Alternatives to OpenText Clinical Trial Quality Management

RegDesk is the most comprehensive AI-enabled RIMS platform for Medical Devices, Pharmaceuticals, and IVD companies. • Our proprietary Regulatory Intelligence for over 120+ countries is translated and accessible in a standard format. In addition, it provides alerts on evolving regulatory changes • Our AI-powered Application Builder allows RA teams to prepare and publish global applications in 1/10th of the time • Our Change Assessment capability helps RA teams understand the impact of the change(s) on an existing product(s) and the action required • Our Distributor Collaboration provides seamless workflow solutions to interact, communicate, and share documents with external business partners • Our Standards Management makes it easy for RA teams to search and manage not only international but also country-specific standards • Our Tracking & Reporting functionality allows teams to track regulatory projects across the globe, receive renewal notifications, and generate reports on KPIs within seconds For more information, visit our website.

Complex eClinical Solutions for EDC/ERT/eCOA significantly speeds up the start and completion of clinical trials (up to 5 days), reduces costs (up to 80% for monitoring), and increases capitalization and attractiveness (recognized by 89% customers). 96% of data science specialists say it increases the knowledge and advancements of Data Management and Data Science professionals. 94% of investigators love interfaces' usability. Strong internal competence in Data Management 365 is an important part of the Data Management 365 policy. This allows us to not only better understand the challenges faced by Data Managers and improve the MainEDC™, but also to transfer technology and best practices to our clients.

Unify quality processes with QT9's all-in-one cloud-based QMS Software Suite. QT9 QMS is a user-friendly quality management software that includes 25+ modules with unlimited scalability. Automate ISO & FDA Compliance with email alerts, To Do lists and FDA 21 CFR Part 11 Compliant Electronic Approvals. QT9 QMS enables Life Sciences, Biotechnology Companies, Medical Device Manufacturers and Pharmaceutical Companies to digitally transform operations. Get real-time status updates and visualize quality metrics up-to-the-minute. QT9 QMS comes with built-in document control, revision-level controls, corrective actions (CAPAs), Nonconforming products and more. Advance product releases with Deviation Management, Engineering Change Orders, FMEA, Inspection Management Modules Included. Go paperless & put time-consuming tasks on autopilot. QT9 QMS comes ready-to-use. Get a free product tour! Start a Free Trial. Visit QT9qms.com

Mednet is an eClinical technology company that specializes in healthcare solutions for the global life science community. Mednet's flexible, EDC-centric eClinical platform increases the efficiency of clinical research of all sizes. Mednet's comprehensive solution suite provides all the tools necessary to create and manage clinical research. It can also adapt to changing demands and requirements. Mednet has been trusted by CROs in every sector of the pharmaceutical, medical device, and biotechnology industries for almost 20 years. They provide the expertise, reliability, and innovation that they need to succeed. Mednetsolutions.com has more information.

ClinCapture's mission is to create software that saves lives. ClinCapture's technology reduces the cost of clinical trials. It streamlines data capture and protects patient privacy. Clincapture is a platform that facilitates the evaluation and development drugs, biologics and devices that have the potential to treat a wide variety of medical conditions or diseases.

The industry's best AI-powered clinical analytics platform provides actionable insights that enable your teams to manage risk, improve performance across sites, studies, and vendors. Saama's state-of-the art clintech is designed to streamline workflows, automate tedious processes, and improve collaboration across clinical operations. Saama is trusted by sponsors and CROs for data aggregation, artificial intelligence solutions, and improved decision-making. This can help to reduce drug development costs and timeframes, as well as eliminate delays. Saama can help you get on the fast track for clinical trial process innovation. Your ClinOps and medical review team will find it much easier to access all of your clinical data in one place. Data managers are often undervalued. They can now focus on the data points that are important by eliminating manual work.

Our cutting-edge platform, the Medidata Clinical Cloud, transforms clinical trial experiences for patients, sponsors and CROs. The Medidata Clinical Cloud is the only unified technology platform that focuses exclusively on clinical research. It addresses every step of the research process, from start to finish. Our platform helps medical device and life science organizations reduce development costs, minimize risks, and bring treatments and devices to market quicker. The Medidata Clinical Cloud will allow you to access the power of any product you choose for your clinical trials program. Medidata is leading the digital transformation in clinical research. Our platform, powered by artificial intelligence, machine-learning, advanced analytics, and advanced research, brings together researchers, study managers and investigators to accelerate research. Obtain regulatory-compliant, patient-friendly electronic informed consent for clinical trials.

