ProPharma Group’s R&D technology services fill the void between life sciences and IT organizations by providing domain-specific technical consulting and validation services. From clinical system selection to implementation and validation, our expert staff ensures your project is a success.
What Are Clinical Technology Systems?
Clinical systems are used to collect, maintain, store and process patient information related to clinical trials. Having the right fit-for-purpose system in place is essential to get your product to market quickly and ensure compliance with regulatory requirements.
Core Clinical Systems
There is a range of clinical systems that can store your data and provide analytics to help you make decisions about the outcomes of your studies. These systems support the life cycle of your product and are comprised of an array of technologies including:
- Interactive Response Technology (IRT and RTSM)
- Clinical Data Management Systems (CDMS and EDC)
- Clinical Trial Management Systems (CTMS)
- Document Management Systems
- Regulatory Information Management Systems (RIMS)
- Pharmacovigilance (PV) and Safety Systems
- Electronic Trial Master File (eTMF)
- Electronic Clinical Outcome Assessment (eCOA, ePRO, eDiary)
- Data Warehouse and Analytics
- Data Visualization and Reporting
Typical Clinical Systems Projects
At ProPharma Group, we partner with you to select the software systems that will work best for your organization and goals, while ensuring compliance with FDA, EMA, MHRA, PMDA, and other regulatory requirements. We get your systems implemented efficiently, configure them to your specification and validate to ensure that your organization is audit-ready.
- Business Analysis and Process Optimization
- Project & Portfolio Management
- Systems Administration
- Systems Validation
- Custom Software Development & system integration
- Quality Assurance and SOP Development
- Change Management
- Workflow Process/Design
Why Outsource Your Clinical Systems Implementation?
Clinical trials involve an extensive amount of sensitive data moving through highly regulated systems. Maintaining GxP compliance during implementation, upgrade, enhancements, and configuration can be a challenge.
If you don’t have the expertise on staff to implement each new system, it is beneficial to utilize an experienced vendor to lead the implementation. Outsourcing the installation and validation of clinical systems provides the peace of mind that an expert who understands the ins and outs of each system will ensure that systems are configured in an optimal manner for your organization’s specific requirements.
ProPharma Group understands that you have an important job in getting your product to patients and technology should enable you to do that more quickly and more efficiently. Our team of experts will develop and deliver a tailored roadmap to help you hit your milestones.
For companies who want to sell their product globally, there are additional layers of regulatory requirements that must be met with your clinical systems. You need a provider who understands the regulations and can ensure your systems are compliant beyond the FDA.
Why Choose ProPharma Group’s Clinical Systems Team?
We Help with Technology Selection
There are many clinical systems out there and we know how hard it can be to determine which system is right for you. The most popular system may not be the right fit, and our teams are here to help you make sense of each system’s functionality so that you can make an informed decision.
Get a Less Fragmented Solution
While the system you choose often has its own in-house implementation team, ProPharma Group brings experience in implementing the entire suite of clinical systems. This way, you work with a single vendor for all your systems and our experts will ensure they’re working in harmony together.
Experience and Global Reach
ProPharma Group works exclusively with pharmaceutical, biotech, medical device, and diagnostic clients, and our consultants have deep expertise in navigating the ever-changing regulations protecting patient data. Currently operating in 45+ countries, our industry-specific technology consultants understand your unique challenges and can deliver on your projects.
Interested in learning more? Contact us today to discuss your clinical systems’ goals.