IITRI
Investigate.Collaborate.Communicate
ADVANCING SCIENCE TOGETHER
10 West 35th Street. Chicago, IL 60616
extend your your scientific team
IITRI collaborates with sponsors to establish a true partnership for the planning and execution of each study. Talk to us about your program today!
IITRI
Investigate.Collaborate.Communicate
ADVANCING SCIENCE TOGETHER
10 West 35th Street. Chicago, IL 60616
extend of your scientific team
IITRI collaborates with sponsors to establish a true partnership for the planning and execution of each study. Talk to us about your program today!
Our Experience is Exceptional
preclinical development services
Over the past 40 years IITRI has established itself as a top-quality, full-service GLP-compliant preclinical contract research organization (CRO) that provides the complete IND-enabling preclinical safety and toxicology testing programs of a large CRO, with the personalized attention of a smaller organization.
We strive to establish a true partnership with our sponsors for the planning and execution of each study.
We offer accomplished study teams, with experienced and highly accessible PhD and DABT study directors having over 15 years tenure, and degreed technicians to conduct your study and provide information on study progress and early results throughout the program.
IITRI specializes in GLP toxicology and safety studies, IND-enabling programs, infectious disease vaccine and therapeutic development (including for medical countermeasures), and inhalation toxicology programs for the biotech, pharmaceutical, and government sponsors.
Drug Discovery
The successful path from preclinical drug discovery to candidate selection is a complex, iterative process that requires an integrated, interdisciplinary approach. IITRI’s experienced team of toxicologists, analytical chemists, cancer biologists, infectious disease scientists, and molecular biologists partner with sponsors to develop the appropriate preclnical testing strategy to evaluate and advance lead drug candidates towards the clinic.
We offer a range of preclinical research services including efficacy studies of drug candidates, with in vitro assays and animal models available for cancer and infectious diseases. We also work with sponsors to explore the exposure and toxicology of lead candidates utilizing pharmacokinetic analysis and non-GLP exploratory toxicology testing for risk assessment of moving forward into GLP toxicology and safety programs.
Preclinical Development
To advance new drug candidates into clinical trials, a high-quality preclinical development program that meets FDA regulatory guidelines and is managed by a team you trust is of paramount importance. IITRI’s experienced study directors work collaboratively with you to design a customized preclinical testing program that is tailored to the characteristics of your drug candidate and your timeline, and follows regulatory guidelines.
As a preclinical CRO, IITRI offers all functions of drug development studies at one location, including toxicology, pathology, and bioanalytical, for seamless management of your IND-enabling studies and programs.
Inhalation Toxicology
ITRI offers comprehensive preclinical inhalation toxicology services for development of inhaled drugs, infectious aerosol challenge studies in BSL-2 and BSL-3 containment, occupational health and environmental risk assessments, and electronic cigarette or flavor studies. Our comprehensive preclinical inhalation toxicity testing programs utilizing pulmonary drug delivery are customized to support GLP-compliant IND submissions for pharmaceuticals and the intended inhalation delivery device. We also offer early preclinical and NDA-enabling inhalation toxicology services for complete end-to-end coverage of regulatory requirements. Our laboratories are well equipped with multi-port inhalation exposure systems to perform nose-only inhalation toxicity studies on mice, rats, rabbits, canines and non-human primates (NHPs).
Toxicology
IITRI is a high-quality provider of preclinical toxicology and drug safety evaluation services in accordance with GLP standards, with over 40 years of experience partnering with pharmaceutical and biotechnology sponsors. We offer a full range of in vivo toxicology testing services to support submissions to the FDA and other regulatory agencies, including complete IND-enabling programs, and chemical toxicity assessment for pesticide or REACH registration.
IITRI offers customized acute or chronic toxicology study designs for the unique requirements of your non-GLP or GLP-compliant study goals. We also offer non-clinical toxicology studies of longer duration may be required for regulatory approval of new drugs (NDA-enabling). Studies include Maximum-tolerated dose (MTD), Dose-range finding study (DRF), Acute, subchronic and chronic toxicity studies, Repeated dose toxicity studies, Reproductive toxicology including juveniles, and Carcinogenicity studies including 2-year and 6-month transgenic mice. We can accomodate all revelant routes of adminstration and model species (including NHPs).
Biodefense and Infectious Disease
As a leading provider of infectious disease contract research services, our Molecular and Microbiology Division offers a wide range of studies for the development of new vaccines or medical countermeasures (MCMs) including the evaluating the immunogenicity, efficacy, potency, and safety of vaccines, antitoxins and therapeutics. IITRI has extensive experience in the development of vaccines against emerging infectious diseases such as COVID-19, monkeypox, Zika virus, influenza, antibiotic resistant bacteria (i.e., superbugs) and fungi (Candida sp.) or respiratory syncytial virus (RSV), which continue to pose a threat to public health both in the US and abroad. We are also highly experienced in handling bacterial or viral infectious agents that are potential bioterrorism agents when aerosolized, such as Bacillus anthracis (anthrax) and Yersinia pestis (plague), in animal challenge studies.
Bioanalytical Support
Bioanalytical (Bio-A) laboratory services are the cornerstone to the success of preclinical PK and toxicology studies, providing drug concentration analysis of dose samples, serum, fluids, and tissues. IITRI’s highly experienced team has proven success in bioanalytical method development of even the most difficult drug compounds for quantitation in complex tissues. Our GLP-compliant bioanalytical laboratory is onsite at our single Chicago, IL location for efficient and transport-free coordination of study teams and sample analysis.
We comply with FDA guidelines for bioanalytical method validation and quantitation of your small molecule or biologic in complex tissues and fluids, from preclinical studies like biodistribution to GLP-compliant IND enabling programs. We also support human clinical trial sample analysis for Phase I, II, and III trials.
NEWS AND EVENTS
Navigating Preclinical Services for Animal Rule Studies
In pharmaceutical and biotech development, there exists a regulatory pathway known as the Animal Rule or Animal Efficacy Rule. This pathway becomes essential when traditional human clinical trials are not feasible or ethical, often due to the nature of the...
Join Us at SOT 2024 in Salt Lake City!
We're gearing up for another eventful Society for Toxicology meeting in just a couple of months! You can find our team in the SOT ToxExpo exhibit hall between 9am - 4:30pm March 11-13 at Booth 901 near the entrance. We look forward to speaking with everyone there!...
ACT 2023 is Next Month!
Next month is the 44th Annual Meeting for American College of Toxicology (Nov 12-15th) at the Rosen Shingle Creek Hotel in sunny Orlando, FL. You can find us in the Expo hall at Booth #105 on Monday from 9:30am - 6:30pm and Tuesday from 8am - 6:30pm. Click here for...