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.

OpenText™, a leading provider of information management solutions for life sciences organizations, helps them to harness insights from data and content to improve their decision-making and accelerate product development. Integrate, manage and securely exchange data between people, systems, and things. Use information assets to drive innovation and commercialization. Cloud-native software can run anywhere, giving you freedom of choice. OpenText for life sciences accelerates discovery by delivering actionable insights that can be used to drive innovation in pipelines. Intelligent capture allows you to capture and manage research papers in electronic lab notebooks. Text mining can help you gain insights. Unstructured text in clinical trial reports, study protocol, clinical safety and efficiency findings, can be used to extract knowledge. Learn how to intelligently analyze and classify clinical trial documents and extract them to reduce the risk for costly stops and starts.

All-in-one solution for clinical trials using diamond SaaS. Data MATRIX has been working with clinical data since 2009. We analyze data and create documents that can be accepted by the Russian Ministry of Health and FDA. Our products automate clinical trials and allow users to monitor and manage the progress of their projects online. To ensure that the project runs smoothly, we adjust and validate the software before it starts. Our team has completed 180 projects for pharmaceutical and biotech firms and CROs. Six of the 10 top Big Pharma companies have seen their R&D costs drop by 15% using Data MATRIX products. Our employees are proud members of professional groups that include clinical data specialists (CDISC), medical writers (EMWA and AMWA), and data managers (ACDM.SCDM).

This company offers a variety of clinical trials management solutions suites for various CROs, Pharmaceutical and Biotech industries. BizNET-CTM is a multi-functional platform that allows a CRO (Contract Research Organization), to plan, manage, design, execute, monitor and analyze trial-related activities and data in compliance with regulatory requirements and protocol obligations. A complete solution suite that addresses all aspects of clinical research projects, from Project Management to feasibility assessment to patient or volunteer enrollment using iris recognition technology to capture clinical trial data and multi-level review to data archiving. BizNET-CTM Suite is designed to manage all documents, tasks and processes, audits, relationships, audits, training, and other information that are required throughout the life of a clinical study.

Formerly eClinicalOS IBM Clinical Development is a unified cloud-based data management platform. It offers a smarter way of collecting and managing clinical data. IBM Clinical Development is a SaaS solution that allows users to access all study data and platform functions via an intuitive and simple web interface.

Cloud-first ERP is specifically designed for life science organizations. Merit for Life Science, a cloud-first ERP, is specifically designed for biotech, pharmaceutical, and medical device manufacturers. It connects your entire organization with Dynamics 365 finance operations and finance. Mapping production requirements and resource qualifications. Monitoring vendor relationships in procurement to ensure manufacturing meets quality standards. Transparency and visibility for your life science organization to ensure safe and innovative products. We understand that every organization has its own unique needs. Get a complete overview of our services. We deliver a custom-tailored solution to meet the needs of pharma, biotech, medical device, and other companies. Using reliable, auditable accounting practices will improve your decision-making. Set financial reporting standards for acquired entities and prepare for acquisition.

All researchers from different industries can use the same environment! ResearchManager is a platform that allows researchers to access all functions and information from one place. They can also share it with others. This platform is for researchers who are ready for the future. Future where patient and data access and sharing are central. We provide support for everyone involved in research in the life sciences sector. This is done through an online platform that includes the eClinical tools EDC and CTMS & ERMS. This allows researchers to share data and facilitates research at a higher level. We are also experts in the fields of data validation, enrichment, and collection.

DrugDev Spark™, the world's first comprehensive, unified clinical operations suite, is now available. Take a look at our solutions to see why so many sponsors (9 of the top 10) and CROs (4 of the top 5), trust DrugDev technology.

Within3 is the leader in insight management for life science teams. Our insights management platform helps identify the right people, engage them and deliver answers that enable informed, agile decision-making. Our platform was created to address the life science insight gap. Companies often base decisions on outdated or incomplete data, which can lead to huge losses in time and money. Within3's insight management platform closes the gap in product development. It can be used at all stages of the product development process, including planning, recruiting, understanding, and analysis. Within3 is trusted by the world's leading pharmaceutical companies and medical device companies to identify key professionals, engage audiences in focused discussions, gain a 360-degree view on scientific and market signals.

