Medidata Services Partners – Accreditation Policy Document

Medidata Services Partners

Accreditation Policy Document

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 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 Patient Cloud Accreditation – Partners are trained on the functionality of the Medidata Patient Cloud Application, process optimization, and scope of Medidata Patient Cloud services. This accreditation enables Partners to capture patient-centric data and establish direct patient communications via patients’ own iOS devices. Medidata Patient Cloud 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 to perform configuration, end-user training and user administration for Rave Design Optimizer

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 the execution of this Agreement. 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.

Accreditation 

Minimum # of Trained Staff

Minimum # Certified Staff (pass exam)

Medidata Rave Three (3) Individuals Three (3) Individuals
Medidata Rave RTSM Four (4) Individuals N/A
Medidata Rave Coder Four (4) Individuals N/A
Medidata Rave Patient Cloud Four (4) Individuals N/A
Medidata Rave Safety Gateway Four (4) Individuals N/A
Medidata Rave Targeted SDV Four (4) Individuals N/A
Medidata Design Optimizer Two (2) Individuals N/A
Medidata Grants Manager Two (2) Individuals Two (2) Individuals
Medidata Rave Imaging Four (4) Individuals N/A
Medidata Rave Site Payments Two (4) Individuals Three (4) Individuals

* 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 Application.

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 that reveal Medidata’s implementation strategies and/or suggestions for process optimization. Partners then customize templates and update implementation processes to be ready for configuration of their first production study.
  • Build Enablement. Partners use the knowledge the gained during Process enablement and training phase to a 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.
  • 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 the Agreement at any point during the partnership.