Toxicology

...Proven Science. Experienced People. Trusted Results.

Since 1968, Southern Research has been conducting preclinical safety assessment evaluations for both small molecules and biologics.

Our toxicologists are backed by a highly trained technical staff including on-site histopathology and clinical pathology and robust systems for data capture and management. We are committed to providing the highest quality, regulatory-compliant toxicology services. Our staff average more than 15 years of industry experience including 8 years at Southern Research.

We strive to execute the most appropriately designed studies to make the path to regulatory approval as smooth as possible.

Veterinary Services and Laboratory Animal Resources

As added value for our clients, Southern Research's veterinary program ensures a highly interactive and dynamic relationship between veterinary staff and study directors. With 35 years of experience in laboratory animal research, including 29 years in toxicology and infectious diseases, our veterinary staff works closely with both study directors and business development managers. Study directors have 24-hour access to veterinary consultation which ensures the highest level of clinical support.

We have a newly renovated experimental surgery suite and experience in:

• Laproscopy
• Deposition and ablation models
• Stereotaxic dosing
• Intralumenal dosing

Southern Research has the flexibility and expertise to develop new techniques and procedures to meet our clients' timelines.

Pathology Services - Anatomical and Clinical

Southern Research's Pathology Services consist of an experienced team of ACVP board-certified veterinary pathologists, ASCP-certified histology and clinical pathology technicians, and AALAS-certified necropsy prosectors involved in the evaluation of pathological changes critical to the assessment of acute, subchronic and chronic toxicity studies. The Pathology Services team members have an average of 16 years of industry experience.

The Clinical Pathology Laboratory uses state-of-the-art equipment that is capable of high-throughput testing and is configured to run species-specific testing. Throughout Pathology Services, all data is collected electronically using Provantis.

Bioanalytical Sciences

Southern Research has complete Bioanalytical support including:

• Method development and validation for small and large molecules
• In vitro metabolism
• RT-PCR, qPCR
• Proteomics using 2-d gel and MALDI-TOF

Support Services

• Quality Assurance - QA at Southern Research has been continually assessing the compliance of the organization with Good Laboratory Practices (GLPs) since 1979. QA reports to Senior Management through the Director of Compliance and Safety, and is totally independent of the conduct of the regulated studies. All members of QA are active in the Society of Quality Assurance, and most hold certification as Registered Quality Assurance Professionals in GLPs. In addition, all auditors have prior experience in a related technical field prior to joining QA which enhances their understanding of the data and processes that they are auditing.
• Project Management - Our team has an average of more than 25 years of experience in executing successful projects. The team is responsible for ensuring the timely initiation and completion of all studies.
• Study Coordination - Our team compiles all data and assists in report preparation. This dedicated group of professionals works closely with study directors to prepare high-quality study reports.
• Archives - Southern Research has a secure on-site facility for storing wet tissues, slides, blocks, and paper data.
• Document Control - Southern Research uses Documentum Compliance Manager (DCM) to store revise, approve, and distribute Standard Operating Procedures and Controlled Forms in a 21 CFR Part 11 compliant system.
• Environmental Monitoring - Southern Research is equipped with the Edstrom Watchdog Environmental Monitoring System that constantly monitors and collects environmental data in the animal laboratories and associated areas. The system's alarm capability ensures prompt evaluation and warranted correction of environmental excursions.
• Data Collection - At Southern Research, we utilize the Provantis (Instem) system for in-life, clinical pathology, and pathology data collection. The software is 21 CFR Part 11 compliant.
• Data Sharing - For sharing data with our clients in a secure environment, Southern Research developed Client Lab^TM. With Client Lab^TM, our research partners are provided password-protected, proprietary access to reports and information updates on their projects. Client Lab^TM is a custom-built application developed to meet FDA CFR 21 Part 11 security requirements. It utilizes 128-bit Secure Socket Layers (SSL) data encryption to prevent unauthorized access to the system and your data. For more information about Client Lab^TM contact your Business Development Manager or email us at busdev@SouthernResearch.org.

Immunotoxicology
Accreditations and Licensures
Affiliations