Clinical Research Expertise
“Clinical studies can be fraught with challenges, but unlike Contract Research Organizations (CROs), Site Management Organizations (SMOs) offer the capability to manage the most challenging work with their relationships with dedicated providers who specialize in this industry’s operational complexity.”
An On-Site Management Organization, such as National Institute of Clinical Research, Inc. drives quality enrollment, controls costs, achieves projected milestones, accommodates monitor schedules, and finishes clinical research on time.
National Institute of Clinical Research, thirty (30) years of geographic coverage and integration of research into the clinic allows for the cross-utilization of research staff and physician collaboration that ensures the success of each protocol, either isolated or shared across our multiple sites. Our Clinical Operations Leadership, quality assurance and regulatory departments ensure training and compliance among all research staff. Equally, NICR’s centralized executive administration provides simplicity and ease of contracting our multi-site network with a single point of accountability.
NICR is routinely a top performer in enrollment on projects with our Sponsors, including rare disease studies. Our success is attributed to adopting a paperless operation, which enables focus of all details to be electronically captured and tracked in real time. Our research software (CTMS), is utilized in a collaborative fashion between the following departments: medical review committee, dedicated enrollment managers, recruitment outreach team, data technology members, and quality assurance personnel.
Our experience in clinical trials is built on the foundation of our founder and owner’s own expertise in Nephrology, and started with a focus on integration of clinical research within dialysis units. NICR has translated our specialty and many years of experience into core Standard Operations Procedures (SOPs) that are suited for any research site and all indications. As the clinical research industry grew, NICR expanded from renal with the ability to service all specialities of research including, but not limited to, Internal Medicine, Immunology, and nephrotoxicity by establishing a Phase I facility.
Phase I Unit
Early phase clinical development is crucial to achieving approval for market. National Institute of Clinical Research can help set our clients up for success through our active Phase I research services. NICR provides comprehensive early phase services through our state-of-the-art facility and our highly experienced nursing team and study coordinators. NICR ensures the highest patient safety standards, an on-site pharmacy, on-site urgent care and access to all of the healthy volunteers and the diverse patient populations you need for early phase clinical trials.
We pride ourselves in our ability to retain patients from our database of volunteers and community outreach throughout the execution of our complex study trials. Our staff is trained to address the patient’s needs and concerns, and our facility provides a high level of security and comfort to our study participants.
Our Facility:
Amenities
- 10 Bed capacity
- Private rooms available
- Entertainment lounge
- Outdoor space
- Male and female restrooms
- Shower
- Lounge
- Kitchen
- Exam room(s)
- On-site lab
- On-site pharmacy
- Multilingual staff to accommodate patient population
- Extensive patient database
Equipment & Staff
The Phase I Unit is a fully functional laboratory for diagnostic testing and participant monitoring. NICR utilizes some of the most advanced equipment available for pharmaceutical research, such as:
- -70 degree Celsius freezer (Security and temperature alarmed)
- Standard centrifuges and refrigerated centrifuges
- Atomic Clock(s)
- Crash cart w/ defibrillator
- Telemetry
- ECG machines
- Pulse oximetry
- Holter Monitoring
- Secure & medical-grade refrigerated drug storage (Security and temperature alarmed)
- Backup power
Therapeutic Areas of Expertise
Nephrology
Expertise in all areas of interest, including observational, slope, CKD, ESRD, Dialysis, Transplant protocol, Post-transplant, Rare conditions, etc. Access to largest network of dialysis facilities from the top providers of dialysis and independent dialysis units.
Internal Medicine
All phase support for all cardiometabolic conditions including Hypertension, Obesity, Dyslipidemias, NASH, Diabetes, Endocrinopathies.
Infectious Diseases/Immunization
Observational, diagnostic, therapeutic, prophylactic, large-scale, fast set-up network availability for emergent Public health programs.
Experience
Past trials include:
- Post-Menopausal healthy volunteers
- Autoimmune
- Gastroenterology & hepatology
- Pulmonology
- Geriatric population studies
- First in Human
- First in class
- Food Interaction
- Pharmacokinetic
- Pharmacodynamics
- Drug Interaction
Access to Data Driven Diverse Population
NICR’s extensive data driven patient population has been developed through our patient engagement and enrollment program as well as our strong partnerships with our investigators. Our team of dedicated patient engagement specialists and our Medical Advisory Committee ensures that NICR patient reach is unprecedented for rare diseases, difficult to recruit clinical trials and rescue sites.
National Institute of Clinical Research sites are located in populous areas of Southern California, with a healthy population of volunteers from the surrounding communities. NICR also has access to diverse and special populations.
Data Technology
A clinical trial management system (CTMS) is responsible for managing all operational aspects of a clinical trial, from study startup to closeout. National Institute of Clinical Research, Inc. uses a CTMS to centralize information related to protocols, subjects, staff, financials and billing, and much more. Our CTMS acts as the hub for research operations, simplifying study conduct and improving visibility throughout a site’s research portfolio. Our CTMS is linked with other systems throughout our site(s), including eRegulatory, eIRB, EDC, participant payments, and more.
Research Operations Management
Allows NICR to manage all aspects of research from study activation through closeout, including protocol and accrual information, subject screening and activation, study calendars, and more.
Financial Management
Provides NICR with full visibility into the financial performance of studies across our research portfolio, streamlines the budgeting process, and centralizes billing designation information to ensure billing compliance.
Reporting and Analytics
Enables NICR to easily access data to confidently make strategic decisions. NICR leadership can identify trends and problem areas, and leverage actionable insights related to accrual, study activation, and effort.
As NICR conducts clinical trials that develop safe and effective treatments, it’s important to operate in a way to maximize time and resources. With so many research studies becoming more complex, using our centralized system to improve clinical trial management is essential to our continued growth, and success.
The National Institute of Clinical Research Advantage
Networked Patient Recruitment – Our network of medically trained enrollment managers, a qualified patient pool and faster follow-up to recruit and retain patients more efficiently than unsupported research sites.
Improved Data Management – With the technological infrastructure and data handling processes in place to manage both clinical and regulatory data, NICR limits delays that are otherwise commonly associated with study and regulatory data inefficiencies at unsupported sites.
Concentrated Focus for Sponsor Teams – A common pain-point that clinical research teams can face is spending more time cleaning data than analyzing data. NICR implements CTMS software so the research teams at the Sponsor/CRO have more time to analyze meaningful data.
Reduced Timelines that Control Costs – NICR provides end-to-end clinical trial-related services, from setup to, on site or remote, monitoring, a participant to compliance activities, and an engaged and thorough closeout, to shorten clinical research timelines and stick to scheduled events.
