Partnerships and Strategic Alliances

FMD K&L is a Medidata Services Partner

Through this world‐class partnership, we provide services leveraging 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, so that sponsors can expect a faster start for clinical trials, efficient cleaning of 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 comprise one process – not two

Unlike traditional approaches separating the collection and management of clinical data, FMD K&L’s Medidata Rave EDC implementation services consolidate data capture and data cleaning into 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 are available earlier in the research process instead of waiting until all data are 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 for 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 Apple or 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

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

Oracle InForm

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.

Key features

  • 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 such as 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:

Key benefits

  • Affordability
    • Pricing competitive with the market, with affordable study-based pricing as well as multi-study pricing discounts
  • Efficiency
    • Trial design in just a few days with comprehensive and fully integrated data capture, IRT, coding, and user and site management; auto-deploy trials rapidly to >100,000 InForm-ready sites worldwide; assess, review, lock a site or entire study in minutes
  • Oversight
    • Real-time, actionable visibility to clinical data, comprehensive standard and ad hoc reporting, customizable review states; quickly identify potential risks to trial timelines and data quality to take corrective action much earlier
  • Quality
    • 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
  • Risk reduction
    • Proven track record across therapeutic areas and thousands of trials, from simple studies to highly complex protocols and global mega trials; Oracle-owned and -managed cloud follows latest security best practices and governance applied across Oracle, products, and vendors, helping to keep your trial data safe

Oracle Argus

FMD K&L is certified in Oracle Argus, a comprehensive pharmacovigilance platform enabling manufacturers to make faster and better safety decisions, optimize global compliance, and easily integrate risk management. Unlike solutions requiring 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.

Key benefits

  • 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.

  • 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
  • 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
  • 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 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.

FMD K&L is an OpenClinica Partner for price-sensitive Sponsors

FMD K&L chose the OpenClinica EDC platform to create flexible software built on open standards and architectures and provide an alternative to some of the higher priced EDC platforms on the market today. Our partnership with OpenClinica, using their Enterprise Edition, empowers us to rapidly deploy intuitive and highly capable data capture solutions in support of our trial Sponsors’ high-quality clinical data needs.

OpenClinica now is being used in more than 3,000 studies and has proven success within our own client base. The software allows us to rapidly configure protocols, eCRFs using intuitive tools requiring no programming. OpenClinica gives sites an easy, intuitive way to provide accurate study data, auto-notify site users with actions required and auto-manage study calendars. It also applies electronic signatures when needed.

OpenClinica equips FMD K&L with powerful tools for centrally reviewing data, resolving queries, and flagging discrepancies. It uses sophisticated edit checks to ensure accurate data capture and maintain accurate data to close studies faster, including aggregate data from disparate sources. OpenClinica provides data to stakeholders in useful formats and exceptional tools for study closeout.

We believe OpenClinica gives monitors a mobile-friendly dashboard to assist them in the field, showing what they need to do and when they need to do it, including reviewing site activities and verifying data against source. Finally, OpenClinica allows patients to provide data anytime, anywhere from their own device, as well as provide timely notifications when data are required.

We like the performance of OpenClinica tools when applicable and can determine upon review of your protocol or synopsis whether or not OpenClinica is right for you. OpenClinica brings another low-cost standard to your studies with high performance in mind.

FMD K&L is an SAS Institute Partner

Since the very beginning, when FMD K&L was founded, we have been using SAS software, because along with its easy-to-learn, flexible programming language, our programming staff can deploy “ready-to-use” programs for data manipulation, information storage and retrieval, descriptive statistics and reporting, a centralized metadata repository and a macro facility reducing programming time and maintenance headaches, all within a multithreaded, scalable and high-performance environment. This translates to less money and time for your project.

FMD K&L prefers an open, cross-platform architecture and environment that integrates into any computing environment infrastructure, enabling us to unify all computing efforts and get a single view of your submission data. From small data issues to complex data problems, our programmers can read, format, analyze and report on data quickly, regardless of format.

SAS is an intuitive and easy-to-learn programming language with built-in procedures that significantly reduce the amount of code needed to deliver information. SAS procedures encapsulate and deliver functionality with a few simple commands, increasing programmers’ productivity. This is one of the reasons our staff is so efficient and fast in delivering your datasets.

If and when the FDA asks to see the source code for any program, you can be confident that there are no hidden proprietary codes or mechanisms, only SAS code that can be sent directly to FDA or any other regulatory agency. This helps to build confidence with the medical reviewers and eliminates many questions about traceability and code origin.

SAS – another industry standard you can count on from FMD K&L.

FMD K&L is a CDISC Partner

The Clinical Data Interchange Standards Consortium (CDISC) is a 501(c)3 global, non-profit charitable organization that develops data standards to streamline clinical research and enable connections to healthcare, empowering the valuable information offered by patients participating in research studies around the world. Involved with CDISC standards since 2002, FMD K&L is a CDISC Registered Solutions Provider and Gold Member. For details on how our partnership with CDISC bolsters our CDISC implementation and eSubmission services, click here