Medidata Services Partners – Accreditation Policy Document

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 other 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

Medidata Partners select from the available product accreditations based on their capabilities and  expertise. 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 live within a “sandbox” or non-production environment.)  A list of available accreditations are listed below. 

• Medidata Rave Accreditation – 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 enables the staff to  perform end user training, user and site administration, study build, reporting, outputs and  migration services.  
• Medidata Rave RTSM Accreditation –Partners are trained on the functionality of the  Medidata Balance Applications, process optimization, and scope of Medidata Balance  services. This accreditation enables Partners to conduct randomization and drug trial supply  management services. Medidata Balance accreditation is dependent on the completion of  the Medidata Rave accreditation. 
• Medidata Coder Accreditation –Partners are trained on the functionality of the Medidata  Coder Application, process optimization, and scope of Medidata Coder services. This  accreditation enables Partners to integrate the medical coding solution with EDC studies and  administer Medidata Coder segments. Medidata Coder accreditation is dependent on the  completion of the Medidata Rave accreditation. 
• Medidata Rave Safety Gateway Accreditation – Partners are trained on the functionality of  the Medidata Rave Safety Gateway Application, process optimization, and scope of  Medidata Rave Safety Gateway services. This accreditation enables 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  completion of the Rave Accreditation. 
• Medidata Rave Targeted SDV Accreditation – Partners are trained on the functionality of  the Medidata Rave Targeted Source Document Verification (SDV) Application, process  optimization, and scope of Medidata Rave Targeted SDV services. This accreditation enables  Partners to implement partial SDV in line with regulatory compliance and data quality  strategies. Targeted SDV Accreditation is dependent on the completion of the Rave  Accreditation. 
• Medidata Rave Imaging – Partners are trained on the functionality of the Medidata Rave  Imaging Application, best practices and integration requirements as applicable, as well as  the scope of Medidata Rave Imaging services. This accreditation enables the Partners to  perform configuration of studies, end user training, user and site administration for Imaging  studies.  
• Medidata Rave Site Grants Accreditation – Partners are trained on the functionality of the  Medidata Grants Manager Applications, best practices and integration requirements as  applicable, as well as the scope of Medidata Grants Manager services. This accreditation  enables Partners to provide services around trial budgeting and planning to accurately  predict study costs and site negotiation features, if applicable.  
• Medidata Rave Site Payments – Partners are trained on the functionality of the Medidata  Rave Site Payments, best practices and integration requirements as applicable, as well as the  scope of Medidata Payment services including disbursements. This accreditation enables  Partners to perform configuration, end user training user administration for Site Payment  studies.  
• Medidata Rave Design Optimizer – Partners are trained on the functionality of the Medidata  Rave Design Optimizer, best practices and integration requirements as applicable, as well as  the scope of Medidata Payment services including disbursements. After completion of the  Accreditation program Partners are able perform configuration, end user training and user  administration for Rave Design Optimizer 
• Medidata Rave eCOA Accreditation – Partners are trained on the functionality of the  Medidata eCOA Application, best practices, process optimization and the scope of eCOA  services. This accreditation enables Partners to patient data via patients own device or  through a provisioned device (Android or iOS). Medidata Rave eCOA accreditation is  dependent on the completion of the Medidata Rave accreditation.  
• Medidata Rave eConsent Accreditation – Partners are trained on the functionality of the  Medidata eConsent Application, best practices and scope of eConsent services. This  accreditation enables Partners to present digitally, the various consent and authorization  forms that are required as evidence of protection of human subjects in clinical investigations.  Once accredited the Partners are able to perform the configuration of studies, support end  user training, user and site administration for eConsent studies. Medidata Rave eConsent  accreditation is dependent on the completion of the Medidata Rave accreditation and the  completion of at least one (1) or eConsent study with Medidata as builder.
• Medidata Remote Source Review Accreditation – 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 enables the Partners to perform configuration of studies, end user training and user and site administration for Remote Source Review studies.

2. Minimum Requirements/ Staff Commitments.

a) Partner shall commit its personnel to participate in the training curriculum, including completion  of instructor-led and eLearning courses and attending process optimization workshops, as set forth  in the applicable Sales Order (the “Training Curriculum and Budget”) for the applicable accreditation. 

b) Partner shall schedule training for its contracted accreditation within thirty (30) days following execution of this Agreement. Partner shall complete the accreditation program within twelve (12)  months from execution of this Agreement with the exception of Rave eCOA where the program  duration is documented in the Sales Order (SO). Failure to complete the Accreditation program within the defined time frame, may result in Partner having to complete re-training at cost.  

c) Partner shall maintain a training plan that defines Partner’s plans to train personnel as needed.

* Certified Staff Member is the requirement for the course defined to have the designated number of  individuals complete and pass an exam in order to work with the Application. 

** Trained Staff Members for Rave eCOA Accreditation should be a minimum of:

• Two (2) Builders/Project Designers/Data Managers/Programmers and,
• Two (2) Project/Operations Managers

3.  Subject to Change.

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

4. Training Session & Cancellation Policy.

For training delivered by the Medidata Academy please review “Medidata Academy Training Delivery Cancellation Policy”. Courses delivered by the Medidata Academy are dependent on the Accreditation and details can be provided upon request.  

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

5.  Requirements for Accreditation.

Partners need to complete this approximate enablement path to complete 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 Enablement. Partners complete process enablement through a series of exercises or  an enablement workshop/webex training that reveal Medidata’s implementation strategies and/or 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 Enablement. Partners use the knowledge gained during process enablement and training  phase to configure a study. Partners can also leverage the Medidata mentorship included in  the Accreditation program for one (1) study. Additional production studies implemented  before Accreditation is achieved by Partner will require Medidata support at an additional cost.

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

• 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. 

Note: For Rave eCOA and Rave eConsent Accreditation capabilities achieved are dependent on  the Accreditation track selected and verified at Operational Review. Capabilities successfully  achieved by the Partner will be certified.