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 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 Service 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, Licenses 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 Balance® 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 electronic data capture (EDC) studies and administer Medidata Coder segments. Medidata Coder accreditation is dependent on the completion of the Medidata Rave accreditation.
- Medidata CTMS™ Accreditation – Partners are trained on the functionality of the Clinical Trial Management System (CTMS) Applications, process optimization and scope of Medidata CTMS services. This accreditation enables Partners to use CTMS modules for study planning, start-up and conduct, along with financial management and trial monitoring.
- Medidata Designer® Accreditation – Partners are trained on the functionality of the Medidata Designer Application, best practices and integration requirements as applicable, as well as the scope of Medidata Designer services. This accreditation enables Partners to conduct optimized study design, streamline study setup and execution, and reuse design concept to generate eProtocols and other clinical documents.
- Medidata Grants Manager® 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 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® Accreditation – Partners are trained on the functionality of the (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 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 Medidata Rave Accreditation.
- Medidata TSDV Accreditation – Partners are trained on the functionality of the Medidata Targeted Source Document Verification (TSDV) Application, process optimization and scope of Medidata TSDV services. This accreditation enables Partners to implement partial SDV in line with regulatory compliance and data quality strategies. TSDV Accreditation is dependent on the completion of the Medidata Rave Accreditation.
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/Statement of Work (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 and training shall be completed within one hundred and eighty (180) days, unless stated differently in the Sales Order/Statement of Work.
c) Partner shall maintain a training plan that defines Partner’s plans to train personnel as needed.
Minimum # of Trained Staff
Minimum # of Certified Staff (pass exam)
|Medidata Balance||Four (4) individuals||N/A|
|Medidata Coder||Four (4) individuals||N/A|
|Medidata CTMS||Two (2) individuals||There is currently no requirement for Medidata Certified Monitor|
|Medidata Designer||Two (2) individuals||N/A|
|Medidata Grants Manager||Two (2) individuals||Two (2) Individuals certified – Medidata Grants Manager Certified User|
|Medidata Patient Cloud||Four (4) individuals||N/A|
|Medidata Rave||Three (3) Individuals||Three (3) Individuals certified –Medidata Rave Certified Study Builder|
|Rave Safety Gateway||Four (4) individuals||N/A|
|Rave Targeted SDV||Four (4) individuals||N/A|
*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
a) Locations. All training will be provided at Medidata locations as determined by Medidata or such other locations as agreed by Medidata and Partner.
b) Training Sessions Not Exclusive. Medidata may train personnel of its customers and other Partners at the same and in the same classes as it is training Partner’s trainees. A maximum of ten (10) people per class is allowed for training courses. Public classes may have others in attendance.
c) Training Cancellations. After training sessions have been scheduled, Partner will be responsible for payment of cancellation and rescheduling fees equal to a percentage of applicable fees as follows:
Cancellation Notice Received by Medidata
|Twenty (20) or more business days prior to the scheduled training session.||No Fee|
|Between twenty (20) and ten (10) business days prior to the scheduled training session.||25%|
|Between ten (10) business days and five (5) business days prior to the scheduled training session.||50%|
|Five (5) business days or less prior to the scheduled training session.||100%|
Medidata reserves the right to modify the above-described cancellation policy upon written notice to Partner, however such modifications shall only apply to training sessions to be delivered by Medidata after the effective date of such modifications.
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 are enabled to build a production study while Medidata mentorship is required. Some degree of mentorship (at no additional cost to the Partner) is required until the Partner is accredited.
- 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 at any point during the partnership.