Clinical

Our areas of clinical focus include Oncology, Cardiology, Neurology, Rheumatology, Orthopedics, Gynecology, Oral Health, Infectious Disease, and Pediatrics/Neonatology. When dealing with a large clinical trial firm, it can feel that you’ve been overwhelmed by a wave of people and costs. At MBCA, we can easily integrate into your organization and provide as much or as little guidance as you need. We always offer “right-sized” consulting based on your needs.

Clinical Research Protocol Design

MBCA can help you with any aspect of your clinical trial design and execution. We’ll help you design your study and then run it from the first submission to the final report.

Clinical Trial Monitoring

Put your clinical trial on auto-pilot by taking advantage of our clinical trial monitoring services.

Institutional Review Board / Ethics Committee Negotiations Quisque rutrum. Aenean imperdiet. Etiam ultricies nisi vel augue. Curabitur ullamcorper ultricies nisi.

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Clinical Trial Audits

MBCA will support your clinical trials by providing independent clinical trial audits that you can rely on. With our staff of qualified clinical trial auditors, we can support virtual, on-site, or hybrid audits in a turnkey, efficient, and cost-effective way, for as long as you need us.

Medical Writing

Creating documents for clinical research studies and regulated products requires a special combination of knowledge of the product and related regulations and the ability to write with clear, concise language. We can provide a combination of that knowledge and those writing skills to help generate documents that meet the requirements of the FDA or the EU MDRs and that are well-written and usable.

GCP Training

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Institutional Review Board / Ethics Committee Negotiations

Clinical Trial Audits MBCA will support your clinical trials by providing independent clinical trial audits that you can rely on. With our staff of qualified clinical trial auditors, we can support virtual, on-site, or hybrid audits in a turnkey, efficient, and cost-effective way, for as long as you need us.

Selection of Clinical Research Organizations

Medical Writing Creating documents for clinical research studies and regulated products requires a special combination of knowledge of the product and related regulations and the ability to write with clear, concise language. We can provide a combination of that knowledge and those writing skills to help generate documents that meet the requirements of the FDA or the EU MDRs and that are well-written and usable.

Clinical Project Schedules and Budgets

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Need Immediate Assistance? Have you received a regulatory notice or a major finding during your ISO audit? We can help you respond and quickly formulate corrective actions to prevent further disruption to your business. Get Assistance

Upcoming Inspection or Audit? Leverage our decades of experience by letting us help you confidently prepare for your inspection or audit. Get Started

Taking your first product to market?

We can help you navigate the maze of regulations and avoid common mistakes. Need a Regulatory Strategy? We can help. Need your first Quality Management System? Ask us about IntelaSolve eQMS. Contact Us

Contact our experts How can we help?

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Need Immediate Assistance?

Have you received a regulatory notice or a major finding during your ISO audit? We can help you respond and quickly formulate corrective actions to prevent further disruption to your business.

Get assistance ›

Upcoming Inspection or Audit?

Leverage our decades of experience by letting us help you confidently prepare for your inspection or audit.

Get started ›

Taking your first product to market?

We can help you navigate the maze of regulations and avoid common mistakes. Need a Regulatory Strategy? We can help. Need your first Quality Management System? Ask us about IntelaSolve eQMS.

How can we help?

Tell us what you are working on and we will point you at the fastest route to compliance.

Schedule a free consultation