Partnerships Make Us Even Stronger
FMD K&L is a Medidata Services Partner.
Through this world‐class partnership, we are able to provide services that leverage Medidata's innovative solutions to optimize Sponsors' clinical trials. FMD K&L offers comprehensive clinical trial design in conjunction with Medidata Rave EDC implementation services; as a result, Sponsors can expect a faster start for clinical trials, efficient cleaning of the clinical trial data, and faster lock of the clinical database with better clinical data quality.
Power and Simplicity at the Heart of the Clinical Trial
With Medidata's Rave intuitive web‐interface, multiple lingual capabilities, and combined EDC and paper capture features, FMD K&L can help Sponsors meet even the most rigorous trial requirements by recruiting sites and participants based on clinical needs ‐ not system requirements.
Data Capture and Data Cleaning is One Process - Not Two
Unlike traditional approaches, which separate the collection and management of clinical data, FMD K&L's Medidata RAVE EDC implementation services can make data capture and data cleaning a single, streamlined process. This reduces risk and improves efficiency throughout a study by eliminating the need for data reconciliation and the expense of managing separate systems. With all data captured and managed in the same system, reliable clinical data is available earlier in the research process instead of waiting until all data is locked. This allows researchers to have clean data available in real time throughout a study.
Industry Leading Ease of Use
Medidata RAVE EDC is designed to be intuitive to clinicians, trial monitors, and data managers with friendly and consistent point‐and‐click navigation and a familiar clinical data entry approach. Sponsors can recruit sites and investigators based on their clinical needs and skills, not computer knowledge and usage, to meet the requirements of today's clinical trials, including large‐scale registries and surveillance studies.
Medidata Rave's web-enabled interface works equally well on an Apple® computer or a Windows® PC, with the range of popular Internet browsers, including all versions of Internet Explorer®, Firefox®, and Safari®. Sponsors save the time and expense of provisioning and supporting specific hardware and software at sites, and only need to conduct simple assessments during site recruitment.
Multiple Trials, Multiple Languages - Single System
As organizations expand their participation in global trials, Medidata Rave lets users work in their language of choice, all within a single system. Full support for international (double‐byte) character sets and concurrent usage in multiple languages provides capabilities for multi‐national trials.
Paper and Paper / EDC Studies - Single System
FMD K&L's EDC implementation services use of Medidata Rave also offers the flexibility to conduct paper and paper / EDC clinical trials within a single system. With high‐speed double‐data entry, information captured in a paper‐based clinical trial can be managed in a single database with data collected electronically.
FMD K&L is an Oracle Health Sciences Business Partner.
FMD K&L is certified in Oracle InForm, an integrated electronic data capture and management platform that reduces clinical trial timelines, cost, and risk through advanced data capture and query management, real-time actionable visibility to data and standards-based, integrated workflows.
With Oracle InForm you can build a trial in as little as a few days and auto-deploy rapidly to a choice of 100,000 InForm-ready sites worldwide. We can assess and lock a site or an entire study in minutes and let you know if and when a patient took your drug. With Oracle InForm, we can easily collect, clean, and transform data from different sources for faster, more accurate analysis and submission.
- Comprehensive, proven open standards-based data capture cloud with automated and integrated workflows
- Complete core data capture capabilities: advanced query management, study design, coding, IRT, and more
- Full self-service deployment capabilities including mid-study changes, with no data migration required
Comprehensive Support for Industry Standards
Oracle Health Sciences InForm provides comprehensive support for industry standards such as CDISC to speed trial setup, increase efficiency and data quality, and help ensure compliance. As an active member and participant in groups including the CDISC Advisory Council, European CDISC Coordination Committee (E3C), and CDISC technical teams such as Define-XML and Protocol Representation, Oracle Health Sciences stays at the forefront of standards and their impact on clinical development. FMD K&L supports Oracle InForm for the following reasons:
- Oracle Health Sciences InForm offers pricing competitive with the market, with affordable study-based pricing as well as multi-study pricing discounts.
