Dolores Medical Services

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Shanna Stopatschinskaja M.D.

I am an experienced physician with an extensive post-graduate education in pharmaceutical medicine and over 15 years expertise in oncology clinical development from Phase 1 first in human trials until FDA NDA filing. I offer a full spectrum of services related to clinical research for large, mid-size and start up biopharma companies.

San Diego, +1 908 230 9327
doloresmedicalservices@gmail.com

About Dolores Medical Services

I have a passion for drug development as I am inspired by the potential to

transform groundbreaking discoveries into life-changing therapies. The dynamic

and rapidly evolving nature of oncology research captivates me, and I’m happy to

assist you as I am driven to contribute to the development of more effective,

targeted therapies that can make a positive difference in patients lives.

Our Services

We work to optimize trial planning and design, study conduct and data integrity from the beginning to the end

Protocol Development
Assistance in designing and refining the clinical trial protocol, considering the unique aspects of early-phase oncology trials.
Data Safety Monitoring Board (DSMB) Support
Facilitating the setup and operation of DSMBs to oversee the safety and efficacy of the investigational treatment.
Clinical and Safety Monitoring
Managing adverse events in compliance with regulatory guidelines. Implementing monitoring plans to ensure rapid patient enrollment.
Data Cleaning
Ensuring ongoing medical data review and generating queries.
Regulatory Writing
Providing clinical sections of key documents, including Investigators Brochures, IND summary documents, CTAs, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs.
Feasibility Studies
Conducting feasibility assessments to identify appropriate sites and patient populations for Phase 1 trials.
Project Management
Comprehensive project management services to ensure effective coordination of Phase 1 trial activities.
Patient Recruitment and Retention
Developing strategies for patient recruitment
and retention in oncology trials, considering the specific patient populations involved.