Our platform has decades of industry experience and is the only one specifically designed for life science companies. R&D Logic lets you and your team view plans and actuals from multiple perspectives so that you can always see how your business is performing. R&D Logic offers a personal service that will take care of your needs, from implementation through training to ongoing support and expert consulting. We manage the backend so that your data is secure and private so that you can concentrate on running your business. We take the time to get to know your needs and create the right combination products and logic for your business. R&D Logic's platform grows with you. As your needs change, you can add, remove, and modify features and business rules. No matter how small or large they are, we always put our customers first.

Omda MedSciNet improves the quality, utility and management of medical information from collection to analysis. This secure, standardized software allows clinical researchers and other professionals from medicine and academia to easily gather and analyze well managed medical data. The Omda team is specialized in designing and building clinical studies and custom database applications for medical research. The Omda MedSciNet platform is a highly customizable, feature-rich and reliable online environment that hosts and manages sophisticated study and trial systems. Omda MedSciNet is a proven platform that has hosted studies and clinical trial systems of all sizes and scopes for over 20 years. The standard implementation includes all the components needed to establish fully functional clinical trials or studies.

Mosio allows research teams to improve subject adhesion, communications, data collection, and communication on mobile's most popular channel, text messaging. Our software helps research teams communicate more efficiently with participants by delivering interactive elements to mobile phones and messaging automation. WHO CAN WE HELP? + Clinical Trial Sponsors (Pharma & Biotech) + Cancer Centers and Clinical Research Organizations + NIH-Funded Studies + Public Health Agencies + Clinical Trial Managers/Directors and Clinical Operations Managers/Directors. Clinical Project Managers. Principal Investigators. Clinical Research (Study). Coordinators. All research staff who regularly communicate with study participants. BENEFITS + Interactive medication reminders and medication compliance alerts + Automate data collection. + Increase engagement and adherence. + Get SMS appointment reminders to fix your no-show problem. + Increase retention with automated check ins

Amazon Comprehend is a HIPAA-eligible, natural language processing (NLP), service that uses machine-learning to extract health data form medical text. No machine learning experience is necessary. Today, a lot of health data is found in free-form medical texts like doctor's notes, clinical trials reports, and patient records. Manually extracting data can be time-consuming and automated rule-based attempts at extracting data won't capture the whole story because they don't take context into consideration. The data is not usable for large-scale analytics that will help improve the healthcare and life sciences industry, patient outcomes, and increase efficiencies.

TCS ADD platform speeds up speed-to-market for the pharmaceutical industry across all clinical R&D value chains and makes clinical trials more efficient and safer. TCS ADD facilitates digital ecosystems, simplifies data complexity, and provides patients faster access to effective drugs. The platform is powered with TCS Decision FabricTM cognitive artificial intelligence engine, smart analytics and IoT which provides superior business value for the pharmaceutical industry. The next-generation, end-to-end metadata-driven solution for managing industry and sponsor clinical standards. Data science-driven platform that uses AI & ML technologies to speed up study start-up, targeted interventions, and quicker decisions. This solution digitizes the entire clinical supply management process, while placing the patient at the center. This increases patient safety and overall efficacy.

Combining the multiomic data and medical history of an individual to deliver more personalized healthcare. Use purpose-built databases to support large-scale analyses and collaborative research across populations. Accelerate your research with scalable workflows, integrated computation tools and integrated computing. Protect patient privacy by ensuring HIPAA compliance and using built-in data access, logging and logging. AWS HealthOmics enables healthcare and life sciences organizations and their software partner to store, query and analyze genomic, transcriptionomic, or other omics data, and then generate insights using that data. Store and analyze omics for hundreds of thousands patients to understand the relationship between omics variation and phenotypes in a population. Create reproducible and traceable workflows for clinical multiomics to reduce turnaround time and increase productivity. Integrate multiomic analyses into clinical trials to test out new drug candidates.

In today's pharmaceutical manufacturing environment, it can be difficult to maintain consistent product quality and quality processes. To meet regulatory requirements, industries like the Pharmaceutical, Biotech and Life Sciences must maintain Good Manufacturing Practices (GMP). You must not only meet GMP requirements, but you must also be capable of proving it.

LexisNexis®, MarketView™, provides medical claims-based information to healthcare payers and providers, life science companies, and health IT organizations throughout the United States. MarketView provides actionable insights that help businesses remain competitive. It allows them to see valuable insights and visualize ways to transform their business. MarketView is available to all life sciences companies, health plans, health systems, and vendors. It can transform key business work streams such as marketing, sales and strategic planning, physician outreach, physician relations, network optimization, market research, pricing, contracting and recruitment. To remain competitive, your business needs the most actionable insight. It can be difficult to pinpoint the right areas of focus if the picture isn't clear. MarketView provides insights into areas such as physician alignment strategies, referral patterns, physician referral patterns, quality of clinically integrated network, patient volumes, and more.

