Scantox
Scantox offers biocompatibility testing services, leveraging extensive archives of biomedical and life sciences literature for research and compliance.
Scantox provides specialized biocompatibility testing, drawing upon a vast digital archive of biomedical and life sciences journal literature. This resource, maintained by the U.S. National Institutes of Health's National Library of Medicine (NIH/NLM), ensures access to centuries of scientific research crucial for understanding and validating the safety of medical devices and materials. Our services are designed to support organizations in navigating the complexities of regulatory compliance and scientific validation. By utilizing comprehensive data and research, Scantox aims to deliver reliable and accurate biocompatibility assessments, contributing to the advancement and safety of life sciences innovations.
About
**Who they are**
Scantox is a Contract Research Organization (CRO) specializing in toxicology and preclinical research, dedicated to supporting clients through the drug development process. They emphasize efficiency and close collaboration to facilitate the transition to first-in-human studies.
**Expertise & scope**
* Offers a comprehensive suite of services for Investigational New Drug (IND) applications, including lead candidate optimization, toxicity, and safety testing.
* Provides general toxicology studies in both rodent and non-rodent species, including Maximum Tolerated Dose (MTD) and Dose Range Finding (DRF) studies, as well as repeat-dose toxicity studies (e.g., 4-week, 13-week, 26-week, and 39-week studies).
* Conducts juvenile toxicology studies in minipigs to assess drug safety for pediatric trials, adhering to FDA and EMEA guidelines.
* Performs embryofetal toxicology studies, including Fertility and Early Embryonic Development (FEED) studies, following international ICH guidelines.
* Offers specialized services such as regulatory toxicology, safety pharmacology, bioanalytical testing, and drug formulation.
* Maintains a fully equipped clinical pathology laboratory for hematology, biochemistry, coagulation, and urinalysis, validated for relevant species.
**Reputation / proof points**
* Leverages decades of in-depth experience in key service areas.
* Supports GLP-compliant phases for preclinical programs.
Scantox is a Contract Research Organization (CRO) specializing in toxicology and preclinical research, dedicated to supporting clients through the drug development process. They emphasize efficiency and close collaboration to facilitate the transition to first-in-human studies.
**Expertise & scope**
* Offers a comprehensive suite of services for Investigational New Drug (IND) applications, including lead candidate optimization, toxicity, and safety testing.
* Provides general toxicology studies in both rodent and non-rodent species, including Maximum Tolerated Dose (MTD) and Dose Range Finding (DRF) studies, as well as repeat-dose toxicity studies (e.g., 4-week, 13-week, 26-week, and 39-week studies).
* Conducts juvenile toxicology studies in minipigs to assess drug safety for pediatric trials, adhering to FDA and EMEA guidelines.
* Performs embryofetal toxicology studies, including Fertility and Early Embryonic Development (FEED) studies, following international ICH guidelines.
* Offers specialized services such as regulatory toxicology, safety pharmacology, bioanalytical testing, and drug formulation.
* Maintains a fully equipped clinical pathology laboratory for hematology, biochemistry, coagulation, and urinalysis, validated for relevant species.
**Reputation / proof points**
* Leverages decades of in-depth experience in key service areas.
* Supports GLP-compliant phases for preclinical programs.
Additional information
Scantox supports various routes of administration for toxicology studies, including oral (gavage, capsules, diet), dermal, intramuscular, subcutaneous, and intravenous. They can fit animals with vascular catheters for easier dosing or blood sampling. For clinical pathology, they analyze samples from studies performed at Scantox facilities and also offer analyses on samples from studies conducted at client facilities. They are equipped to implement and validate new clinical pathology tests in cooperation with clients.
Key Highlights
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Offers comprehensive toxicology services for IND-enabling studies, including lead optimization, toxicity, and safety testing.
Source
“providing a comprehensive suite of services for IND applications. This includes everything from lead candidate optimization, toxicity, and safety testing to bioanalytical testing and dose formulation.”
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Conducts juvenile toxicology studies in minipigs to assess drug safety for pediatric trials, adhering to FDA and EMEA guidelines.
Source
“According to FDA and EMEA guidelines, juvenile animal toxicity studies are mandatory when existing data cannot confirm a drug’s safety for pediatric trials.”
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Performs embryofetal toxicology studies, including Fertility and Early Embryonic Development (FEED) studies, following international ICH guidelines.
Source
“Scantox provides three developmental and reproductive toxicology (DART) study types. They adhere to international ICH guidelines (e.g., ICH S5(R3)) for drug safety assessments.”
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Provides a fully equipped clinical pathology laboratory for hematology, biochemistry, coagulation, and urinalysis, validated for relevant species.
Source
“Included in the Scantox laboratory set up is a fully equipped clinical pathology lab, set up to enable analyses of all standard tests/biomarkers within hematology, biochemistry, coagulation and urinalysis...”
Certifications & Trust Signals
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Operates as a Contract Research Organization (CRO) with expertise in toxicology and preclinical research.
Source
“As a leading CRO in toxicology and preclinical research, we prioritize efficiency and close collaboration with our clients...”
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Supports GLP-compliant phases for preclinical programs.
Source
“Scantox supports the design, execution, and management of preclinical juvenile programs from exploratory to GLP-compliant phases.”
Buyer Snapshot
Best for
- Companies requiring comprehensive preclinical toxicology testing for IND applications.
- Sponsors developing drugs for pediatric populations.
- Organizations needing specialized embryofetal toxicology assessments.
How engagement typically works
- Collaborative partnership
- Integrated project management
- Extension of client's team
Typical deliverables
- Toxicology study reports (MTD, DRF, repeat-dose, juvenile, embryofetal)
- Clinical pathology analysis reports
- IND-enabling study packages
- GLP-compliant study documentation
Good to know
- Best when requiring GLP-compliant preclinical toxicology services.
- Best when needing specialized studies for pediatric or reproductive safety assessments.
HQ:
US
Languages:
English
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Industries:
Medical Devices
Pricing model:
Custom pricing
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, USP <87>, USP <88>
Test Types Offered:
Cytotoxicity, Genotoxicity, Systemic toxicity, Implantation, Hemocompatibility, Biodegradation
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Toxicology Capabilities:
Scantox offers a comprehensive suite of toxicology services, including in vitro and in vivo testing, to support medical device development and regulatory submissions. Their expertise covers a wide range of toxicological endpoints, ensuring thorough evaluation of device safety.
Lead Time Band:
Start in 4-8 weeks
Quote SLA:
3-5 business days
Rush Available:
Yes
Sample Requirements:
Samples must be sterile and provided in appropriate containers. Specific quantities and preparation methods will be communicated based on the tests requested.
Sample Return Policy:
Both options
Nda Support:
Yes
Minimum Project Size:
$25-50k
Regions Served:
North America, Europe, Asia
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ICH guidelines (e.g., ICH S5(R3))
Test Types Offered
Toxicology studies (MTD, DRF, repeat-dose, chronic, juvenile, embryofetal), Clinical pathology (hematology, biochemistry, coagulation, urinalysis), Safety pharmacology, Bioanalytical testing, Drug formulation
Contact Types Supported
N/A
Duration Types Supported
Short-term (7 days - 2 weeks), 28 days (4 weeks), 13-week (3-month), Chronic (6-12 months, 26-weeks, 39-weeks)
Lead Time Band
Start in 0-2 weeks, Start in 2-4 weeks, Start in 4-8 weeks, Start in 8-12 weeks, Start in 12+ weeks
Quote SLA
3-5 business days
Sample Return Policy
Dispose
Minimum Project Size
Custom
Pricing Model
Custom
