Trial Execution

Medidata Solutions understands that for technology to provide real business value to your organization, it must be successfully deployed to enhance your unique way of performing clinical studies. To optimize and speed trial execution, Medidata provides a suite of services, including study build services, hosting, support services, training, knowledge transfer and consulting.

Medidata clients can select the right mix of services for their studies, from a comprehensive solution, to á la carte services and consulting that give you the control to manage your clinical research.

Study Build

Collaborative study builds
Our global implementation services organization can help you successfully implement your trial quickly and in close collaboration with the clinical study team, using best practices gathered over 10 years of implementing and building clinical studies. Professionals with deep industry experience are located throughout the world to assist you with your implementation regardless of project size or location.

Whether a customer chooses to implement Medidata Rave^® using a study by study license or an enterprise license, have Medidata deploy, host and support the study, or bring the implementation and support in-house, Medidata can provide the right level of service.

Medidata Rave Implementation Services
Objective: Successful study implementation of your clinical trial
Approach: Planning, consulting, managing and leveraging best practices in study implementation life cycle from study design to study close
Expertise: Project management, study design consulting, study configuration, quality control, data extraction, reporting, integrations and training

Training

Training tailored to fit your needs
Medidata Rave users train with diverse education modules with best practices tailored to fit the role, experience and interest of each user. Medidata's eLearning offering, built into Medidata Rave, provides rapid, targeted learning that gets investigators and other site personnel up and running in the system quickly.

Courses for Medidata Rave can be provided at Medidata training facilities, investigator meetings, or clients' facilities, as well as online through web-based training or eLearning. Project training occurs on the client’s EDC configuration, providing a real-life environment in which the best learning takes place. Train-the-trainer and instructor certifications are also available, enabling clients to incorporate Medidata Rave into their existing training processes.

eLearning Starts Studies Faster
eLearning is offered within the Medidata Rave application – an industry first – to enable users to dynamically learn the system before they get started. Once users successfully take the web-based course, they can immediately start entering data into your study.

Training made easy—from any web-enabled computer
Convenient—available anywhere, anytime
Flexible—role specific and customizable
Efficient—immediate study access after successful training

Hosting

Secure, state-of-the art data center
Whether you choose to conduct your clinical trials through study by study or enterprise licensing, we ensure the availability, redundancy and security of your clinical research data. Our secure state-of-the art data center has been engineered to exceed our customers' expectations for globally accessible, highly reliable, secure and scalable application performance. Medidata Hosting provides:

• The highest levels of security, reliability and disaster prevention and recovery
• Continuous on-site security
• On-site engineers around-the-clock
• High-speed firewall, intrusion detection and virus protection
• Redundant power sources from multiple power sources
• Backup cooling systems
• Multiple Internet access points and providers

Support

Global implementations...global support
Medidata Support Services provides multilingual help desk support to sponsors and users across the globe, up to 24 hours a day, 7 days a week for Medidata Rave. Our international help desk natively supports English, French, German, Italian, Japanese and Spanish. We can also support a number of other languages as required by our clients worldwide.

Our support technicians are experts in all Medidata products and have a comprehensive understanding of the full clinical trial process to facilitate communication with site users, no matter their level of technology expertise.

Knowledge Transfer

Services customized for you
Medidata clients can choose to have Medidata support and provide services for their clinical studies, or receive a knowledge transfer which gives them the control to build, manage and administer their studies themselves. Knowledge transfer enables clients to bring Medidata services in-house and gives them greater control of their clinical research.

The amount of support and service a client wants to bring in-house is flexible and a tailored knowledge transfer program is customized to each client based on their individual needs.

Consulting

Deep industry experience to enhance your clinical trials
Medidata Consulting’s mission is to advise our customers on ways to optimize their clinical development processes from protocol design through regulatory submission.

• Leverage best practices in the use of clinical technologies
• Streamline and enhance trial processes
• Increase their competitiveness in the market

Medidata offers three consulting services to advise customers on ways to optimize their trial processes and use of technology:

Technology

• Optimize use of Medidata products
• Enhance technology integrations & architecture

Process

• Institute robust operational processes and metrics based on in-depth analysis
• Develop efficiencies in operational processes

Knowledge

• Enable the use of industry standards, such as CDISC and CDASH
• Transfer knowledge capital to our customers