Clinical Research Organization (CRO) Services
Our agile yet robust CRO team provides comprehensive management of clinical trials including protocol writing, development of supporting documentation (case report forms [CRFs], informed consent forms [ICFs], investigator’s brochure, monitoring plans, safety management plan, etc.), IRB submission support, site selection, contract and budget negotiation, site start-up and training, monitoring and trial oversight, as well as study close-out and clinical study report writing. We manage data safety and monitoring boards (DSMBs), clinical events committees (CECs), safety oversight and core laboratories for clinical trials. Our team develops and manages electronic data capture (EDC) systems, supports data management functions, and can manage and/or coordinate and interface with the biostatistics requirements for the trial.
We also oversee and coordinate with other CROs both domestically and internationally, and handle IDE and IND submissions, ensuring compliance and efficient trial conduct.
Medical Writing
Nilo Medical Consulting Group (NMCG) is experienced in writing clinical investigational plans (CIP) and clinical study reports (CSRs) for both IDE and NSR clinical trials for use in regulatory submissions. Our team prepares Clinical Evaluation Reports (CERs), including the conduct of comprehensive literature reviews. NMCG writes and submits manuscripts for peer-reviewed journals, and creates white papers for clients.
Medical Device, Combination Product, and Drug & Biologic Regulatory Submissions
Our clinical and regulatory teams provide specialized support for the clinical study components of submissions for medical devices, combination products, and drugs and biologics. We assist with both submission writing and clinical trial design. By ensuring studies are designed efficiently, compliantly, and appropriately from the outset, we help our clients save significant time and resources. Learn more about these types of submissions.
Verification & Validation Testing Requirements
Our regulatory and clinical teams provide strategic guidance on bench performance, pre-clinical and clinical testing to ensure the right studies are conducted from the outset—meeting FDA requirements, regulatory standards, and compliance expectations without unnecessary overdesign. When clinical testing is needed, our full-service Clinical Research Organization (CRO) supports efficient, appropriately scoped study design that aligns with regulatory objectives while optimizing for client budgets and timelines.
FDA Meetings
We know that approaching the FDA can be an intimidating prospect. Meetings are limited in time and need to sufficiently explain complex issues. We have experience on both sides of the table and can facilitate meetings as well as advise companies on the best way to get the most useful information from any FDA interaction.
Having our clinical support team assist in authoring the materials that are submitted in advance and attend these meetings helps facilitate effective communication of clinical study plans and trial designs as well as obtain needed feedback from the FDA efficiently and successfully.
Education & SOP Development
All-encompassing staff training in regulatory, quality, risk, and clinical requirements, conducted either remotely or onsite, tailored specifically to your unique products and operational needs. Additionally, specialized Good Clinical Practice (GCP) training ensures adherence to global standards in clinical research conduct. Our team is equipped to author and/or review client SOPs in the clinical, quality, regulatory and risk management domains.