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.

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). 

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).

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 (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.