Background
Prior to joining MCRA, Ms. Allen was a Clinical Manager at Spinal Motion, where she worked closely with her sites and the company CRAs on two IDE studies to ensure company deadlines were met, clinical data was collected and clean in preparation for PMA submission, sites were prepared for potential FDA audits, and SOPs/GCPs were being followed at the sites.
Education
Ms. Allen has her Bachelor of Art in Psychology from American University, graduating 2005.
Experience
Ms. Allen has 13 years of experience in clinical research, spending most of her time focusing on spinal devices. She is responsible for leading, directing and providing oversight on all aspects of study execution for MCRA's CRO clients.
Ms. Allen works closely with clients, as well as MCRA's integrated regulatory, reimbursement, and statistical experts, to develop strong protocols. She also helps sponsors with choosing the most qualified and appropriate sites to participate in each study, her intimate relationship with many top spine surgeons and their study staff allows for excellent study planning and communication throughout the trial which is vital to ensuring successful study operations. Ms. Allen has worked closely with MCRA's regulatory department to assemble Clinical Events Committees (CECs), teams of qualified surgeons, and manages CEC review and adjudication of safety data collected in FDA studies. Ms. Allen has assisted the reimbursement team in developing MCRA's contract and budget division of their department to better serve our sites and continue to provide integrated services to our clients.
Overview
Ms. Allen is responsible for overseeing the CRO at MCRA. Ms. Allen is the Vice President of the Clinical Department, and assists with the day-to-day internal operations of MCRA's CRO and provides study management oversight to MCRA's CRO clients. Ms. Allen's primary therapeutic focus is on spinal device studies managed by MCRA. She serves as a primary point of contact to the sponsor for study updates and reporting as well as for any clinical issue escalation. She manages the clinical team, and develops and reviews clinical team training and deliverables. She assists clients with all types of clinical studies, from pilot to post marketing studies. The majority of the studies Ms. Allen supports are Investigational Device Exemption (IDE) studies in support of US market approval.