ClinCapture Alternatives

Create, in a few hours, an eCRF that is as easy to use as a paper one, and avoid the biggest headaches in data collection in Pre-authorisation and Post-authorisation studies of your medical device. Incorporate an EDC that is highly flexible when creating the eCRF, this will allow you to meet the needs of any kind of study. Save tons of time in the management and monitoring of the study with the management and monitoring tools included in the EDC. Use a validated system with all the security guarantees that give trust to the sponsor and allow the collection of quality data. Don’t wait until the analysis phase to discover mistakes in the data or you will end up chasing down investigators to correct them. Prevent the process of creation of an eCRF from being long and complex.

OpenClinica is a premier provider of clinical data management software solutions. Offering powerful tools for efficient, compliant clinical trials, OpenClinica helps maximize the security, reliability, and compliance of every clinical research. Core products include OpenClinica Enterprise, OpenClinica Participate (helps capture data directly from study participants), and OpenClinica Randomize.

Medrio is on a mission to ease complexity in today’s hybrid, decentralized, and site-based clinical trials by delivering a flexible suite of eClinical technologies and services, including EDC, eCOA, ePRO, eConsent, Direct Data Capture, and Randomization and Trial Supply Management (RTSM). Trusted by CROs, sponsors, and sites across all therapeutic areas and trial phases from study startup and feasibility to post-market approval, we are industry-recognized for delivering eClinical software with intuitive interfaces and time-saving “drag and drop” configurations as well as high-touch customer engagement, onboarding, and support services. Medrio’s innovative software, as well as the robust and flexible training and support resources we provide our customers, have earned us a 98% customer satisfaction rating.

Complex eClinical Solution for EDC/ERT/eCOA that significantly speeds up the start of clinical trials (up to 5 days), saves budget (up to 80% for monitoring), increases the capitalization and attractiveness of your company (noted by 89% of customers). Increases the knowledge and advancement of Data Management and Data Science professionals (noted by 96% of specialists). 94% of investigators like the usability of interfaces. An important part of Data Management 365 policy is to have strong internal competence in Clinical Data Management and Data Science. This allows our company not only to deeper understand the challenges that Data Managers face in their work and make the MainEDC™platform better using the online feedback but also to provide the transfer of technology and best practices to our Clients.

With over 20 years of experience in both software edition and clinical research sectors, Arone provides clinical research organizations with a complete suite of tools for patient data entry and management. Our solutions are turnkey and our team provides you with personalized support for the proper conduct of your projects and studies. Collect and manage patient data in a single tool. Arone manages the randomization of patients by randomly assigning study participants a type of treatment in order to remove bias in the study. Empower participants of clinical trials for their daily data entry. Benefit from a customized support for your projects.

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.

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.

AI-powered medical image analysis meets advanced clinical data process automation. Available as web-based SaaS or an on-premise solution, UNITY is trusted worldwide by major medical technology manufacturers and hospitals to collect complete, consistent, and compliant data. The integrated modules for PROM, eCRF, and medical image analysis streamline key data collection activities to enable faster, cost-efficient trials. RAYLYTIC's Imaging Core Lab possesses decades of experience in the high-precision, automated, independent evaluation of musculoskeletal morphology and device performance in spine, hip, and knee to offer clients unparalleled analytic and operational support.

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.

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.

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.

Mednet is a healthcare technology company specializing in eClinical solutions designed for the global life sciences community. Mednet’s flexible, electronic data capture (EDC)-centric eClinical platform improves the efficiency of clinical studies of all types and sizes. Beyond simply EDC, Mednet’s comprehensive solution set provides the tools required to build and manage all types of clinical research, while adapting to evolving demands and requirements. Pharmaceutical, medical device, biotechnology and Contract Research Organizations (CROs) around the world have trusted Mednet for nearly 20 years to deliver the technology innovation, experience and reliability they need for success. For more information, visit mednetsolutions.com.

All-in-one diamond SaaS solution for clinical trials. Data MATRIX team has been working with clinical data since 2009. We process data, analyze it and develop documents to be accepted by the Russian Ministry of Health, FDA, and EMA. Our products automate the processes of clinical trials, and users manage and monitor its progress online. We adjust and validate our software before the project starts and take into account all aspects of the project in order to do it in the best way. Our team has conducted 180 projects for pharmaceutical and biotech companies and CROs. With Data MATRIX products, 6 out of 10 TOP Big Pharma companies reduced their R&D costs by 15%. Our employees are proud to be members of professional communities which unite clinical data specialists (CDISC), data managers (ACDM, SCDM), biostatisticians (ISBC), and medical writers (EMWA, AMWA).

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.

