Independent clinical research consultant
I am Dmytro Sydorovych, a physician with over 20 years in clinical research. I support clinical trials from feasibility and regulatory submissions through monitoring and quality oversight.
I started in clinical practice, moving from cardiology to cardiac safety. I then advanced into clinical research associate roles at international CROs. I now work as an independent clinical research consultant focused on monitoring, quality oversight, and GCP compliance. You can reach me via the contact page or through LinkedIn.
Career Summary
Сlinical foundation | 2002 – 2006
Practicing cardiologist and sub-investigator in Phase III trials.
These early assignments helped me understand how clinical trials are designed and conducted, introduced me to documentation standards, and grounded me in the core principles of not only patient care but also patient well-being and safety.
Cardiac safety | 2006 – 2009
ECG/Holter reader at GaniMed GmbH, a now-defunct niche CRO focused on cardiac safety primarily within thorough QT/QTc studies.
The role provided my first exposure to the vendor side of clinical research. I worked on internal SOP development, staff training, and supported external validation processes.
It was a practical introduction to how small service providers operate under competitive and resource-limited conditions.
Global CRO experience | 2009 – 2015
CRA at INC Research (now Syneos Health), Covance (now Fortrea), and Quintiles (now IQVIA).
My work covered the full range of CRA responsibilities: feasibility assessment, site selection, regulatory and ethics submissions, monitoring visits, and site close-out. I was also involved in CTA preparation, budget negotiation, and site payment oversight. I participated in investigator meetings, contributed to sponsor communications, and mentored junior CRAs.
In later roles, I operated with minimal supervision and reported directly to sponsors. I worked within a risk-based monitoring model for a dedicated client, using remote oversight tools and systems.
Independent consultant | 2015 – present
Clinical trials monitoring and QA. Medical writing.
Working across Phase II–IV clinical trials in oncology, psychiatry, and cardiovascular diseases. Providing full-cycle clinical operations support, safety reporting, and project oversight.
In recent years, my role has placed increasing emphasis on compliance and quality assurance. I have supported both sponsors and sites in risk-based monitoring, GCP audit preparation and conduction, documentation review, and remote or on-site quality assessments.
How I Work
- Сlear documentation and consistent processes
- Focus on protocol compliance, data traceability, and consistency between source records, CRFs, and the eTMF
- Apply risk-based review to trial records and operations
- Combine remote review with targeted on-site assessments when required
- Work independently or as part of sponsor teams
Current Focus
- Assess protocol adherence and data integrity
- Quality assurance and compliance in clinical trials
- Support GCP audits from planning to evidence review
- Prepare audit evidence packages and supporting documentation
- Track and verify CAPA implementation
- Coordinate with lead auditors and sponsors for inspection readiness
Need remote support with monitoring oversight, TMF quality control, or SOP and documentation compliance checks?