Find top products in Clinical Trial Management Systems category

The Pinnacle 21 (P21) next generation cloud suite optimizes the end-to-end clinical trials process. Increased efficiency and higher data quality are now at your fingertips! Costly manual processes are replaced by innovative technology, which empowers sponsors and CROs to automate manual processes, and speed lifesaving drugs to market faster than ever before! What can you do with Pinnacle 21? Standards management - Standardize & reuse content in our clinical metadata repository CRF design & EDC build - Design & build EDC studies in under 6 weeks External vendor data exchange - Get high quality external vendor data insights, on time! SDTM automation - Run SDTM Conversions from First Patient In and make earlier informed decisions Define.xml and Reviewer’s guide - Create define.xml up to 80% faster & automate your Reviewer’s Guide Validation - Reduce risk & ensure submission readiness P21 is a cloud-based off-the-shelf suite, so it’s ready to go when you are!

Focusing on the accuracy of your clinical data, our clinical data management experts are committed to delivering timely, accurate and high quality clinical data. Whether you need clinical data management services as a stand-alone, part of a full-service or full functional outsourcing, we can tailor customized clinical data management services to meet your needs. With one single software solution, we deliver everything from eCRF implementation to clinical database oversight in all therapeutic areas. EDC set up via IDDI’s system ID-base (powered by XClinical or Rave (powered by Medidata) From database set-up, through cleaning and reporting, to database lock, IDDI is committed to delivering timely, accurate and quality data by using regulatory-compliant data management tools.

The IQVIA Investigator Site Portal (also known as the DrugDev Portal) is a collaboration platform that gives clinical research sites the power to succeed and pharmaceutical sponsors the oversight they need to improve performance and compliance, from site selection to study close-out. With single sign-on and powerful workflow applied specifically to study operations, sponsors relieve administrative burden on sites, speed study start-up, and improve data quality. The Investigator Site Portal is composed of flexible modules and delivered in either a functional service provider (FSP) or software-as-a-service (SaaS) model: ? Site Selection ? Site Activation ? Document Exchange ? Learning Management ? Safety Notifications ? Site Engagement Learn how you can secure high-performing sites, help new sites succeed, and become a Sponsor of Choice with the IQVIA Investigator Site Portal.

Clinvigilant Electronic Trial Master File (eTMF) software revolutionizes the management of essential trial documents, offering a centralized, electronic repository for organizing, storing, and accessing trial-related documentation. With robust features for document versioning, metadata tagging, and user access controls, Clinvigilant eTMF ensures data integrity and regulatory compliance throughout the trial lifecycle. The software facilitates real-time collaboration among study stakeholders, streamlining document exchange and review processes. Advanced search and retrieval capabilities enable efficient document access, reducing the time and effort required for document management tasks. It enhances transparency, auditability, and inspection readiness, empowering sponsors and research organizations to maintain a comprehensive and compliant trial documentation system while focusing on the successful execution of clinical trials.

eCOA software enables clinical trial sponsors and sites to collect and track clinical outcome assessment data electronically. Suvoda eCOA Purpose-built with users at the center, Suvoda eCOA makes it easier and more efficient to get quality patient outcomes data for submissions and approvals. Suvoda eCOA was found to be highly usable and effective for the patient population in usability testing conducted by RWS Life Sciences. When the intuitive design and robust functionality of Suvoda eCOA is coupled with expert scientific & operational guidance and streamlined licensing & localization, sponsors and CROs can take eCOA off the critical path so trials can launch more efficiently. With Suvoda eCOA built on the same platform as IRT, manual data entry is reduced at sites, minimizing errors, increasing accuracy and data integrity, and delivering real-time visibility to patient data that can inform drug supply.

1) Independent Risk-Based Monitoring for, - Phase I-Phase IV trials - Bioequivalence Studies - Patient Based PK Studies - Clinical End-point studies - Medical Monitoring - Bio-Analytical and PK-Stat Monitoring - Toxicology/Pre-Clinical Studies 2) Independent Audit Solutions: - System Facility Audit: a. CRO Qualification/Requalification Audits b. GAP Audit - Study Audit: a. Retrospective Study Audit (Healthy/Patient) b. For-Cause Investigation Audit (Healthy/Patient) c. Pre-Inspection Readiness Audit (Healthy/Patient) d. QA Audit (Patient) e. Investigator Site Audit (Patient) f. Safety Assessment Audit (Healthy/Patient) 3) Sponsor Oversight Management: - CRO Identification - Budget Finalization, - Study Protocol, ICF, CSR, CRF Review - Project Management - Regulatory Query Resolution

IRT software is a critical technology for a clinical trial that enables clinical trial sponsors and sites to manage the patient and drug supply logistics of a trial. Suvoda IRT Our flagship product, Suvoda IRT is built to manage the most urgent moments in life-sustaining trials. From its architecture and design to its UI and reporting, Suvoda IRT empowers clinical trial professionals to take full command of the logistical complexity found in today’s patient-centric trials. Our approach, supported by industry-leading customer satisfaction and NPS scores, is built upon an extensive, ever-expanding library of IRT features and a dedicated services team that supports the unique needs of each trial throughout its duration. Suvoda IRT is built on the Suvoda Platform, a single clinical trial technology platform that delivers a seamless experience, streamlines integrations with a comprehensive API surface, and drives data integrity through a shared database across eConsent, IRT, and eCOA.

PULSE is built with pre-validated, configurable study components that enable rapid development and quicker modification to your IRT system. Building your system with PULSE will streamline complex trial randomization methods, improve your drug supply management, and simplify site, study, and subject management. The fully digital, mobile-ready system will also allow you to access patient data and outcomes in real-time.

Cenduit IRT, flexible technology, experience you can trust Power your site-based or decentralized trial with flexible Interactive Response Technology (IRT) top-ranked by industry leaders for IRT leadership, capabilities and project management support. For fifteen years, Cenduit IRT has been turning experience with complex and adaptive trials into value for partners. Cenduit IRT has deployed over 1800+ studies, at over 80,000 global sites serving 1M+ patients world-wide. Our comprehensive randomization and trial supply management capabilities meet the needs of simple to complex studies for large pharma as well as emerging biotech. In addition, our Drug Supply Centre of Excellence leads the industry in tools and services that optimize clinical supply and reduce costs for Sponsors. Cenduit IRT will help you: Accelerate study start and amendment with flexible platform builds Instate flexible randomization & treatment options Reduce clinical supply costs Improve decision-making

Join the industry’s leader in electronic source for clinical trial sites. Eliminate 90% of paper, improve data quality by 80%, and become 25% more efficient — all in real time.