 |
|
|||||||||||||
|
||||||||||||||
 |
 |
ClinTech Research provides preclinical drug development outsourcing services that include Toxicology and Pharmacology contract research through a network of vendors that include internationally recognized research institutions and GLP-accredited Preclinical CROs primarily in India and in the USA. We offer both GLP-compliance regulatory toxicology studies for Investigational New Drug (IND) application as well as non-GLP toxicology and pharmacology studies in order to provide preliminary assessment of a drug's safety and efficacy.
ClinTech Research's contract research is performed under a Fee For Service model. We provide access to state-of-the-art animal facilities and leading research experts for our clients. We have all underlying contracts, such as IP and confidentiality agreements, with our preclinical partners already in place. We can quickly start projects, saving significant time and manpower resources to our sponsors.
ClinTech Research is an independent CRO, and do not broker/represent CROs, or receive fees, or kickbacks from CROs. Our selection of CROs for clients is driven by a business philosophy to identify the right CRO to fit the client's needs for the particular task at hand. We offer following preclinical drug development outsourcing services
|
|
Once a drug candidate is identified, we help develop and manage the appropriate preclinical safety
evaluation program that include pharmacology, pharmacokinetics, safety pharmacology & toxicology
to support the conduct of First-in-Human clinical trials IND submission, and subsequently NDA/BLA
We are dedicated to ensure the smooth progress of nonclinical programs in accordance with your needs and regulatory requirements and we will partner with you to create solutions that are specially tailored to meet your needs.
Our preclinical development services include:
We are dedicated to ensure the smooth progress of nonclinical programs in accordance with your needs and regulatory requirements and we will partner with you to create solutions that are specially tailored to meet your needs.
Our preclinical development services include:
- Develop preclinical outsourcing proposal, design preclinical management programs including study design, protocol generation and vendor selection
- Manage client/vendor relationships by monitoring vendor progress and keeping client informed, including troubleshooting technical issues
- Managing & monitoring Preclinical Safety programs in India
- Prepare, review, and edit the preclinical Study reports
- Pathology/Histopathology support services by western Board-certified pathologists for studies conducted at Indian CROs
- Pre-Clinical Study Analysis and Interpretation, including identifying additional study needed for go/no go decision-making
- Prepare preclinical section of an IND packages for US regulatory submissions.
If you have any questions or would like a more detailed description of our preclinical development services, please Contact Us.
