Clinical trial planning & execution

Through MCRA’s regulatory, reimbursement and clinical expertise, MCRA develops and executes clinical trial plans to maneuver technologies. MCRA’s reimbursement team members are highly skilled in CTA negotiation and work directly with clients, investigators, and hospitals to reach timely arms-length agreements. Once sites identify preferred vendors of ancillary care, MCRA’s reimbursement team assists in agreements to further limit the client’s financial exposure to downstream care costs.

Projects are led by seasoned personnel who ensure smooth project execution and make sure the most appropriate resources are applied. MCRA executes clinical trials at all stages of development so that the processes foster effective decision making, optimal integration of talent, and high-value outcomes that are prudent and cost effective. MCRA provides industry leading expertise, arming clients with a competitive advantage to streamline FDA submissions and subsequent clinical trial management, FDA interactions.

  • Clinical Trial Monitoring
    Experienced in monitoring medical device trials from proof of concept to post-approval support studies

  • Data Management
    Electronic clinical processes in clinical trial technology management

  • Safety Management
    Using the latest electronic safety processes and workflow reduces processing time and risk

To contact a clinical trial expert at MCRA, call 202.552.5800 or email
info@mcra.com

MCRA is not a law firm and neither provides legal advice to its clients nor can affirm the legal or regulatory validity of the materials of which it provides. MCRA recommends that its clients consult an attorney to discuss any legal issues that relate to its business and/or MCRA services

People & Expertise

GLENN STIEGMAN

Vice President Clinical and Regulatory Affairs

Mr. Stiegman manages and directs the clinical and regulatory affairs departments for MCRA and its clients. Mr. Stiegman is responsible for management of approximately 15 clinical and regulatory professionals at MCRA. Mr. Stiegman leads the firm's submission process, regulatory strategy, analysis and development: from pre-clinical testing, to FDA submissions Read More

PH: 202.552.5803

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