FDA IND Submission Support
Operational and clinical input to prepare your IND package — including protocol review, regulatory documentation coordination, and sponsor-ready materials structured for FDA submission.
Independent clinical research consulting for biotech sponsors
From IND preparation to site closeout — hands-on support at every step.
Dr. Boris Nikolov provides direct, expert-level consulting to biotech companies launching clinical trials. Whether you need help preparing your FDA IND submission, identifying the right research sites, contracting investigators, or managing on-site monitoring through final closeout — he can step in where you need it most.
- 134
- Completed studies
- 120+
- PI, Sub-I, and Rater trials
- 20%+
- Operational delay reduction cited in CV
Consulting services
End-to-end support from IND filing to final data submission.
Each service covers a distinct phase of the clinical trial lifecycle — so you can engage Dr. Nikolov for the full program or bring him in for the specific piece you need help with.
Site Identification & Feasibility
Help with site network identification, design feasibilities, and evaluation of prospective sites.
Contracting & Study Start-Up
Manage the full contracting sequence — from initial confidentiality agreements and protocol distribution to investigator contracting, site activation, and delegation planning.
On-Site Monitoring & Closeout
Supervise study execution through regular on-site monitoring visits, protocol compliance checks, and issue resolution — through to the final termination visit and data cleaning for FDA submission.
How it works
Direct, flexible consulting — no agency overhead, no handoffs.
Engage for the full program or a single phase.
Whether you need end-to-end trial support or just help getting through site feasibility and contracting, Dr. Nikolov works with your timeline and scope — not a fixed retainer structure.
Confirm sites are actually ready before you sign.
Site selection isn't just about interest — it's about confirming the right patient population exists, the staff have capacity, and the site can meet your protocol requirements before contracting begins.
Stay on-site through closeout.
Monitoring doesn't stop at visit scheduling. The work continues through protocol adherence checks, query resolution, and a clean termination visit that leaves data ready for FDA review.
Evidence from the CV
Three decades across CNS and multi-therapeutic clinical research.
134
Completed studies
30%
Study efficiency improvement through workflow redesign and team enablement
101
Monitoring visits as a Clinical Research Associate
3
Trilingual: English, Spanish, and Bulgarian
Expertise
Clinical operations depth with CNS specialization.
Clinical Operations
Study start-up, site selection, site activation, clinical trial management, recruitment support, visit execution, and cross-functional coordination.
Quality and Compliance
ICH-GCP, FDA, EMA, IRB/IEC coordination, RBM/RBQM, CAPA, deviations, ALCOA+ data integrity, TMF/eTMF oversight, and audit readiness.
Systems and Data Flow
EDC including InForm and RedCap, IRT/IWRS, eCOA/ePRO, CTMS, eConsent, J-Review, query management, KPIs, and operational reporting.
CNS and Medical
CNS rating scales, psychometric ratings, medical oversight support, AE/SAE documentation support, protocol review, and subject-safety workflows.
Selected experience
Roles spanning sponsor-facing operations, site leadership, and clinical monitoring.
Director of CNS Research, Rovia Clinical Research
Led Phase I-III CNS portfolio execution, reinforced audit readiness, supported AE/SAE review workflows, and improved timeline predictability for sponsor partners.
Site Director, International Medical Investigation Clinics
Executed CNS and multi-therapeutic studies across 120+ trials, with responsibility for protocol discipline, sponsor-ready data flow, and study team routines.
Department Manager of Clinical Research, Akta Medika
Managed 75 clinical trials across 21 therapeutic areas while coaching 24 staff members toward repeatable GCP-ready operating practices.
Clinical Research Associate, PSI CRO AG
Conducted 101 monitoring visits, identified site risks early, issued clear action items, and supported timely finding closure.
Professional activities
Selected publications and activities listed in the CV.
Presented conservatively from the resume until individual publication links are verified.
- Nature Medicine (2025) - Allogeneic mesenchymal stem cell therapy with laromestrocel in mild Alzheimer's disease.
- Journal of Infectious Diseases (2023) - SAB-185 polyclonal antibody therapy, Camostat phase 2 trial, and Amubarvimab/Romlusevimab study.
- Frontiers in Aging (2023), Nature (2021), Alzheimer's Research & Therapy (2021), and Journal of Prevention of Alzheimer's Disease (2020).
- Conference presentation (2023) - Post-acute sequelae of SARS-CoV-2.
Get in touch
Tell Dr. Nikolov about your trial — he'll tell you if and how he can help.
Whether you're early in IND planning or already struggling mid-study, reach out directly. No intake forms. No sales team. Just an experienced clinical research professional who can quickly assess where you need support.