Paragon offers a comprehensive array of clinical research services to the pharmaceutical, biotech and medical device industries. For more detailed information about these services, select from the following links:
Paragon hires the most talented and experienced project managers in the industry. We enhance their skills with internal, customer-centric training that ensures clients truly unsurpassed service.
Our project managers act as the liaison with the sponsor to ensure that all deliverables are met. They are committed to maintaining flexibility and cost management. And as leaders of a multidisciplinary operational team, they are empowered to oversee every aspect of clinical trial management and handle changes and new objectives as they arise.
Our project management teams are supported by innovative clinical tools and systems, including our Clinical Trials Management System (CTMS), which provides a variety of reports with up-to-date study information. These customized reports enable project managers to anticipate the next step in the study process and proactively handle potential issues.
Another recent Paragon innovation is the Project Excelerator™. This global project management tool effectively tracks, analyzes, recalculates and updates projections of investigative site activity and subject enrollment. The added ability to run project simulations both prospectively and retrospectively allows for initial and ongoing country and site optimization, and provides invaluable lessons for ongoing improvement.
Paragon understands that proper planning is key to conducting a successful trial. Through our experienced clinical team, extensive Clinical Research database and customized comprehensive feasibility questionnaires, Paragon can provide our customers with the necessary enrollment strategies, timelines and site selections to efficiently initiate a trial.
At Paragon, we understand the right clinical investigators is crucial to the success of your trial. Our Clinical Trial Management System (CTMS) investigator database helps us recruit and select the right investigators for your study, and initiate your trial quickly and efficiently
We maintain a centralized documents system for processing and storage that is managed at our corporate headquarters. This frees our monitors in the field from the administrative task of overseeing this process at the site level and makes site recruitment, selection, and the independent review board (IRB) approval process more efficient.
We ensure efficiency at study start-up by providing a comprehensive binder to the site, detailing the required documentation for your study. We prefer to select clinical investigators we are familiar with to ensure fast turnaround for regulatory document processing and excellence in project execution.
Once a study site is selected and approved, we continue building the site relationship with your project. Experience has shown that constant communication and training increases the sites' willingness to deliver quality data. By establishing and maintaining these site relationships, we can work with these sites on sequential studies, which results in significant time savings and cost advantages.
Every one of Paragon's Clinical Research Associates (CRAs) offers two key attributes: therapeutic expertise and clinical research experience. We seek out monitors with the best credentials in these areas because we know they are critical to the success of your trial.
Our CRAs perform clinical monitoring activities to ensure compliance to the protocol and all regulatory requirements. They also maintain strong relationships with our investigative sites to ensure successful study progress. To maximize our monitors' ability to focus on your study and produce the best results, we strive to assign them no more than two studies at a time.
Paragon provides an array of clinical monitoring services to support trials around the world. Our decentralized workforce allows us to maximize flexibility, reduce travel costs, and create an efficient and cost effective monitoring process.
Paragon's highly experienced global clinical research physicians provide the medical expertise to evaluate the safety and conduct of a clinical trial. Their support safeguards the success of a clinical trial through delivery of high quality clinical data to our customers.
At Paragon Biomedical, we know that every clinical study and program requires a thoughtful review and recommendation of the most efficient, cost-effective data capture technologies. Should your phase IV study use paper CRFs, electronic data capture (EDC), or both? Is it cost-effective to launch your phase I study using EDC?
Our data management experts will answer these questions. We offer up-front consulting on smart data capture technologies for any phase of study, indication, geography and budget. And more importantly, we draw from a broad toolbox of technologies and partnerships to meet whatever data capture needs your study may require.
We consult on and offer as part of our data management services:
Paragon offers a number of data operations solutions to meet your needs. Our data management platform is Oracle Clinical, which incorporates proprietary CRF imaging and workflow technologies for global, more efficient and cost-effective delivery of our services. Each system is fully validated and 21 CFR compliant.
Paragon provides:
DATA MANAGEMENT
PROGRAMMING/STATISTICS
Because our highly qualified global clinical research physicians bring profound understanding of the science and technology behind current initiatives, many clients have come to trust in the excellence and timeliness of our work-we're sure you will, as well.
Our global clinical research physicians offer a vast array of experience, expertise, and the enthusiasm it takes to deliver impressive reports that present your material in its strongest, most persuasive case-on time, in compliance, and with the highest quality.
At Paragon, we know that regulatory compliance is critical to every study from providing you with country selection/regulatory timeline guidance, preparation and submission management of clinical trial applications to compliance support in auditing and training services that will help ensure regulatory compliance of your clinical program.
Services:
Safety surveillance and Pharmacovigilance are crucial for subject safety and project success. Paragon's highly experienced medical and safety team have the expertise, clinical knowledge and proactive approach needed to accurately assess risks and benefits, to help our clients meet and exceed safety objectives and regulatory requirements.
If you would like more information about any of the above services, please contact us at