Medidata Services Partners

The Medidata Partner Program (“MPP”) recognizes leading contract research organizations (CROs), consultancies and systems integrators to share Medidata’s mission to streamline and enhance the clinical research process. The program acknowledges organizations that offer solutions and/or services that are complementary to the Medidata product portfolio and further extend value for our customers.

Medidata Services Partners (“Partner”) are the leading CROs and service providers that have been enabled to provide services that leverage Medidata’s innovative solutions to optimize sponsors’ clinical trials. Medidata’s SaaS clinical development solutions are increasingly the choice of CROs worldwide who require clinical systems with the flexibility, configurability and scalability to meet sponsors’ unique and rigorous clinical research needs. Sponsors have the choice of a broad range of accredited CROs, systems integrators and other service providers.

1. Medidata Partner Accreditations

Accreditation is a training and education program intended to provide Partners with the tools necessary to provide implementation, configuration, support and use of the Medidata products and applications for Authorized Users. Medidata Partners select from the available product Accreditation(s) based on their capabilities and expertise.  The parties will enter into a Sales Order outlining the scope of the relevant Accreditation process along with any pre-requisites or qualifiers to the Accreditation. Upon completing Accreditation requirements, a Medidata Partner will be authorized to market the Applications and Medidata services for the solution set. (Note: Partners will not be authorized to use any Medidata applications to process live study data within a “sandbox” or non-production environment.)

A list of available Medidata Application Services Accreditations is listed below:

• Rave EDC –  Partners are trained on the functionality of the electronic data capture (EDC) and clinical data management (CDM) system, process optimization exercises and scope of Medidata Rave services. This Accreditation teaches the staff to perform end user training, user and site administration, study build, reporting, outputs and amendment manager.

• RTSM – Partners are trained on the functionality of the RTSM Application, process optimization, best practices using RTSM, and scope of RTSM services. This Accreditation teaches Partners to conduct randomization and clinical trial supply management services (RTSM). RTSM Accreditation is dependent on the successful completion of the Rave EDC Accreditation.

• Coder – Partners are trained on the functionality of the Coder application, process optimization, and scope of Coder services. This Accreditation teaches Partners to integrate the medical coding solution with EDC studies and administer Coder segments. Coder Accreditation is dependent on the successful completion of the Rave EDC accreditation.

• Safety Gateway – Partners are trained on the functionality of the Safety Gateway application, process optimization, and scope of Safety Gateway services. This Accreditation teaches Partners to utilize the configurable EDC-to-safety-system interface to automate advanced serious adverse event (SAE) collection and E2B transmissions. Safety Gateway Accreditation is dependent on the successful completion of the Rave EDC Accreditation.

• TSDV – Partners are trained on the functionality of the targeted source document verification (TSDV) application, process optimization, and scope of TSDV services. This Accreditation teaches Partners to implement TSDV in line with regulatory compliance and data quality strategies. TSDV Accreditation is dependent on the successful completion of the Rave EDC Accreditation.

• Medidata Medical Imaging – Partners are trained on the functionality of the Medidata Medical Imaging application, best practices and integration requirements as applicable, as well as the scope of Medidata Medical Imaging services. This Accreditation teaches the Partners to perform configuration of studies, end user training, user & site administration for Medidata Medical Imaging studies.

• eCOA – Partners are trained on the functionality of the eCOA application, best practices, process optimization and the scope of eCOA services. This Accreditation teaches Partners to process patient data that has been entered by the patient themselves, or by a Clinician. Patients enter their patient data through a provisioned device or their own device after downloading the appropriate app.  Clinicians enter patient data through a provisioned device (Android or iOS). eCOA Accreditation is dependent on the successful completion of the Rave EDC Accreditation.

• eConsent – Partners are trained on the functionality of the eConsent application, best practices, and scope of eConsent services. This Accreditation teaches Partners to digitally present the various consent and authorization forms required as evidence of protection of human subjects in clinical investigations. Once accredited, the Partners can perform the configuration of studies, support end user training, user and site administration for eConsent studies. eConsent Accreditation is dependent on the successful completion of the Rave EDC Accreditation if Partners wish to integrate with Rave EDC.

• Medidata Remote Source Review –  Partners are trained on the functionality of the Medidata Remote Source Review application, best practices and scope of Medidata Remote Source Review services. The Accreditation will focus on support source document collection, uploaded document quality control and site query(ies). This Accreditation teaches the Partners to perform configuration of studies, end user training, and user and  site administration for Remote Source Review studies.

• Medidata Adjudicate –  Partners are trained on the functionality of the Adjudicate application, best practices and scope of Adjudicate services.  The Accreditation will focus on technical tools for data that require collection of documentation of adverse events that require adjudication, uploaded document quality control and dossier creation; query(ies); and design of adjudications. This Accreditation teaches the Partners to perform configuration of studies, end user training, and user and site administration for Adjudicate studies.

• Site Cloud: End Of Study Media – Partners are trained on the functionality and administration of Site Cloud: End of Study content distribution. This includes study and site access provisioning, site content download, and electronic signature acknowledgement. This Accreditation teaches the Partner to administer the electronic distribution and management of study files to sites, including the centralized collection of acknowledgement of receipt documents following delivery.

