PCRI has proudly conducted over 300 clinical trials collectively from phases II to IV, across a variety of indications over the last 14 years.

Our people are our best asset. Our team boasts extensive experience and are regarded in their respective fields. PCRI success has been fueled by strong leadership and our ability to attract and retain remarkably talented, compassionate and hard-working staff members who are well-versed in federal and state regulations, good clinical practices, as well as institutional policies.

The PCRI team understands the critical role that reliable data plays in research. Our QA and Regulatory team work internally and collaborate with study monitors and auditors to maintain the highest standards from every angle. We implement rigorous site SOPs and document controls to ensure consistency across the board. Our site has successfully undergone 7 FDA inspections throughout the years, all without any major findings, alongside various sponsor audits that yielded similarly positive outcomes. We stand on integrity and transparency, because we know that it is fundamental to enhancing healthcare and ensuring the safety of our participants.

Our site has received recognition from various sponsors and CROs for outstanding performance in various trials. These accolades include awards for top enrollment, excellent retention, and overall site performance.

PCRI takes great pride in our ability to forge strong relationships with both sponsors and CRO’s, and participants, which enables us to make valuable contributions to the trials we take on.

for sponsors
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PCRI's Commitment to Quality Management &
Regulatory Excellence

PCRI understands the significance of strong quality management, and our team is dedicated to ensuring compliance by integrating quality into our clinical trials. To uphold our values of reliability and transparency, all studies are conducted with the utmost attention to safety and compliance.

In addition to sponsor audits, we frequently welcome successful regulatory inspections from agencies like the FDA.
Our site has impressively passed seven FDA inspections without receiving any 483's or needing corrective actions.

Our Regulatory and Quality Assurance (QA) team proactively work to ensure that trials are conducted according to protocol and comply with ICH, GCP, and CRF guidelines. Our goal is to ensure that sponsor data is accurate, verifiable, and compliant with regulatory standards.

We are confident in our work & data - that's why audit summaries, and inspection history can always be provided upon request.

capabilities

Phase II – Phase IV trials
Device and pharmaceutical trials
Observational and interventional studies
In-patient available (20 beds)
After hours and weekends available for participants if necessary

5 Investigators
4 Coordinators, 1 Research Assistant
4 Psychometric raters
2 Regulatory Specialists
2 IATA certified Lab Technicians
Study Start Up/Contracts and Budget Specialist
Dedicated Recruitment and Outreach Team

staff

therapeutic areas

Psychiatry
Neurology
Metabolic Diseases & Endocrinology
Pulmonology
Vaccines
Dermatology
Internal Medicine
Medical Devices
Optomology/Ophthalmology

Less than 1 mile From a Hospital
Fully Stocked Crash Cart
Back-Up Generators
CPR Certified Staff
24 hour line available for study participants
Office hours and staff available for AE evaluation when necessary

emergencies

Our site is fully prepared to conduct a wide range of studies. With an outstanding team that boasts an impressive wealth of experience, and a fully equipped facility, we are capable of adhering to any protocol. We also have established relationships with various trusted external clinics and facilities who can provide additional services such as MRI's etc. when necessary. Learn more about us and what we are equipped for below.

site amenities and details

patient access

- 3 exam/procedure rooms

- 4 rating offices

- Secure archival space for document storage

- Double locked and ground bolted storage for IP

- Fully equipped CLIA waived lab

- Ample monitoring space with room for co-monitoring

- Annually calibrated equipment

- Secure and alarmed facility

- Emergency crash cart, oxygen tank and defibrillator

- Proficient with e-Diaries/smart phones

- Inpatient facility (20 beds)

- WIFI available throughout the facility

- Conference/training rooms

- Raters certified in all rating scales with recent experience

- Familiar with most EDC and IVRS systems

- Able to use any central IRB

- Experience with managing paper patient diaries

- Familiar with Cardiac safety platforms, and imaging platforms (uploading de-identified MRI’s etc)

- Flexible availablity for PK draws etc

- Less than 1 mile to the nearest hospital

- Located near an International airport with several accomodations available

Our location in metropolitan Miami affords us an ever-expanding database of diverse participants, along with five MD investigators each running their own practices, which aid us in reaching our enrollment objectives. This effort is bolstered by a dedicated Outreach team that actively engages in research advocacy, and events within our community. At PCRI, we prioritize fostering a supportive environment for participants while striving to minimize placebo effect. Our multicultural, multilingual staff plays a crucial role in recruiting and retaining an equally diverse patient population.

Doubling down on our quest to be a reliable source of enrollment as well as quality data, PCRI uses platforms such as VCT and Dupcheck to verify patient participation in addition to other safeguards.