Clinical Services

At Nilo Medical Consulting Group, we offer full-spectrum Clinical Research Organization (CRO) services tailored to support medical device, drug, and combination product trials. Our flexible, experienced team delivers efficient, high-quality execution—from study design to close-out—ensuring your trial stays compliant, on schedule, and within budget.

  • Our agile CRO team manages every aspect of clinical trial operations, including: 

    • Protocol writing and clinical investigational plans (CIP) 

    • Development of all supporting study documentation (CRFs, ICFs, investigator brochures, safety plans, etc.) 

    • IRB submission and oversight 

    • Site selection, contracting, budgeting, and training 

    • Site monitoring (remote and onsite) and trial oversight 

    • Management of Data Safety Monitoring Boards (DSMBs), Clinical Events Committees (CECs), and core labs 

    • Study close-out and clinical study report (CSR) writing 

    • Electronic data capture (EDC) system development and data management 

    • Biostatistics coordination and interface 

    We also coordinate effectively with other CRO partners, both domestic and international, and provide full support for IDE and IND submissions.

  • Our clinical writing team specializes in: 

    • Clinical study reports (CSR) and investigational plans (CIP) for regulatory submissions 

    • Clinical Evaluation Reports (CERs) and literature reviews 

    • White papers and peer-reviewed journal manuscripts 

    • Regulatory-ready content tailored for FDA, Notified Bodies, and international submissions 

  • We bring together regulatory and clinical expertise to support: 

    • Strategic trial design aligned with FDA and global expectations 

    • Clinical content development for submissions involving medical devices, combination products, and biologics 

    • Efficient, compliant studies that reduce unnecessary testing and accelerate timelines 

    Learn more about our Regulatory Services.

  • To ensure efficient study design, our clinical and regulatory teams provide early-stage guidance on: 

    • Bench and pre-clinical testing strategies 

    • Clinical trial justification and planning 

    • Right-sized clinical designs that meet FDA standards without overcomplication 

    • CRO execution when human clinical data is required

  • FDA interactions are pivotal. We help you prepare with: 

    • Meeting planning, facilitation, and strategic communication 

    • Development of briefing packages that clearly explain complex clinical plans 

    • Direct participation in meetings to streamline responses and secure actionable feedback 

    Our team brings experience from both industry and agency perspectives, helping you enter each meeting confident and prepared.

  • We offer training and documentation support to strengthen internal clinical systems: 

    • Good Clinical Practice (GCP) and clinical operations training (onsite or remote) 

    • Customized training in clinical, regulatory, quality, and risk domains 

    • SOP authoring and review tailored to your product and operational environment 

Let’s bring your study to life—on time, on budget, and in compliance.