 minutes per consult (without spending any incremental effort) 2. Enhance the patient experience 3. Reduce patient stress on the day of their appointment 4. Empower patients to actively participate in their healthcare conversations with their provider 5. Reduce nurse burnout

Discover the industry’s most innovative approach to clinical outcomes and patient-reported outcomes data. For instance, our robust solution extends beyond simple data entry capabilities and enables a truly patient-centric study. While our eCOA software is rooted in behavioral science, it is also purpose-built by clinicians to meet the expectations of sites and sponsors. Personal identity, coupled with motivational intervals, and meaningful goals. Unlike other eCOA solutions, the Datacubed app has an easy-to-use interface allowing participants to get right to what’s essential. As has been noted, collecting data has never been easier, thanks to our intuitive, flexible, and interactive app. Flexibility in trial design has become paramount; for this reason, we offer data capture in person, remotely, or in combination to meet the needs of traditional, hybrid, and virtual trials.

Until now, the options available for managing clinical trials at an investigator site were either keeping multiple shared spreadsheets or buying expensive software unsuited to Australian conditions. MAISi is the game-changer. Beginning as a repository for clinical trials data at a major hospital in 2001, MAISi has evolved into a sophisticated workflow application to assist in most aspects of a research unit’s operations. MAISi acts as a central repository of data to store information about studies and the business units that run them. The datasets are arranged to support management decision-making. Staff in each business unit have access to the data (Studies, Patients, Investigators, Study Team Members) associated with their own business unit, whereas staff granted global access (normally Financial Officers and System Administrators) have access to all data.

OpenText™ Information Management solutions help life sciences organizations leverage insights from data and content to improve decision-making processes and accelerate product development. Integrate, manage, and securely exchange data across people, systems and things. Leverage information assets from R&D to commercialization. Freedom of choice with cloud-native software that can run anywhere. OpenText for life sciences accelerates the discovery process by extracting actionable insights that drive pipeline innovation. Capture and manage research papers into electronic lab notebooks with intelligent capture. Find insights with text mining. Extract knowledge trapped in the unstructured text contained in clinical trial reports, study protocols, clinical safety and efficiency findings. Find out how to intelligently analyze, classify and extract clinical trial documents to reduce the risk of costly stops and starts.

ClinAccess™ 5.1 is the next generation of our industry leading Clinical Data Management System based entirely on SAS® 9. It leads the way in simplifying clinical data management, clinical trial analysis and preparation of electronic submissions. Having your data keyed directly into SAS® data sets enhances your staff’s productivity by eliminating the time spent transfering data from Oracle/SQL into SAS. ClinAccess™ is designed expressly for ease-of-use study definition, data entry and management with features to monitor the progress and quality of ongoing clinical trials. Whether for review, analysis, or FDA submission, your data is always in SAS®and ready for analysis. The database structure is designed to support and accelerate statistical analysis and reporting. The result is less time and effort for data analysis and a shorter time to market. For reliability, auditing and security, there is no better solution than ClinAccess™.

Eliminate inefficient document workflows wasting time and money, limiting your ability to scale and attract new studies. Florence eBinders integrates all of your clinical trial systems, automates eRegulatory processes, reduces contract negotiation time, tracks study progress, and enables secure remote monitoring on the industry-standard eRegulatory, eISF, and eSource platform. Florence eBinders integrates all of your clinical trial systems, automates eRegulatory processes, reduces contract negotiation time, tracks study progress, and enables secure remote monitoring. Get your team and study set-up fast and all users transitioned with our top-ranked implementation and support teams. Most sites are fully up and running in four weeks! Reduce time spent in on-site monitor visits by turning on secure access to your monitors, as well as remote access capabilities for your team.

Maximize data quality. Ensure data quality by capturing eSource data directly during the patient visit. With built-in edit and validation checks, users capture high-quality data electronically, dramatically reducing errors and queries—and delivering data for real-time, remote monitoring. Reduce study time, cost and risk. Promoted and endorsed by the FDA to streamline and modernize clinical trials, purpose-built eSource eliminates slow, error-prone and inefficient SDV and transcription into EDC systems. Streamline site, study efficiency. Designed with site users in mind, ez-SourceDocx streamlines workflows, reduces workload and ensures protocol execution by guiding sites through properly sequenced visit procedures that guarantee all end point data and prompt quality investigator evaluation.