DFnet is a healthcare technology company that provides eClinical solutions, including electronic data capture, eSource, and data management services. We bring more flexibility, better data quality, and greater efficiency to clinical trials everywhere in the world. Collect data from any source – paper crfs, EDC and other electronic sources, online/offline tablet and ePRO entries. Install within your controlled premises or allow us to host in our secure cloud environment. Accelerate SDV and RBM processes with advanced optical recognition that shaves time off manual data entry. Built for maximum flexibility of multi-center studies. Web-based data capture from any source is instantly available in a centralized real-time platform.

Compared to other EDC solutions on the market from MediData, DataTrack, Omnicomm and others, TrialStat is the most all-encompassing suite of study management tools that can be seamlessly connected to external data sources such as EMR, wearables, and other clinical and non-clinical data and information sources. TrialStat offers a fully unified platform suitable for all phases and types of trials. Our single-sign-on, multi-tenant EDC suite includes modules for Randomization, Adjudication, Coding, Safety, Patient Diaries/ePRO, Vendor Neutral Imaging Archive, a robust Reporting and Analytics Portal and custom Machine Learning programs. With a focus on data analytics, TrialStat offers real-time reporting, data extracts on demand, and analytics across a single study, a program, or your entire research portfolio – providing all stakeholders relevant, customized, timely insight into all aspects of study data and highlighting areas of risk or potential delays.

Castor is an Electronic Data Capture system for medical research. Built by researchers, for researchers, Castor is an easy to use, complete, and affordable solution that offers all the capabilities researchers expect from an EDC, and more. Top features include self service eCFR creation (form building), randomization, ePro (patient surveys), monitoring, easy import and export of data, EHR data importer (HL7 FHIR based), audit trails, user management, and much more.

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.

Entrypoint is a complete system for creating, deploying, and administering custom data entry applications, providing data entry and system administration access anywhere you are. Entrypoint is a suite of easy-to-use tools which allow users to design, deploy, and use a wide variety of custom data entry applications with built-in validation, editing, and export options. Entrypoint has many built-in attributes that make adding advanced features such as range checks and table lookups a simple operation. Collecting information on paper forms to re-enter it later into a computer system is a double-entry process that adds the risk of transcription errors and takes extra time. Entering data directly into a database via electronic forms eliminates the paper step. Switching to electronic data capture becomes an even more compelling choice for organizations who face an increase in data volume and rising costs.

Flex Databases is an innovative, unified and compliant eClinical platform, providing software solutions for clinical trials: CRO and pharmaceutical companies. Our system consists of : - Clinical Trial Management System, - electronic Trial Master File - Project Management & Budgeting solution, specifically tailored for clinical trials industry - Pharmacovigilance system - Learning Management System Our unique experience and qualified team of over 100 professionals who possess a deep understanding of the clinical trial process made it possible to create a flexible platform.

DSG, Inc. is a leading global eClinical provider with a fully unified suite of innovative technology solutions and data management services for the global clinical research community. DSG's eClinical software platform provides competitive advantage that is cost-effective with on-time project delivery. DSG solutions have been used in thousands of clinical trials around the globe with our award-winning eCaseLink™ platform and eCaseLink Designer for enterprise licensing. Founded in 1992, the company is proud to be recognized as the first provider of a fully integrated EDC and IRT Randomization and Trial Supply Management system with the SCDM Data Driven Innovation Award.

At Calyx, we know that the success of your clinical development program comes down to data. Which makes the effectiveness of your electronic data collection (EDC) system key. Used in over 2,600 worldwide clinical trials, Calyx EDC streamlines clinical trial data collection and reporting—in one easy-to-use platform. Don’t trust your important data to just anyone. Contact us to learn how Calyx can propel your program’s success. Calyx EDC gives you the flexibility to easily plan, design, and conduct studies, regardless of their complexity. With features that help reduce costs, improve site visibility, and drive efficiency, Calyx EDC keeps your trial on track.

Secure and user friendly cloud-based EDC platform for managing clinical trials and studies of all sizes and complexities: ePRO, eConsent, eCOA, eSource, PROMs, PREMs, functional health assessments and participant education/engagement.

We know that data management is essential to the success of your clinical studies. Although these remain very complex, it is currently possible for you to ensure the processing of your data thanks to Quanta View, the e-CRF which is perfected according to your expectations. Quanta view has elements such as the creation of eCRF, monitoring, follow-up of inclusions, project management. The application will accompany you from A to Z in your clinical research. Accessible on the internet and responsive, it adapts to all types of media (tablet, computer, etc.) Quanta view is intended for pharmaceutical industries, medical device industries, cosmetic industries, etc. Offer you a comprehensive clinical research service hub, flexible and adapted to a high-performance, demanding and constantly evolving ecosystem.

