Ophir Clinical Research
Advancing Clinical Research With Integrity and Precision
Investigator-led Phase II–IV clinical trial site delivering compliant, patient-centered study operations for sponsors and CROs.
ABOUT US
Advancing Research Through Expertise and Care
Ophir Clinical Research is an investigator-led clinical research site dedicated to the successful execution of Phase II–IV clinical trials. We work closely with sponsors and CROs to deliver reliable site performance, regulatory compliance, and high-quality clinical data.
Our team is committed to conducting research with integrity, precision, and patient safety at the forefront. From study start-up through close-out, we follow ICH-GCP–compliant processes to ensure ethical study conduct, accurate data collection, and inspection readiness at every stage.
By combining strong medical oversight with efficient site operations and participant-focused care, Ophir Clinical Research serves as a dependable partner in advancing clinical development.
Services
Services We Offer
Study Operations & Site Management
End-to-end operational support for Phase II–IV clinical trials, including study start-up, conduct, and close-out. We ensure efficient execution while maintaining data integrity and regulatory compliance.
Medical Oversight & Safety Monitoring
Investigator-led medical oversight with continuous safety monitoring. Our team ensures protocol adherence and timely identification and reporting of adverse and serious adverse events.
Regulatory & IRB Support
Comprehensive regulatory management in alignment with ICH-GCP standards, including IRB submissions, amendments, continuing reviews, and maintenance of essential regulatory documentation.
Participant Recruitment & Retention
Ethical and targeted recruitment strategies, participant screening, and retention planning to support enrollment goals and visit compliance throughout the study lifecycle.
WHY CHOOSE US
A Dependable Partner in Clinical Development
Ophir Clinical Research provides sponsors and CROs with a reliable, investigator-led site committed to regulatory excellence, accurate data collection, and timely study execution. Our structured approach and patient-first mindset support both study performance and long-term partnerships.
Investigator-Led Medical Oversight
Every study is conducted under direct Principal Investigator leadership, ensuring consistent medical oversight, safety monitoring, and protocol adherence.
ICH-GCP–Compliant Operations
Our processes are fully aligned with ICH-GCP guidelines, supporting ethical study conduct, regulatory compliance, and inspection readiness at all times.
Inspection-Ready Documentation
We maintain complete and accurate source documentation, regulatory binders, and EDC records ensuring smooth monitoring visits, audits, and inspections.
PROCESS
A Structured, Compliant Approach to Clinical Research
STEP 01
Study Start-Up
Feasibility, regulatory submissions, and site activation conducted in compliance with ICH-GCP guidelines to ensure a smooth study launch.
STEP 02
Study Conduct
Protocol-driven study visits, participant management, safety monitoring, and accurate data collection throughout the trial lifecycle.
STEP 03
Study Close-Out
Timely data reconciliation, regulatory documentation completion, and inspection-ready close-out support for sponsors and CROs.
TESTIMONIALS
What Our Partners Say
FAQS
Frequently Asked Questions
1. What types of clinical trials does OPhir Clinical Research support?
Ophir Clinical Research supports Phase II–IV clinical trials across a range of therapeutic areas, working closely with sponsors and CROs to ensure compliant and efficient study execution.
2. Is Ophir Clinical Research ICH-GCP compliant?
Yes. All studies are conducted in accordance with ICH-GCP guidelines, with established procedures to support regulatory compliance, participant safety, and data integrity.
3. How does Ophir ensure participant safety?
Participant safety is overseen by the Principal Investigator and experienced research staff through continuous monitoring, protocol adherence, and timely reporting of adverse and serious adverse events.
4. Does Ophir Clinical Research assist with participant recruitment?
Yes. We support ethical participant recruitment, screening, and retention strategies aligned with protocol requirements and regulatory standards.
5. How does Ophir handle regulatory and IRB submissions?
Our team manages IRB submissions, amendments, continuing reviews, and maintains complete regulatory documentation throughout the study lifecycle.
1. Are monitoring visits and audits supported on-site?
Yes. Ophir Clinical Research is fully prepared to support monitoring visits, audits, and inspections, with accurate source documentation and inspection-ready records.
2. How is investigational product (IP) managed?
Investigational products are received, stored, dispensed, and documented according to protocol requirements, with temperature monitoring and full accountability maintained at all times.
3. Who can participate in clinical trials at OPhir Clinical Research?
Eligibility depends on the specific study protocol. Potential participants are screened to ensure they meet all inclusion and exclusion criteria before enrollment.
4. How can sponsors or CROs initiate collaboration with OPhir Clinical Research?
Sponsors and CROs can contact our team directly to discuss feasibility, site capabilities, and study requirements.
5. Where is Ophir Clinical Research located?
We are located at 1110 Cottonwood Lane, Ste 160, Irving, TX 75038.