Medable is a software solution for researching and conducting clinical studies through a decentralized platform. The software aims to actively involve patients-contacted remotely-for obtaining the most reliable results possible. Patients can also remotely provide consent for digital examinations, and the application adapts to local languages and regulations. Right-size how your protocol is decentralized with our flexible, modular digital and DCT platform. Enable remote screening at scale, globally. Meet your studies enrollment targets faster. Develop any screening assessment. Improve consent readability with responsive layouts on web, mobile, & more. Deliver remote eConsent to patients on par with consumer digital experiences. Accommodate local regulations and languages with global flexibility. Engage patients and remove the burden of time and travel of an on-site visit. Improve patient access and engagement.

eCOA and digital technologies are the future of clinical research, effectively bridging the gap between traditional and forward-looking, patient-focused development. Rely on YPrime’s eCOA solutions not only for high quality patient data, but for a different and better user experience -- across sponsors, investigator sites and patient users. YPrime employs an agile software development approach to quickly customize and configure functions tailored to the needs of the study in 8-12 weeks. Our interactive and visual build process ensures clients have opportunities to see the system at different stages during design and development, prior to go-live. Our pre-validated, configurable authoring environment facilitates start-up timelines and post-production changes, such as protocol amendments.

Clinevo electronic Trial Master File (eTMF) is an easy-to-use electronic Trial Master File in electronic (digital content) format for organizing and storing documents, images, and other digital content of clinical trials. Clinevo electronic Trial Master File (eTMF) has an inbuilt DIA reference model and meets regulatory guidelines. Clinevo MICC Intake is a web-based tool for Medical Information Call Center (MICC) and PV users to Log, Track and Monitor Product Quality Complaints (PQCs), Medical inquiries (MIs) and Adverse Events (AEs). Clinevo Safety is a cloud-based, user-friendly, easy-to-use, regulatory-compliant end-to-end Pharmacovigilance / Drug safety system. The All-in-one system provides PV Intake, Case Processing, Regulatory Submissions / AS2 Gateway, Analytics, and Safety signals capabilities under one platform. Clinevo Website Intake is a web-based tool which can be connected to Sponsor / CRO websites to provide Consumers and Reporters a User friendly web interface.

Protocol First not only bridges physical distance and breaks down the silos in Clinical Research during the pandemic, but our solutions are also suited to “normal times”. Technology that was once nice-to-have, is now a necessity. We provide the tools to stay connected, and not just to continue your research, but accelerate it. A complete remote monitoring tool with auto-tagging capabilities. Works with any EDC, anywhere, anytime. Protocol First has focused on breaking down the silos between Sites, Sponsors, CROs and functional areas. We offer comprehensive solutions to address the many dysfunctions of Clinical Research. Protocol First is built around getting your data right and in the right places. Today and in the future that includes AI/NLP/ML. The most important aspect to AI is making sure your data has an underlying structure. The family of software at Protocol First ensures that your data from patient to FDA is able to leverage the power of data science.

RealTime-CTMS is a premier, cloud-based clinical trial management system (CTMS) purpose-built to boost efficiency and profitability for site networks and research sites. Comes with fully-integrated services that include RealTime-PAY, RealTime-TEXT, and RealTime-eDOCS (the first fully-integrated eRegulatory document management system), the solution promotes quicker and easier access to subject or study information using simple and intuitive navigation. RealTime-CTMS offers a host of other solutions that covers online document storage, appointment reminders, data collection, payment processing, among others.

HumanFirst is building the operational infrastructure to support decentralized trials and distributed care at home. HumanFirst’s workflow management software gives you and your team the tools to enable remote monitoring for your unique needs. Our timeline-based interface helps from evaluation through deployment and management. Connected sensor technologies catalogued in Atlas. Physiological and behavioral measures classified into 150+ categories. Medical conditions spanning 25+ therapeutic areas. We’ve used the open-access V3 Framework to sift through 500,000+ pieces of evidence. Identify technologies for measuring digital endpoints. Implement remote monitoring to improve patient outcomes. Share your connected product on Atlas. Our team prioritizes open-access publications and has been featured in top peer-reviewed journals. HumanFirst enables safe, effective, and equitable healthcare operations at home.

Cloudbyz Safety & Pharmacovigilance Solution is a cloud-based software solution designed to streamline the drug safety and pharmacovigilance operations for pharmaceutical and life science companies. The solution helps to automate the process of collecting, processing, analyzing and reporting adverse event data in compliance with global regulatory requirements. Cloudbyz Safety & Pharmacovigilance Solution enables companies to reduce risk, improve compliance, and enhance patient safety while accelerating drug development. Cloudbyz provides end-to-end management of the pharmacovigilance lifecycle, including adverse event processing, case management, regulatory reporting, signal detection, and risk management. With Cloudbyz, you can optimize your pharmacovigilance processes, accelerate case processing, and increase the accuracy of your safety data, while minimizing risk and ensuring compliance.

Dacima Clinical Suite is the most advanced web-based solution that combines electronic data capture (EDC), clinical data management software (CDMS), and clinical trial management software in a single platform. Built for clinical trials, epidemiological research, web randomization (IWRS), ePRO, web surveys, and patient registries, Dacima Clinical Suite helps efficiently streamline the clinical data collection process. Dacima Clinical Suite consists of three core modules: Manager (Administrator) Module, Designer Module, and Data Entry Module.