Clinical Research Organization (CRO) Services
Comprehensive management of clinical trials including protocol writing, supporting documentation development (case report forms, informed consent forms, investigator’s brochure, etc.), IRB submission support, 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 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.
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.
Quality Systems & Post-Market Regulations
We provide comprehensive guidance and development of a QMS that meets 21 CFR 820 and ISO 13485 requirements, alongside risk management in compliance with ISO 14971 to lead development and V&V activities. Our expertise includes conducting regulatory change impact assessments, managing UDI requirements, resolving 483 observations, and preparing for both internal and regulatory audits.
Education
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.
Medical Writing
Nilo Medical Consulting Group is experienced in preparing Clinical Evaluation Reports (CERs), including the conduct of comprehensive literature reviews, in writing and submitting manuscripts for peer-reviewed journals, and creating white papers of clients. Our team also writes final clinical study reports (CSRs) for both IDE and NSR clinical trials for use in future regulatory submissions.
Drug & Biologic Regulatory Submissions
Our team offers services in the development and writing of comprehensive eCTD submissions for commercial Investigational New Drug (IND) studies, as well as research IND submissions. We can help you to request and prepare for pre-IND meetings to streamline regulatory processes effectively. We also support orphan drug designation requests and facilitate program development for non-clinical pharmacology and toxicology studies.