Streamline your clinical studies with Clinvigilant, your global cost-effective eClinical tools provider for CROs, Pharma, Biotech, Nutraceuticals and Academic organizations in clinical and post-marketing stages. Most of our clients choose and stay with us for thanks to our: ♦ Fast EDC set-up (less than 4 weeks). ♦ Cost-effectiveness. ♦ 3rd party integrations (including legacy systems). Our cloud-based suite (Microsoft Azure) is HIPAA, ICH-GCP, GDPR & 21 CFR part 11 compliant and we have been audited by the FDA, EMA and MHRA. The Clinvigilant eClinical suite includes: EDC, CTMS, eCRF, eTMF, eSource, IWRS, ePRO, eConsent and eCOA. Just pick the tools that you need and we will integrate them within your existing software ecosystem. How simple and user-friendly is it? Ask for a demo to find out! Clinvigilant💊, your one-stop 🌐solutions provider for ☁️clinical trials. Enquiries > bd (at) clinvigilant.com

Fusion is Axiom’s proprietary easy-to-use and cost-effective eClinical solution that is focused on small to medium sized device, pharma, and biotech companies. With Axiom’s Fusion eClinical Suite, you can add-on any Modules to meet your study requirements. Running a small study? Just choose the base configuration with EDC, DM and AE/SAE Tracking. Running something more complex? Include powerful Modules such as Inventory Tracking, RTSM, Safety Management to make the management of your study so much easier. Save time by capturing your study data electronically – even when offline! Data syncs to your Fusion databases once an internet connection is established. Access real-time records for Subject screening activities. Safety Database for the management of pharmacovigilance events directly within Fusion.

eCOA by EvidentIQ optimizes real-time, direct-from-patient data collection by offering a simple and intuitive interface providing advanced patient assessments to enhance the patient experience and improve data quality. Customers can benefit from an end-to-end comprehensive eCOA package or create value by selecting from the various elements meeting specific requirements. Book a demo with our team of experts and see how you can improve your study ROI. eCOA by EvidentIQ brings data science services and technology together. Customers can benefit from an end-to-end comprehensive eCOA package or create value by selecting various elements meeting specific requirements. The solution can be used stand-alone as it is independent of any specific eClinical technologies such as EDC systems, but it can be integrated in any existing eClinical software landscape. It has been created to collect any patient/clinician/observer reported outcome data in a streamlined, compliant and efficient way.

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.

As a Data Management provider we offer data management and statistical analysis planning and model development with applicable CRF design. All the appropriate documentation is provided by us according to FDA and other regulations. Previous experience has shown us that putting more effort into the planning phase will give a better, faster and efficient result in the end-phase of the trial. Our databases are generated by experienced data managers who have worked with several eCRF-s and already know the critical parts of the electronic data capture system design and data collection. This allows the eCRF to be built in a short period of time. eCRF validation and testing is compulsory part of the design and is dealt by different personnel in order to receive a hundred-percent elaborated eCRF.

If you are a researcher doing clinical research you know that data collection can be a huge time-drainer and mess, especially when using paper forms. That's why we created Teamscope: to help you easily collect research data, keep it secure and instantly analyse it. We want to help you worry less over your research data and have more time for the things you love. With Teamscope you can switch from collecting data on paper to electronically in no time. Use our online form builder to customise your survey forms with 11 different field types. Skip logic is a feature that makes it possible to hide or show fields depending on what values are entered. With skip logic you can create alternative paths or branches within a survey. The conditions that create each path can be as complex as you want to make them and our experts are ready to help you build even the most complex form on Teamscope.

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.

Actionable insights, driven by the industry's #1 AI-powered clinical analytics platform, enable your teams to manage risk and improve performance across studies, systems, sites, and vendors. State-of-the-art clintech from Saama is designed to streamline your workflows, automate time-consuming processes, and improve collaboration across clinical operations, medical review, data management, biostatistics, and pharmacovigilance. Sponsors and CROs rely on Saama for data aggregation and artificial intelligence solutions that lead to better decision-making, eliminate delays, and significantly shrink drug development costs and timelines. Saama can put you on the fast track to clinical trial process innovation. When all your clinical data is in one place and updated in real time, life’s much easier for your ClinOps and medical review teams. Data Managers have been underappreciated for too long. Eliminate manual work so they can pay attention to the data points that matter.

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.

Jump-start your project by choosing one of our applications as your foundation to configure and modify. Can’t find what you’re looking for? Create a new app from scratch using our intuitive visual designer. With powerful pre-built components at your disposal, you can define your forms, build your workflows, and design your app with a user-friendly drag-&-drop interface. No coding required! Build your study using an intuitive visual designer and drag-&-drop interface. Define the structure of your database according to the type of study and data you need to collect. Aggregate and review your data through specialized screens. Check for discrepancies, manage incomplete forms, track follow-ups and more. Rediscover your database and organize it into manageable units according to the criteria you choose. Create filters in natural language and use saved datasets for reporting, workflow planning, patient management, data analysis and more.

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.

