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- Conducted in several countries with different cultural, political and regulatory environments.
- Studying the effects of new therapies on humans and attentively monitoring and reporting the outcomes
- Managed within economic and budgetary limitations that deal with several financial and operational risks
- Communicated using many languages, data systems and varying levels of supporting infrastructure
With this complexity: Things will never go according to plan.
Successful management of clinical trials requires innovative solutions with flexibility and the ability to change and adapt. We embrace ANY model that adds value to your project.
Supporting Models:
Full Service CRO Model:
MPR has the resources and capabilities to undertake most of clinical trial projects as a full service CRO and internationally. The full service model is ideal when the Sponsors have limited resources and deployment of additional staff is costly or impractical.
The FSP Model:
The Functional Service Provider Model, FSP, is ideal when Sponsors only need assistance in certain functions or geographic locations or need additional staff to support current in-house departments. The FSP will therefore compliment and integrate our staffing with the Sponsors’ staff. We will assist our clients defining and optimizing the best support model.
The Hybrid Model:
At MPR, we realize the existence of structural and support gaps between Sponsors and CRO on one side and Investigators and Sites on the other. We therefore, embrace the Hybrid Model that emphasizes CRO/SMO support systems in several international locations, including North America and Central/Eastern Europe. The Hybrid model enables MPR or any of its affiliates to completely compliment Sponsors’ resources managing studies, whether they have another CRO or do not work with CROs.
Start with a 3P Engineering DSS Study:
We realize how important it is to be right! Any small mistake in planning your project may have significant consequences in the future success of the study. We therefore, encourage you to launch with us a 3P Engineering DSS study: this study, whether you are half way planning or just started or almost done planning your project, is a very helpful tool to guide you supporting your project.
3P Engineering is a study that is conducted for clients who want to optimize their outsourcing strategy for their clinical trials. After defining the major elements of a research protocol including the number of patients needed, sponsors are faced with several questions:
- How many sites needed?
- What countries and which countries should be selected?
- What services to outsource and to whom:
- Full Service CRO?
- Functional Services Outsourcing?
- Hybrid?
- EDC vs. CRF
- How much will it cost?
- How long? Regulatory approval? Recruitment? Completion? Reporting?
- What are the operational and financial risks? and how to alleviate them?
The answers to all these questions are very unique for each Sponsor and for each clinical trial.
A 3P-Engineering study conducted by MPR intends to build an intelligent model to answer and optimize the plan
- P: Project
- P: Process
- P: Price
Optimizing where and what to outsource are defined by the first P: Defining the Project. This section defines the countries where the study will be conducted including timeline
Optimizing how to outsource, Quality System, Pharmacovigilance plan, what tools to use, EDC vs. CRF, data management, all other details will be defined in the second P: Process
Optimizing the budget and expenses in the life cycle of the project and studying risks, including currency risks, will be defined in the third P: Price
MPR 3P-Engineering study is proactive and enables decision makers to conduct iterative scenarios. The scale and scope of the study are also flexible and according to the Sponsor needs.