Our Services
Our commitment to excellence means providing full transparency to sponsors while leveraging cutting-edge technology and expertise to ensure successful trial outcomes.
Clinical Trial Management
We oversee every aspect of the clinical trial process, from start to finish, to ensure that studies are executed efficiently and effectively. Our hands-on management approach aims to meet key milestones while maintaining the highest standards of quality and reliability.
Benefits
- Streamlined Operations: With our comprehensive project management strategies, challenges are addressed proactively, ensuring the trial stays on schedule and within budget.
- Regulatory Confidence: We ensure strict compliance with international, federal, and local guidelines, giving sponsors the peace of mind they need to focus on their research outcomes.
- Optimized Collaboration: Seamless coordination between sponsors, investigators, and clinical sites ensures everyone is aligned toward achieving trial objectives.
Service
Our commitment to excellence means providing full transparency to sponsors while leveraging cutting-edge technology and expertise to ensure successful trial outcomes.
Study Design and Consultation
Our team offers expert consultation for developing well-designed, scientifically robust study protocols tailored to the unique needs of your research. A strong study design is the foundation of generating reliable and actionable data.
Benefits
- Customized Protocols: Every study is carefully designed to meet the specific goals of the sponsor while adhering to scientific and ethical standards.
- Higher Success Rates: With precise protocols in place, trials have a better chance of yielding valuable insights and achieving their research objectives.
- Cost and Time Efficiency: A solid design minimizes delays and unnecessary expenses by identifying potential issues early.
Service
Our seasoned experts work closely with you to understand your vision, ensuring that every protocol is meticulously crafted to deliver the most meaningful outcomes.
Patient Recruitment and Retention
Recruiting eligible participants and retaining them throughout the trial are critical for the success of any study. We employ specialized, targeted strategies to ensure diverse, qualified participant enrollment and sustained engagement.
Benefits
- Improved Patient Engagement: By prioritizing participant needs and safety, we maintain high engagement rates while offering clear communication and support throughout the process.
- Faster Recruitment: Efficient recruitment reduces delays, helping projects progress to the next phases quickly.
- Data Integrity: By reducing participant dropouts, we generate more consistent and comprehensive data.
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Service
Our team uses data-driven approaches, including digital outreach and community engagement, to recruit participants who meet the exact criteria for your study while maintaining a participant-friendly experience.
Regulatory Compliance and Reporting
We ensure every study adheres to ethical, regulatory, and legal requirements at every stage, from Institutional Review Board (IRB) approvals to ongoing reporting requirements.
Benefits
- Risk Mitigation: Stringent compliance minimizes legal and ethical risks.
- Simplified Processes: Our expertise streamlines navigating complex regulatory environments, saving you time and effort.
- Confidence in Approval: Adherence to guidelines ensures timely approvals from relevant authorities, avoiding unnecessary delays.
Service
Our team stays current on global regulations, keeping your study in compliance with changes in policies or standards. With our meticulous reporting processes, you’ll always be ahead of the curve.
Data Collection and Analysis
We leverage state-of-the-art technology to collect accurate, real-time data while ensuring its integrity and reliability. Analysis is tailored to reveal actionable insights that align with trial objectives.
Benefits
- Accurate Decision-Making: Comprehensive and detailed statistical analysis provides deeper insights into trial outcomes.
- Enhanced Data Security: We use robust systems to safeguard sensitive trial information.
- Real-Time Updates: Access to current, real-time data allows you to make informed decisions throughout the study.
Service
Our expert statisticians and data scientists closely monitor the entire data lifecycle, ensuring it is handled with the highest level of precision.
Pharmacovigilance
We provide vigilant safety monitoring to protect participants and address any adverse events during the trial. Prioritizing participant well-being is crucial for maintaining the integrity and success of your research.
Benefits
- Participant Safety: Immediate detection and reporting of adverse events prevent serious complications.
- Regulatory Confidence: Adherence to pharmacovigilance reporting requirements ensures continued compliance.
- Risk Reduction: Thorough monitoring reduces liability and builds credibility for your clinical study.
Services
We offer end-to-end safety solutions led by experienced professionals who prioritize both participant safety and the study’s success.
Investigator and Site training
Proper training guarantees that investigators and study staff fully understand study protocols, ethical considerations, and regulatory requirements. This ensures the highest quality of trial operations.
Benefits
- Improved Compliance: Properly trained staff reduce errors and ensure adherence to best practices.
- Team Confidence: Training fosters competence, confidence, and collaboration among study teams.
- Enhanced Participant Experience: Well-trained teams provide better care and communication, keeping participants satisfied and engaged.
Services
Our training sessions are thorough, interactive, and tailored to meet the specific needs of each study, creating a professional and competent trial environment.
Medical Writing and Documentation
We provide expert medical writing services to produce clear, concise, and fully compliant documentation, including clinical trial reports, study protocols, and regulatory submissions.
Benefits
- Regulatory Readiness: All documentation is prepared to meet the standards required for submissions to regulatory authorities.
- Clarity and Precision: Professionally crafted documents leave no room for ambiguity, ensuring consistent communication of study findings.
- Accelerated Approvals: Well-organized and expertly written documents expedite the review process.
Service
Our medical writers combine technical expertise with attention to detail to deliver documentation that upholds the highest scientific and regulatory standards.
Meet Our Doctors
Together, their expertise and dedication drive the success of our trials, ensuring precision, innovation, and ethical excellence at every step of the process.
Their leadership is integral to delivering impactful outcomes that advance healthcare and improve patient lives.
Nora Carmenates
Office Manager
Alberto Carmenates
Clinical Research Coordinator
Dr. Robert Hernandez
Principal Investigator
OUR OFFICES
