IND Enabling Services

IND-Enabling Services

Sinclair Research offers a full range IND-enabling toxicology and safety pharmacology services to help your drug development program reach the clinic and market faster.

We combine the studies you need with the customer experience you deserve to support comprehensive IND-enabling programs on your timelines and within your budget—all at our single-site research facility. Our fully customizable IND-enabling services are designed to accommodate your molecule and dose route and support your program’s specific regulatory strategy.

Sinclair’s experienced scientific team will help you successfully navigate the IND program implementation process, including conducting the pharmacokinetic evaluations you need to help determine candidate selection.

 Our IND-enabling programs include:

Sinclair Research can support a wide range of dosing routes to evaluate a wide array of test articles in standard small and large animal models in a variety of dose routes. 

Sinclair’s scientific team are experienced in testing small molecules, peptides, antibodies, proteins, antibody drug conjugates, viral vectors, cell-based and gene therapies.  

Sinclair Research can support your IND toxicology studies in both rodent and non-rodent species. Our scientific and technical staff are experienced in all nonclinical research species and follow a rigorous animal welfare program in FDA inspected and AAALAC accredited facilities. 

 

Small Animal Models: 
    • Mouse
    • Rat
    • Guinea Pig
    • Rabbit
Large Animal Models: 
    • Canine
    • Miniature Swine
    • Non-Human Primate 

Sinclair Research’s scientific and technical staff regularly conduct research in the following dosing routes. For additional and specialized routes of administration, contact our team to review your program requirements. 

  •  Aural
  • Dermal
  • Infusion
  • Intra-articular
  • Intradermal
  • Intramuscular
  • Intraperitoneal
  • Intravenous-bolus
  • Nasogastric Gavage
  • Ocular
  • Oral Gavage
  • Rectal
  • Subcutaneous
  • Transdermal
  • Transmucosal 

Toxicology

  • Dose Range Finding (DRF)
  • Maximum Tolerated Dose (MTD)
  • Acute Single dose toxicity studies
  • Subacute Repeat dose toxicity studies

Safety Pharmacology

Sinclair can support the core battery of safety pharmacology studies including: 

  • Central Nervous System (CNS)
  • Cardiovascular System
  • Pulmonary System

These evaluations detect undesirable effects of a compound on physiological functions and are required prior to human exposure as outlined in the regulatory guidance provided in ICH S7A guidelines.

Why conduct IND-enabling studies?

The U.S. FDA mandates that drug developers submit an IND application in order to determine if a new pharmaceutical’s efficacy and safety profile, manufacturing process and clinical trial design meet acceptable standards to advance to clinical trials.

An IND-enabling program compiles all the necessary regulatory information required for an IND application. After an application is submitted to the FDA, the agency has 30 days to review the application and notify the sponsor if there are any areas of concern.

The data you need. The customer experience you deserve.

Sinclair Research offers the full range of nonclinical efficacy and safety studies needed to support IND applications. These pharmacological studies consist of in vitro and in vivo studies that help to determine the efficacy and safety profile of any potential new pharmaceutical.

Throughout the course of Sinclair Research’s GLP-compliant IND-enabling studies, our dedicated study data team works in-house to ensure your data, from collection to submission, is accurately converted to SEND format. This data is recorded in SEND (Standard for Exchange of Nonclinical Data) format to accelerate submission to the FDA, as well as support faster and better-quality regulatory review.

Sinclair utilizes the following data capture and SEND dataset creation systems: 

  • Pristima® Version 7.1 or newer
  • SEND Savante ™ 7.4.0 BUILD 16

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