qclinical.com

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Quality Clinical Consulting

Study Preparation Operations/Study conduct Study Wrap up and Completion Study design Cost and timeline projection Protocol writing Clinical Advisory Boards Site selection and Qualification Study staff training Site on-boarding Essential document collection Budget and contracts Vendor selection CRF development Kick-off meetings Site Initiation visits Project management Site management Conducting monitoring visits CRA management Site audit preparations "Rescue" efforts Vendor management Medical monitoring and safety reporting Refresher training Interim analysis planning Data management oversight Data Safety Monitoring Board oversight Study payments/invoicing FDA annual reports Data quality/site audits Regulatory compliance Site Close out Medical and regulatory writing Trial Master File maintenance and archiving Publication planning and strategy ​ Clinical Strategy It is important to have a well thought-out plan for study design for your clinical trial. Q Clinical can liaise with the key stakeholders to develop a study design with endpoints to satisfy regulatory bodies, payors, and clinicians. Q Clinical will provide estimates on costs and timelines of different study designs.​ Project Management Timelines and deliverable seem to need constant managing, don't they? Let Q Clinical take the reigns. We'll work with your vendors to coordinate activities for on-time delivery of your final data set or project-specific deliverables. Clinical Monitoring The founding partners of Q Clinical are experienced with clinical monitoring for both drug and device trials. From a temporary study monitor to someone who can manage your contract monitors, Q Clinical is here to help with as little or as much as your project requires. Medical Writing Protocol writing. Regulatory reports. Scientific manuscripts. Q Clinical can provide support for all of them. From manuscripts in journals to conference posters or presentations, we will seamlessly integrate your information and help you determine where you can get the most impact from your publication. Auditing Let's face it: Some clinical study sites are simply better than others. Lying awake at night with concern over an FDA audit is no way to live. If this issue plagues you, send Q Clinical to the site. We'll work with the site staff and your current monitors to assess the situation and get things back on track.

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