Clinical Trial ServicesClinquest provides all-inclusive clinical trial services. From protocol development to the final clinical study report, we support your study each step of the way. Our professional clinical trial management team will guide you through the FDA/EMEA regulations and GCP/ICH guidelines to ensure pristine data reporting for your agency submissions. Our international clinical project management staff is well equipped to provide leadership across all project disciplines to guarantee smooth communication, metric reporting management tools and team interconnected working relationships. Our medical and writing staff develops or supports your protocol design to guarantee team and site understanding of your product and clinical trial requirements. A well designed protocol leads to a successful study and most importantly, results in a well written clinical study report for presentation to the agency. Our clinical services ensure comprehensive regulatory document collection and can prepare IRB submissions on your and the sites’ behalf. Our regulatory team has a full understanding of the FDA/EMEA requirements for providing the most comprehensive and succinct report for your agency filing. Our professional international clinical site monitoring team will meet and exceed all of your expectations and ensure site compliance to your protocol. Our staff is experienced and professional and will work with your sites to ensure all data is appropriately documented and ready for any audit that may occur. We provide all the data management services you need from CRF and database design, to data cleaning and coding. Our data management group will draft a project specific Data Management Plan for your approval prior to implementing any processes. We evaluate data trends early to ensure that any challenges encountered by the sites are met in a timely manner and resolved. Our statistical group has the expertise to perform the variety of analyses your project requires, as directed by FDA/EMEA agencies, and our Statistical Analysis Plans are comprehensive and well organized. Our pharmacovigilance group provides the expertise you need to handle all medical events expeditiously and meet reporting requirements. We can also provide an independent study team for your Data Monitoring Review needs and can assist with documentation support and coordination of your meetings. Clinquest is proud of our auditing capabilities for any vendor assessments or site audits you require. Our QA staff performs diligent investigations and provides you with an all-inclusive audit plan and report. Clinical Trial Core Services:- Medical Monitoring
- Clinical Project Management
- Clinical Site Monitoring
- Site Selection
- Patient Recruitment Strategies
- Serious Adverse Event Processing
- Data Management
- Biostatistics
- Medical Writing
- Data Monitoring Reviews
- Quality Assurance and Compliance
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