Clinical trial planning & design

Clinical, Regulatory & Reimbursement planning is critical in designing any clinical study & MCRA’s team is the preeminent group to partner with. From a clinical operations standpoint, we understand the most important elements of a clinical study’s success relative to the research sites: preparation, personnel, working relationships, and patient population. MCRA also explores opportunities when developing the investigational protocol that may allow quicker time to regulatory submission and clinical study completion. This results in a meticulous study design preparing clients for a smooth transition into the Clinical Phase, avoiding protocol design and implementation process pitfalls.

Our integrated approach to clinical study design and preparation allows clients to see immediate enrollment momentum. We identify clinical study sites based on our close relationships with surgeons practicing around the country to further improve the clinical studies’ success rate. We shorten the time to regulatory approval by utilizing alternative acceptable statistical methods, expert monitoring and query management, and proper regulatory development planning. Furthermore, MCRA crafts a reimbursement strategy that eases the study sites’ administrative burden on gaining insurance reimbursement following pre-authorization and appeals processes.

  • MCRA’s integrated approach allows clients to see immediate clinical trial enrollment momentum

  • 1
    Project Management
    We manage the day-to-day activities to assure we are on schedule and within budget
  • 2
    Data Monitoring
    Committee &
    Clinical Events
    Committee (CEC)
    Provides a standard, systematic, and unbiased assessment of clinical data to determine whether it meets protocol
  • 3
    Regulatory
    We leverage data generated through mechanical, animal, or clinical testing, with unrivaled competitive knowledge, to advise or execute the regulatory pathway of your medical device technology.
  • 4
    Phase 1 Clinical
    Trial Assistance

    We design and implement the trial to determine general safety & undesirable effects of your new device

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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