Speed, Compliance, and Quality at Every Stage of Your Research
We take your study from initial concept to final report, or step in exactly where support is needed.
Choose an end-to-end pathway or targeted expertise by exploring our solutions by project stage or strategic area.
Let’s find the right approach for your project.
By Project Phase
Study Preparation
Solid foundations from day one
We establish the regulatory and organizational foundations your study needs to get started and ensure compliance from the outset.
Study Start-Up
From approvals to patient enrollment
We manage approvals, contracts, and site activation to begin patient enrollment on schedule.
Study Development
Quality and execution under control
We manage clinical monitoring and data management throughout the study to keep it consistently on track.
Study Conclusion
Analysis and Reporting
We bring your clinical study to completion and deliver the analysis and reporting required for regulatory assessment.
By Strategic Area
Quality Services
Quality systems throughout every stage of your project
We design and maintain quality management systems that keep your processes compliant and reliable throughout the entire project.
Regulatory Services – We4 Regulatory
Approvals, registrations, and compliance under control
We manage the requirements that keep your clinical study and medical device aligned with the applicable regulations.
Clinical Services
From site selection to patient follow-up
We conduct your studies with hands-on oversight and transparent communication.
Post-Market Services
After launch, data becomes evidence
We turn post-market data into meaningful insights while maintaining compliance with applicable regulations and standards.
One partner or several separate vendors? CRO and regulatory services compared
| 1 partner (We4CR) | Multiple vendors | |
|---|---|---|
| Points of contact | 1 partner (We4CR)A single point of contact who knows the whole project. | Multiple vendorsSeveral contacts to coordinate. |
| Handovers | 1 partner (We4CR)Clinical and regulatory teams in the same group, with less information lost along the way. | Multiple vendorsEvery handover between vendors risks losing information or having to re-explain it. |
| Clinical evaluation | 1 partner (We4CR)Study data reaches the report from the people who collected it. | Multiple vendorsData has to be re-explained to whoever writes the report. |
| Clinical investigation (ISO 14155, MDR) | 1 partner (We4CR)Study and MDR requirements followed together, from the start. | Multiple vendorsTwo teams that talk to each other through you, who must always keep the whole project context clear. |
| Notified Body relations | 1 partner (We4CR)Answers come from someone who knows both the study and the technical documentation. | Multiple vendorsQuestions bounce between several consultants, who may not have the full project context and need to be realigned each time. |
| Quality and audits | 1 partner (We4CR)A single quality system to present. | Multiple vendorsSeveral quality systems to align with each other. |
| Post-market follow-up (PMCF) | 1 partner (We4CR)Clinical data collection after the investigation starts again from the study data, with people who already know it well. | Multiple vendorsA new vendor starts again from the files handed over, and it’s up to you to rebuild the project in an orderly way. |
| Contract | 1 partner (We4CR)A single contract and a clearer scope. | Multiple vendorsSeveral contracts, more invoices to manage. |