Mark Tulchinskiy Consulting, LLC

provides Regulatory-Medical-Operational (RMedOps) consulting for product development and medical affairs including medical monitoring, medical data review, medical communications and safety review for new Therapeutics (Biologics, NMEs), Med-Tech (Devices and Diagnostics)

Mark Y. Tulchinskiy, MD/ aka as “Dr. T”

Mark Y. Tulchinskiy, MD, has been in drug development field since 1990s. During his career in the pharmaceutical industry, he has held positions of progressive responsibility at Evidence CPR (currently WWCT), Pharmanet (Syneos), Medpace, Novella Clinical (IQVIA Biotech). Prior to establishing his consultancy, Dr. Tulchinskiy served as Executive Director for Clinical Development and Medical Monitoring for Humacyte. During his career Dr. T has been involved in the regulatory review or commercial launch of handful new products.
Dr. Tulchinskiy received his M.D. and training in internal medicine at the State Medical University of Kemerovo and his training in Cardiology at the Kemerovo Cardiology Center. He received his MBA from Saint Petersburg University of Economy and Finance.
Dr. Tulchinskiy is also a past member of the Kemerovo Cardiology Center IRB/IEC. He is a member of several professional societies (European Society of Cardiology since 1999 and International Society of Amyloidosis since 2016).
Dr. T

Mark Y. Tulchinskiy

Philosophy

RMedOps (Regulatory-Medical-Operational) consulting

Successful product development based upon 3 key factors:
A bright Scientific idea that addresses unmet needs; daily Operations that adheres to the highest ethical standards and flawless  processes that follows Regulatory requirements. The science must demonstrate objective experimental and unbiased clinical evidence of safety and efficacy at every stage of product development and the data should tell a compelling story. All human trials must be conducted with the highest ethical and scientific standards.  During clinical trials, the wellbeing of study subjects and data integrity must always come first, and investigational product risk-benefit ratio must be assessed 24/7 and tailored to an individual patient’ needs.  Regular advice from regulatory authorities should be sought to assure timely and successful product approval and its availability to the respective patients population.

Services

Clinical Development and Operations

Product Development
Therapeutics (Biologics, NMEs), Med-Tech (Devices and Diagnostics)
In clinical development the key is the clinical trial program that labels a product’s safety and efficacy. Clinical trials design determine everything, starting from the product approval, through prescription, marketing efforts, and ultimately the product’s return on investment. An organization’s ability to plan and execute its clinical program in a timely manner and within a budget, is the key to success.
Dr. T provides medical expertise for clinical strategy, protocol review and development, FDA meetings, sponsor interaction, presentation at investigator meetings, CRA training, data and coding review, CSR review, advisory committees, DSMBs, CECs, SRCs.

• Clinical development planning

• Clinical trial design

• Electronic data capture and edit check specs design

• Project management

• Informed consent form design/review and cultural adaptation

• Investigator and site selection selection • Medical data review and interpretation (including safety signaling)

• CRO selection/management

• Study team/Investigational site training

• Data safety monitoring board, CEC recruitment and management

Medical Monitoring and Medical Data Review.

Dr. T provides functional medical services to include Chief Medical Officer, Medical Monitor, Medical Data Reviewer, and Medical Safety Reviewer.
Safety: Data Safety Monitoring Board (DSMB), Clinical Safety Review Committee (CSR), Clinical Events Committee (CEC)
“First do no harm” is a part of the original Hippocratic oath and the principle that underlies all health care. Accurate and appropriate reporting of adverse events is the most critical task. Dr. T brings a unique and balanced perspective to the reporting of drug safety and efficacy.

• Medical monitoring

• Expedited safety reporting

• Safety review (ICSR, SUSARs)

• SAE narrative/Analysis of similar events

To Dr. T please complete the form below

Email: tulchinskiy.mark@gmail.com