- With InForm, we can design trials in just a few days with comprehensive and fully integrated data capture, IRT, coding, and user and site management. We can auto-deploy trials rapidly to more than 100,000 InForm-ready sites worldwide, and assess, review, and lock a site or entire study in minutes.
- InForm provides real-time, actionable visibility to clinical data, comprehensive standard reporting and ad hoc reporting, and customizable review states. You quickly identify potential risks to trial timelines and data quality to take corrective action much earlier.
- Oracle Health Sciences InForm provides comprehensive, built-in edit checks, advanced query management and streamlined discrepancy management, targeted SDV down to the item level, and ready access to audit trail and reporting capabilities – helping to ensure high-quality data is delivered to biostats faster.
- Reduction of Risk
- InForm offers a proven track record across therapeutic areas and thousands of trials, from simple studies to highly complex protocols and global mega trials. In addition, the Oracle-owned and managed cloud follows the latest security best practices and governance applied across Oracle, products, and vendors – helping to keep your trial data safe.
FMD K&L is certified in Oracle Argus, a comprehensive pharmacovigilance platform which enables manufacturers to make faster and better safety decisions, optimize global compliance, and easily integrate risk management. Unlike solutions that require heavy customization, Oracle Argus provides deep and integrated safety functionality out of the box that scales to millions of cases and easily aligns with your safety and business processes.
The software enables a highly scalable end-to-end safety process providing automated global case processing, periodic reporting, E2B intake and submission, comprehensive reporting, detailed analytics, and Japanese safety operations from within a single system.
- Improve global compliance
- Increase efficiency of safety operations
- Enhance case quality
- Make faster, more informed safety decisions
- Scale easily to millions of cases
- Integrated, highly scalable end-to-end safety platform
- Single global database including Japan
- Common code base
- Regular release schedule
- Automated global case processing
- Periodic reporting
- E2B exchange
- Scientific querying
- Detailed analytics
- Out-of-the-box integration with Oracle Health Sciences InForm EDC Suite
- Make Faster, Better Safety and Risk Management Decisions
Oracle Argus provides comprehensive reporting, advanced analytics, and scientific querying for all levels of user ability to help you make fact-based safety decisions quickly.
- Argus self-service querying provides visibility to key safety data to set and manage risk-benefit ratios, letting you make timely, science based decisions on end-to-end safety and risk management.
- On-demand reporting provides detailed case information in minutes, letting you quickly and effectively prepare for and respond to regulatory information requests and audits.
- Real-time metrics measuring work in progress let you see current workload and resource utilization to make faster, better decisions on workload rebalancing before cases and reports become late.
- Trailing metrics measuring completed work provide visibility to volumes and trends over previous periods to quickly identify underperforming areas for additional training, staff augmentation, or process changes.
- Advanced scientific business intelligence offers efficient querying, drill-down analysis, and report generation with no impact on transactional performance so you can perform key analyses quickly and confidently.
- Argus utilizes built-in and configurable industry best practices that walk users through all required information for a case including internal deadlines, reducing the risk of missing data or cases entered late.
Choose Safety Software with Proven Performance, Reliability, and Scalability
Oracle Argus delivers a safety application, system, database, and hardware architecture and components built on leading Oracle technology.
- Argus features a highly robust and scalable architecture built on leading Oracle technology and optimized for maximum performance, scalability, and security so your data is reliable and secure whether you’re managing dozens or hundreds of thousands of cases per year.
- The Oracle Health Sciences well-established Software Development Life Cycle (SDLC) provides a rigorous and proven process that includes dedicated product strategists, domain experts, software engineers, audit and compliance, QA and more to ensure product performance, reliability, and security.
- Oracle Argus provides a stable, common code base among all customers, enabling fast, reliable and cost-effective updates and upgrades, as well as higher-quality support to increase compliance and productivity while reducing the risk of downtime and disruption.
FMD K&L and Oracle Health Sciences provide the vision, innovation, and resources to be your proven, long-term partners in safety technology supporting your business objectives.