Medidata maintains variable Accreditation Program Tiers to fit a Partners’ user and study configuration needs.  The Program Tiers will be reviewed prior to executing an Accreditation Sales Order to fit the purpose of the Partner.

2. Requirements for Accreditation.

Partners need to complete the following general path to earn their Accreditation:

• Training. Partners learn about the product’s features and functionality through eLearning and/or instructor-led training. If applicable, Partner staff configure a simulated study in their sandbox environment. Partner study builders will also seek certification to reach the minimum requirements.

• Process Optimization. Partners assess their current process and create new or update existing Partner process to incorporate the application /product, through a series of exercises or workshops. Medidata will demonstrate implementation strategies and best practices with suggestions for process optimization. Partners then customize templates and update implementation processes and Standard Operating Procedures (SOP’s) to be ready for configuration of their first production study.

• Build Training. Partners use the knowledge gained during process facilitation and training phase to configure a study. Partners can also leverage the Medidata support included in the Accreditation process as specified in the Sales Order. Before Accreditation is achieved by the Partner, any additional production studies implemented will require Medidata support at an additional cost.

NOTE:  For eCOA and eConsent Accreditation – it is expected that more than one (1) study may be attached to an Accreditation process. Support will be managed by a ‘crawl, walk, run’ methodology with Partners ‘watching, doing, owning’ a study configuration and operation respectively, with increasing responsibility.

NOTE: For Safety Gateway Accreditation, it is expected that more than one (1) study may be attached to an Accreditation process. Support will be managed by a ‘watch one, do one’ methodology with Partners shadowing then owning.

• Operational Review. The final step to achieve Accreditation includes a review of the Partner’s operational procedures to ensure the proper cross-functional implementation processes (SOPs/WIs) are in place to support the solution deployment. Partners also describe their sales deployment strategy. Upon successful completion of this milestone, Medidata Services Partners can independently deliver solutions and services to their customers. Medidata reserves the right to perform operational reviews in accordance with the Agreement at any point during the Partnership. These services are dependent on the Accreditation track selected and verified during operational review.

3. Minimum Staff Commitments and Timelines.

a)    Partner to provide a dedicated Accreditation team to commit to participate in workshops, training and weekly meetings for the required months until completion of the product Accreditation.

The time required for each product is set out in a Sales Order for the applicable product and covers instructor-led courses, eLearning training and workshops.

b)   Partner will be charged additional fees in the event a Partner resource leaves or moves from the project during the Accreditation engagement period.

c)    Partner shall schedule training for its contracted Accreditation within thirty (30) days following execution of the applicable Sales Order. Partner shall complete the Accreditation program within twelve (12) months from execution of the Sales Order unless otherwise defined in the Sales Order.

d)    Failure to complete the Accreditation program within the defined time frame may result in the Partner having to complete re-training at additional cost.

Partners are expected to maintain the following numbers of trained and certified individuals:

NOTES:

“Trained Individuals” is the requirement for each listed Accreditations to have a designated number of individuals trained.  A “trained individual” must be either trained by Medidata directly or trained by an approved trainer under a Medidata Train The Trainer program.

Certified Individual is the requirement defined to have the designated number of individuals complete and pass an assessment(s) in order to work with the Application.

The Minimum Requirements/Staff Commitments set forth above for each product Accreditation represents the total number of individuals to be trained/certified (inclusive of applicable cross-functional teams within your organization).

Details of functions and numbers are defined for each product and will be set out in the Sales Order.

4. Partner Operational Support Cycle

a) Platform Optimization Review

• A review of the Partner’s actual use of the software and/or platform is conducted to ensure the Partner is using the software and/or platform to its full capability. This review includes, but is not limited to:
• URL analysis (age of the URL, version, number of URLs in use)
• Product use (efficiency and functionality)
• The number of submitted tickets to Help Desk
• Medidata and Partner shall meet annually (at a minimum) to review Partner’s usage level of the software and/or platform and discuss, if applicable, how the Partner can use the software and/or platform to its full capability.

b) Accreditation Assessment Review

• This review is conducted to ensure that all Accreditation requirements are current. This review includes, but is not limited to:
• Minimum number of trained and certified staff are present
• Certifications and trainings are up to date by reviewing the Partner’s Medidata Global Education Training Records, which includes eLearning and Instructor-Led Training Courses
• Partner’s processes and procedures (pursuant to the applicable Sales Order and Partner’s internal procedure) to support the Subscription Services used by Partner
• Medidata and Partner shall meet every 2 years (at a minimum) to review the Partner’s Accreditation status.

5. Training Session & Cancellation Policy.

For training delivered by Medidata Global Education (formerly Medidata Academy) please review Medidata Global Education Services Cancellation Policy. Courses delivered by Medidata Global Education (formerly Medidata Global Education) are dependent on the Accreditation and details can be provided upon request.

For workshops and other sessions, cancellation will be managed on a per instance basis or as defined in the Sales Order.

6. Subject to Change.

The Medidata accreditation process is subject to change in Medidata’s sole discretion upon written notice to Partner of material changes.

Rev. 9/23