Expert Medical
Monitoring
Services
Specialized medical monitoring for Psychiatry and neuroscience clinical trials. Ensuring compliance with ICH GCP, ICH E2A, ISO14155, and all international standards.
Comprehensive Medical Monitoring Services
Specialized expertise in Psychiatry and neuroscience clinical trials with full regulatory compliance
Medical Data Review & Queries
Comprehensive medical data review and generation of targeted data queries to ensure data integrity and compliance.
- Data integrity assessment
- Query generation
- Medical review protocols
Regulatory Compliance
Ensuring adherence to ICH GCP, ICH E2A, ISO14155, and all applicable national regulations and SOPs.
- ICH GCP compliance
- ISO14155 standards
- National regulations
Medical Director Support
Comprehensive support to Medical Directors with their medical monitoring activities and strategic oversight.
- Strategic oversight
- Protocol guidance
- Risk assessment
Clinical Trial Startup
Initiate medical monitoring activities during clinical trial startup with comprehensive process documentation.
- Process documentation
- Protocol alignment
- Budget planning
Medical Monitoring Plans
Development and review of comprehensive Medical Monitoring Plans tailored to specific study requirements.
- Plan development
- Risk-based monitoring
- Quality assurance
Protocol Non-Compliance
Process and address protocol non-compliances at investigative sites ensuring ethical guideline adherence.
- Compliance monitoring
- Corrective actions
- Site training
Investigator Meetings
Attend investigator meetings and interact with investigative site staff and client representatives.
- Meeting facilitation
- Site interaction
- Training delivery
Clinical Issue Resolution
Work closely with Medical Directors and sites to document and resolve clinical issues and eligibility queries.
- Issue documentation
- Resolution strategies
- Eligibility assessment
Study Documentation Review
Comprehensive review of study documentation including budgets, protocols, CRFs, and DSMB charters.
- Document review
- Protocol analysis
- Budget assessment
Protocol Design & Development
Medical input into protocol design, data collection tools, monitoring plans, and statistical analysis plans.
- Protocol design
- Data collection tools
- Statistical planning
Training & Education
Provide internal training to operational teams on diseases, drug targets, pharmacology, and protocol requirements.
- Disease education
- Protocol training
- Pharmacology guidance
Business Development
Participate in new business development activities and client relationship management.
- Client engagement
- Proposal development
- Strategic planning
About Our Medical Monitoring
As a specialized medical monitor in Psychiatry and neuroscience disorders, I bring extensive expertise in ensuring clinical trial compliance and quality. My focus is on maintaining the highest standards of medical monitoring while supporting the advancement of treatments for mental health and neurological conditions.
With deep understanding of ICH GCP, ICH E2A, ISO14155, and other international standards, I provide comprehensive medical monitoring services that ensure both regulatory compliance and patient safety throughout the clinical trial process.
Certified Expertise
ICH GCP certified with extensive experience in Psychiatry and neuroscience clinical trials
Collaborative Approach
Working closely with Medical Directors, CRAs, and investigative sites for optimal outcomes
International Standards
Ensuring compliance with global regulatory requirements and ethical guidelines
Continuous Excellence
Committed to advancing clinical research through rigorous medical monitoring practices
Areas of Expertise
Specialized knowledge and experience across Psychiatry and neuroscience clinical research
Psychiatry Disorders
Specialized monitoring for depression, anxiety, bipolar disorder, schizophrenia, and other Psychiatry conditions
Key Specialties
Neuroscience Disorders
Expert monitoring for neurological conditions including Alzheimer's, Parkinson's, epilepsy, and neurodegenerative diseases
Key Specialties
Regulatory Compliance
Comprehensive knowledge of international standards and regulatory requirements for clinical trials
Key Specialties
Protocol Development
Expert input in protocol design, statistical analysis plans, and data collection methodologies
Key Specialties
Site Management
Comprehensive site selection, initiation, and ongoing management throughout clinical trials
Key Specialties
Data Analysis
Medical review of study data, narrative summaries, and clinical study report development
Key Specialties
Get In Touch
Ready to discuss your medical monitoring needs? Let's start a conversation about your clinical trial requirements.
Contact Information
I'm here to help with your medical monitoring needs. Whether you're planning a new clinical trial or need support with ongoing studies, let's discuss how I can contribute to your success.
drshiv@gmail.com
Send me an email anytime
Phone
+1 (781) 971-6161
Mon-Fri from 8am to 6pm
Location
Global Services
Remote and on-site support
Response Time
< 24 Hours
Quick response guaranteed
Why Choose My Services?
- • Specialized expertise in Psychiatry & neuroscience trials
- • Full regulatory compliance (ICH GCP, ICH E2A, ISO14155)
- • Collaborative approach with all stakeholders
- • Proven track record in clinical trial success