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.

SANeForce offers a comprehensive CRM and sales force automation solution, primarily tailored for the pharmaceutical, healthcare and life sciences industries. SANeForce is designed to increase the productivity of marketing and sales teams. It offers features such as real-time order tracking, expense tracking, stock control, and territory administration. The platform supports medical representative reporting, allowing field sales personnel log visits, capture doctor interaction, and manage appointment directly from their mobile device. SANeForce's data-driven insights, analytics, and customer engagement strategies help organizations track performance, streamline their processes, and optimize their customer engagement strategies. The solution also includes features for compliance, making it an ideal choice for highly-regulated sectors that require meticulous records and adherence to standards.

Protocol Manager assists clinical operations in managing global trials for drugs, biologics, vaccines and other devices at all stages of development. Protocol Manager will help you comply with FDA's 21 CFR Part 11 regulations by ensuring that your company has implemented the right Standard Operating Procedures. Protocol Manager supports Web Services technology for seamless, automatic integration to many popular EDC or IVRS products. Integration is possible via an export/import method for systems that do not support Web Services. A database and tracking tool that can manage multiple trial information and metrics.

Enterprise Quality Management Software in cloud for life sciences. Technology plays a crucial role in ensuring that QA is aware of any issues as they arise in today's complex operational environment. You can gain insight into your quality management system's performance and the current state in your operation to be more proactive and reduce risk. Montrium's Enterprise Quality Management system (EQMS), was designed to help life science companies tackle the content management challenges they face head-on. Each module of the SharePoint QMS can be used separately or as part of a fully integrated quality management platform. These modules can be used on-premise or in a cloud environment. These modules are ideal for pharmaceutical companies, contract manufacturers, and medical device companies. Built to comply with GMP/GCP requirements.

Data management is crucial to the success and efficiency of your clinical research. Despite being complex, Quanta View, an e-CRF, makes it possible to control the processing of your data. Quanta View includes elements such as monitoring, follow up of inclusions, and project management. The application will be there to help you in all aspects of your clinical research. It is accessible via the internet and responsive. It adapts to all media (tablet, laptop, etc.). Quanta view is designed for the pharmaceutical, medical device, and cosmetic industries.

THINQ is a thought-leader in compliance for the Life Sciences sector. They provide compliance solutions to a wide range of pharmaceutical, biotechnology, and medical device companies. THINQ has a special expertise regarding validation and is leading the change in how validation is managed within Life Sciences companies. THINQ provides comprehensive compliance program management and development--powerful, market-proven solutions that are custom-tailored to our enterprise clients.

BaseCase, Certara's leading value communication platform and market access platform, is available from Certara. Its suite of SaaS products allows pharmaceutical, medical device, or diagnostics companies to better engage with payers, healthcare professionals, as well as other key stakeholders. The interactive mobile apps allow them to create personalized value stories and use mobile apps to do so. BaseCase is unique in that it combines 'no code' content creation with integrated value communication on one platform. This has transformed the way life science companies think about product and how it's communicated. The life sciences industry's complete value communication platform. Integrated content creation and KAM enabledment allow for unparalleled flexibility and speed. You can create cutting-edge mobile content quickly and easily without programming. This will dramatically reduce your workload as well as your costs. Integrated content creation and KAM support on one platform will help you get to market faster.

Fusion is Axiom’s proprietary, cost-effective and easy-to-use eClinical solution. It is aimed at small to medium-sized device, pharma and biotech companies. Axiom's Fusion eClinical Suite allows you to add-on any Modules that meet your study needs. Are you running a small study? You can choose the base configuration with EDC and DM, as well as AE/SAE tracking. Are you looking for something more? To make managing your study easier, you can include powerful Modules like Inventory Tracking, RTSM, Safety Management. You can save time by electronically capturing your study data - even offline! Once you have an internet connection, your data will sync to your Fusion databases. Real-time records available for subject screening activities. Fusion Safety Database allows you to manage pharmacovigilance events.

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.

ePharmaSolutions is building something new. We are not a high tech company. We are an idea-driven company whose thinking is deeply rooted in technology but not limited by it. We provide solutions to improve the management, activation, and training of clinical trial sites. We offer technology-enabled solutions that "un-complicate" clinical trial management. ePharmaSolutions is a leader in e-clinical solutions. Our solutions improve the selection, training, activation, and management of clinical trial sites. We bring new thinking to old problems and provide technology-enabled solutions to enable sponsors, contract research agencies, and investigator sites to "uncomplicate" clinical trial management.

