Study Design

Implementation

Facilitate protocol design and speed study start-up
Medidata can facilitate protocol design by supporting Medidata Designer^® with in-depth implementation services, training and support services. By implementing Medidata Designer, a sponsor’s protocol authoring process can be more efficient and can conform with industry standards.

Medidata Designer Implementation Services
Objective: Facilitate protocol authoring and study start-up
Approach: Leveraging best practices in structured and standardized protocol authoring and facilitating more efficient collaboration and use of protocol knowledge throughout the clinical research process
Expertise: Project management, study design consulting, CDISC and HL7 standards expertise

Training

Training tailored to fit your needs
Medidata University offers sponsors the training needed to design protocols with confidence using Medidata Designer. Medidata users train with instructor-led or eLearning customized modules and related materials, incorporating customer-specific content and examples to deliver a hands-on experience in the context of the user-specific roles, responsibilities and level of experience. Instructor-led courses for Designer are provided at clients' facilities. Train-the-trainer courses are also available, enabling clients to bring Designer training in-house.

Support

Global implementations... global support
Medidata's Support Services provides phone support for study design services from 8am to 5:30pm Eastern Time and e-mail support from 8am to 9pm Eastern Time. In addition to English, questions and comments can be addressed in Danish, French, German, Italian, Japanese, Mandarin and Spanish.

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.

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 Consulting provides in-depth services for study design:

• Efficiently and effectively integrate eClinical technologies and technology architecture
• Enable the use of industry standards, such as CDISC and CDASH standards