With clinical sites in the United States, Europe, & Africa, Pure Global can help meet your clinical needs. Our clinical team specializes in managing Pre-Market and Post-Market clinical trials, including study planning, study design, and clinical strategy development.
Clinical Trial Plan Support
Providing support in the preparation and evaluation of the clinical trial plan to ensure it meets all regulatory requirements and standards.
Research Budgets and Contracts
Preparation of research budgets, along with negotiation and execution of contracts with research centers, ensuring financial clarity and partnership integrity from the outset.
Preparation of documents
Assistance with preparing the necessary documentation to obtain permission for conducting both single-center and multi-center studies.
Procedure and Documentation Support
Supporting the preparation of essential procedures and study documentation, ensuring that all aspects of the trials are documented correctly and comprehensively.
Deliverable Report and Data Transfer
Secure the data integrity and completeness, validate the report on both analytical and clinical data, ensuring the electronic transfer's security.
Site Auditing and Monitoring
Conducting audits of research sites prior to the commencement of studies and ongoing monitoring during the study to ensure compliance with all study protocols and regulatory requirements.
We offer expertise in managing clinical trials for medical devices across the globe. Our team ensures regulatory compliance, strategic planning, and efficient data collection through our state-of-the-art laboratories and extensive trial site network.
Harmonizing ICH, GCP, ISO, and MDR Compliance with local regulations, our approach simplifies the regulatory process ensuring timely trial achievements.
From pilot to post market follow up and surveillance, our full range of services encompasses every aspect of clinical trial management, ensuring seamless progress and compliance at every step.
Our ISO and CLIA certified labs, coupled with a worldwide lab partners and clinical sites, empower your trials with the essential resources and expertise needed for success.
Our network of research and diagnostic laboratories with a diverse profile of activities rank among the leading trial sites in Europe and the United States.
The sites in our network meet the highest standards for clinical trial quality based on our numerous national and international certificates.
To discuss how we can assist with your entry into the target medical device market, please fill out our contact form.