Affytrac is our secure EHS Software for the Life Science Industry. It is currently used by biotechnology, pharmaceutical, and medical device companies around the globe. You don't need to install any software. Our streamlined setup process makes it easy to have your EHS program automatically set up, tuned and available at all times. Affytrac is simple and intuitive, yet powerful and fully-featured. It does not have any extra complexity. Task Management allows you to define your organization's compliance and safety tasks. Affytrac tracks progress and notifies staff by assigning tasks to the appropriate personnel. Track and document Corrective Actions resulting from accidents, incidents, safety committees and regulatory inspections.

Cortellis™, a suite of life science intelligence software solutions, reveals hidden insights in data. This allows you to make better informed decisions throughout the R&D process. We have taken out the tedious work of finding, integrating and analysing data so that you can concentrate on the crucial decisions required to bring your products to market quicker. Cortellis provides unique data analysis that is rich in domain knowledge, industry insight, and therapeutic expertise. This allows you to unlock hidden insights that will allow you to make data-driven decisions that drive innovation. With the most comprehensive and deepest intelligence, you can get precise and actionable answers to specific questions throughout the R&D process. Cortellis is an indispensable part your daily work flow.

eClinical Solutions assists life sciences organizations around world in their clinical development initiatives by providing expert data services and the elluminate®, Clinical Data Cloud -- the foundation for digital trials. elluminate, which is used by more than 100 biopharmaceutical companies worldwide, is a clinical data platform that was purpose-built to accelerate digitization efforts to manage the exponential increase in clinical data volume, variety and velocity. Gartner's 2022 Hype cycle for Life Science Clinical Development shows that life science companies are continuing to scale digital capabilities. The adoption of advanced analytics, hyperautomation, AI, and hyperautomation is becoming more mainstream. With elluminate's automated pipeline and scalable infrastructure, organizations can keep up with modern clinical trials and deliver business value across all clinical development functions.

CSAM Studies (previously MedSciNet Studies), is an online environment that allows for secure and highly customizable hosting of clinical trials and studies of all sizes. It has a 20-year history of hosting successful clinical trials and research of all types. Studies is a web-based platform for medical research. It offers a sophisticated online application package that allows you to host, maintain, and monitor projects of any size or complexity. The standard Studies solution from CSAM MedSciNet includes all the components necessary to set up a clinical trial or study. The benchmark solution supports rich and interactive data entry forms, flexible workflow structures, advanced data validation, analysis and exporting capabilities.

ICyte is used by life science organizations of all sizes and complexity to facilitate pharma market access and commercialization. ICyte offers biotech and pharma companies world-class channel, patient and pricing data aggregation, contracts, pricing managed services and gross-to-net forecasting, accrual systems, expert launch and pricing transparency solutions, and pricing managed service contracts. ICyte helps pharmaceutical and biotech companies increase market access by quickly transforming channel, payer, complex transaction and patient data into actionable insights. ICyte also supports analytics-as-a-service, which allows common models and metrics to be deployed as a centralized service across applications, data, and analytics uses. The platform includes key performance indicators (KPIs), which are specific to Life Sciences companies. Also included are advanced analytics such as forecasting, scenario modeling, and a machine-learning-powered recommendation engine.

Our Smart Protocol system is designed to automate and add intelligence to clinical trials design with AI. Smart Protocol is revolutionizing how research teams design clinical trials. Humans can no longer physically digest all the information necessary to make a decision in today's digital age. A majority of companies have valuable data that isn't being used. Documents are stored in repositories without any line-of-sight. Companies in life science are making costly and difficult decisions based on incomplete information. We want to transform companies like yours' from a document-driven environment to one that is data-driven. We aim to reimagine how clinical trials are planned and researched by removing barriers between data and end users. We do this by mining huge amounts of trial-related documents both from customers and the public domain.

Loftware Prisym 360 offers innovative content management features that incorporate industry best practices. It is specifically designed to meet the complex regulatory requirements for clinical supplies labeling. Many clinical labeling teams use English MLT/CLT variants for defining the content of booklets and labels for clinical trials. The number of countries in each study increases and each country has specific regulatory content, phrases, and language requirements. Therefore, the manual process of designing booklets and printing them takes longer and is more risky. Prisym 360's CLT/MLT solution prompts users to provide study information. Then, it automatically generates MLT, CLT, and booklet designs based on its knowledge about content and design requirements. This reduces the time it takes to create a clinical label or booklet, reduces errors and ensures compliance with regulatory requirements.

