Functional Service Provision
In the rapidly evolving landscape of pharmaceutical, biotechnology, and medical device sectors, the ability to expedite regulatory submissions is crucial for success. Gurus stands out as a trusted partner and has a proven history of offering a comprehensive suite of services through our long-term Functional Service Provider (FSP) model. Our expertise spans across statistical programming, clinical data management and biostatistics, ensuring we are equipped to address the ever-changing needs of sponsors with professionalism and integrity.
BLUEPRINT FOR THE FSP MODEL
1 START
2 Setup
3
Ongoing Process
Ongoing Process
4
Continuous development
Continuous development
- Collaboration discussion
- Signing NDA and MSA
- Finalizing cooperation terms
- Resources utilization planning and allocation
- Sponser’s SOP and environment adaptation
- Training (specific macros or tools, if needed)
- Monthly/bi-monthly assessment meetings
- Make sure the service provided meets the clients’ needs
- Training provision for improvement areas (based on feedback)
- Based on the understanding of upcoming needs
- Fine tuning resources according to insights gathered from assessment meetings
- Exploring new areas for collaboration
Project-based Services
Gurus offers end-to-end partner solutions, for centralizing clinical data services. This helps avoid fragmented clinical data, makes communication easier, saves time, and keeps project updates readily available. The projects are handled by our team of experts, who have a proven history of successfully managing projects, ensuring integrity and accessibility for timely insights. Leveraging our strategic time zone, our team works efficiently with clients globally. A dedicated project manager ensures smooth project progression, while our robust governance structure guarantees quality and accountability at every stage. Additionally, our project-based services mean we take complete responsibility for the biometric components of your project, encompassing all aspects of data management, statistical analysis, and reporting to ensure the successful execution of your project's biometric requirements.
BLUEPRINT FOR PROJECT-BASED MODEL
1 START
2 Setup
3
Ongoing Process
Ongoing Process
4
Continuous development
Continuous development
- Collaboration/discussion
- Signing NDA and MSA
- Evaluation of project
- Finalizing cooperation terms
- Sponsor’s SOP and environment adaptation (if the project is conducted in sponsor’s environment)
- Resource planning and allocation according to the deadline
- Assigning contact person or Project manager from the Gurus side.
- Daily/Weekly/Monthly Meetings per sponsor request
- Monitoring SLA (Service Level Agreement)
- Thorough Governance
- Based on the understanding of upcoming projects
- Fine tuning resources according to insights gathered from the previous project
- Exploring new areas for collaboration
| Armenia | 9 am |
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| USA (EST) | 1 am |
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| India | 1030 am |
1130 am |
1230 pm |
130 pm |
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430 pm |
530 pm |
630 pm |
730 pm |
830 pm |
930 pm |
1030 pm |
1130 pm |
| Central Europe | 7 am |
8 am |
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12 pm |
1 pm |
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8 pm |