Select Curebase to run your next study and experience greater diversity, faster enrollment, and better retention. Our cutting edge approach allows patients to participate at home and with community physicians leading to faster, cost effective, and diverse studies. Curebase has a unique combination of in-house virtual CRCs paired with a global network of virtual PIs working together with community doctors to bring studies to patients anywhere. Most patients don't live near a traditional research site. Our trials move the research into patients' homes and real-world medical settings, such as community doctors' offices. Curebase infectious disease trials successfully enroll patients utilizing a new kind of model that meets patients where they are through community healthcare and virtual settings.

TrialPoint™ electronic data capture (EDC) is easy to configure, easy to use, and the coordinators love it. Our data managers are experts in converting clinical protocols into geek-speak (metadata dictionaries for those in the know) and will configure TrialPoint™ to work for you, not against you. The system can accept any randomization string, media upload, or coding dictionary. It can even blind users to treatment assignments. To promote time-sensitive data collection. the system will prospectively calculate visit windows and send out alerts and reminders keeping the team focused and on task. Nowadays, patient-reported health outcomes and quality of life questionnaires are included in most trial designs and are responsible for many protocol compliance issues. Take a look at TrialPoint’s electronic patient-reported outcomes (ePRO) module which can be configured to fit any quality of life questionnaire or patient diary.

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.

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.

A Clinical Data Management System (CDMS), Clinical Trial Management System (CTMS) and Electronic Data Capture System (EDC) all in one powerful, integrated solution. All your study information can be at your fingertips with our innovative, flexible and compliant Clinical Trial Software System. Our servers or yours. Clindex® can be installed on your servers or it is available on the Fortress Medical Cloud (SaaS – Software as a Service). Cloud access is available world-wide and your data is securely stored at a SOC 3 certified data center. You can build, we can build. Clindex® provides all the tools you need to develop your own study database. Our quick start manuals and help documentation walk you through the process, step by step. Or our Clindex services team can develop a study for you.

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.

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.

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.

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.

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.

GoResearch™ is a fully validated, innovative internet platform for electronic data capture(EDC) created by 2KMM for research projects such as clinical/observational studies andpatients registries. It offers a wide range of features supporting such projects invarious areas such as: configuration of the information flow and the Adverse Events management procedures (including automatic e-mail notifications to safety departments), random allocation to a treatment arm through the built-in randomization module, data collection with the use of individually customized case report forms (eCRF) to meet the requirements of each study, and ePRO, eSource and mHealth data integration through dedicated mobile and/or web applications or flexible application programming interface (API).

Continually pushing the next level in modern concepts and already outpacing the boundaries of the new normal, Encapsia is already revitalising clinical trial with the most flexible, efficient and innovative system available. Responsive image Unlike traditional systems, Encapsia is built in the era of smart phones, leveraging modern concepts to revitalise clinical trials. In addition to traditional EDC, we offer Encapsia eSource for direct data capture (DDC) in the same system that brings you medical coding, third party data Loads, as well as industry leading data visualisations; all driven from one single configuration. Encapsia is the most innovative & powerful system available bringing you a complete solution to collect and manage clinical trial data. The concept of live is real - with all data available as soon as entered to give you up to the minute insights into trial progress that can help inform your management decisions, saving money and time whilst increasing patient safety.

Protocol Manager helps clinical operations manage global trials of drugs, devices, biologics, and vaccines in all phases of development. When the appropriate Standard Operating Procedures (SOPs) are implemented in your company, Protocol Manager can help you be compliant with the FDA’s 21 CFR part 11 regulations. Protocol Manager supports Web Services technology to provide seamless, automatic integration with many popular EDC and IVRS products. For systems not supporting Web Services, integration is supported via an export/import mechanism. A robust tracking tool and database designed to manage myriad trial information and metrics.

Open HealthHub is the world’s first end-to-end encrypted communication hub between doctor and patient. In everything we do, security & privacy of your data are paramount. We comply with the General Data Protection Regulation (GDPR). We call this secure by design. The Open HealthHub is the way for medical professionals and researchers to easily, securely and efficiently collect patient data via a mobile app or medical devices. Our integration technology based on APIs and international standards for medical data such as FHIR and SNOMED CT allows for easy integration of the Hub within the infrastructure of any hospital or medical clinic.

Cost-effective data capture. LifeSphere EDC delivers sponsors and CROs a cost-effective way to capture, manage and report clinical research data regardless of trial phase and complexity. Combine disparate systems into a single unified database eliminating the need for costly integrations and reconciliation. Captures clinical data direct from site, eliminating the need for paper CRF and data entry. Reduce study development times and create seamless implementation of changes to live studies. Unified with the LifeSphere Clinical cloud platform – including LifeSphere eTMF and LifeSphere EDC – to seamlessly connect operations with data management. Single sign-on functionality provides simple access to a suite of applications, while open architecture ensures rapid integration with third party applications via API.