Deep 6 AI disrupts clinical trial enrollment by changing the way researchers identify eligible patient. DEEP 6 AI uses artificial intelligence and natural-language processing to mine structured and unstructed patient data. This allows DEEP 6 AI to find more patients that are better-matched for trials in a matter of minutes, rather than months. Deep 6 AI is used by some of the most prestigious health systems, pharmaceutical companies, and CROs around the globe. This makes the DEEP 6 platform an essential step in their clinical research workflow, greatly speeding up patients' access to clinical trial. Deep 6 AI locates more patients for clinical trials than it takes months. This allows people to receive life-saving treatments much faster. Deep 6 AI analyzes both structured data such as ICD-10 codes and unstructured clinical information, including doctor's notes and pathology reports. It also provides free-text access to important medical data that cannot be searched easily.

Software that allows you to track and organize Quality Risk Management information online. It uses web-based technology to trace Quality information to the specific risk it poses to the patient or drug product. Why Choose Us? CINCO is a risk-based software for quality management in the Life Sciences Industry. It allows transparent quality decisions by allowing for paperless traceability of all critical quality aspects of a drug or medical device. Why Risk Management? Quality Risk Management is a method that identifies and mitigates the risks associated with a drug or medical device manufacturing operation. Most regulatory agencies require it. The paper-based approach used by the Life Sciences Industry is ineffective in managing significant and valuable risk data. It is susceptible to errors, introduces too many friction to users, and does not add any value to the operations. Access to the most critical information about the product on-demand

Clinevo electronic trial master file (eTMF), is an electronic Trial Master File in electronic format (digital content). It can be used to organize and store documents, images and other digital content for clinical trials. Clinevo electronic Trial Master File eTMF has an inbuilt DIA reference model that meets regulatory guidelines.

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.

AI-powered medical image processing meets advanced clinical data automation. UNITY, available as a web-based SaaS solution or on-premises solution, is trusted by major medical equipment manufacturers and hospitals around the world to collect complete, compliant, and consistent data. The integrated modules for PROM and eCRF streamline key data collection to enable faster, more cost-efficient trials. RAYLYTIC’s Imaging Core Lab has decades of experience in high-precision, automated evaluation of musculoskeletal device performance and morphology in spine, hip and knee.

Revolutionize your Life Sciences processes. You can dramatically improve the quality, control, and efficiency of your products and processes. Our fully compliant platform is pre-validated according GAMP5. This ensures inspection readiness at all time. You have complete control over all documents and processes. You can also customize workflows and automate when possible. You can enjoy uninterrupted workflows and full traceability with seamlessly connected and integrated modules. Our dedicated team is available to answer any questions you may have. Only the best Scilife experience is possible! Our Scilife platform automates, automates and organizes all processes in your industry space, no matter if you're in Medical Devices or Pharma & Biotech or ATMP. Click below to see which Scilife modules are available for your industry's unique lifecycle stages.

Platforce CRM, a cloud-based CRM that automates industry-specific business processes and improves customer engagement, is a closed-loop marketing and customer relationship management solution for pharmaceutical and life sciences companies. The system allows you to manage all aspects of marketing and sales activities, from the marketing cycle creation through territories assignment, databases creation, calls carrying, and KPI analysis.

ComplianceWire, a cloud-based, Part 11 compliant learning management system (LMS), was developed by UL Compliance to Performance. ComplianceWire is a workforce training system for pharmaceutical, biologics and medical device companies. It facilitates the management and proficiency of learners, as well as compliance status. ComplianceWire's unique role-based approach to compliance qualification and performance management allows users to meet stringent regulatory requirements while seamlessly managing the most difficult training assignments.

Providers and life sciences companies can use the platform to securely access cloud-based healthcare data and longitudinal EHR data. A collection of SaaS applications that can be used to manage the population, measure performance, and engage patients and providers. Allows healthcare systems to combine, link and combine data from hundreds different sources within their enterprise and clinically integrated network. It allows care and quality program developers to search and browse populations around diagnoses, treatment, outcomes and demographics. It quickly identifies target populations, allowing you to make better decisions regarding risk-stratified care management. A framework that allows you to correlate billions of clinical, financial and operational events into benchmarks and scorecards that can be used for comparison.