About Us

Regulatory Compliance & Quality Assurance

Sinclair is fully GLP-compliant and our personnel have many years of GLP experience. Sinclair has an independent Quality Assurance Unit that audits the facility, protocols, in-life critical phases, raw data, and reports for GLP studies. Sinclair is inspected by the FDA on a regular basis.

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

• Pristima® Version 7.1 or newer
• SEND Savante ™ 7.2 or newer

Sinclair Research Center is proud to offer GLP data sets in SEND (Standard for Exchange of Nonclinical Data) format for submission to the FDA, which supports faster and better quality regulatory review. We use Xybion’s suite of programs, notably Pristima® and SEND Savante™ for quality data acquisition, reporting and dataset creation. Our dedicated study data team works in-house to ensure your data, from collection to submission, is accurately converted to SEND format. Systems are validated and have been assessed for 21 CFR Part 11 compliance. Data capture using the Xybion suite of programs allows Sinclair to provide cost effective and compliant management and oversight of studies.

Sinclair has a Strong Commitment to Animal Welfare

At Sinclair we are all strongly committed to animal welfare and we have a documented quality animal care program, including a ‘Code of Respect’ for all our animals. Our commitment to adhere to and exceed the highest ethical and scientific standards is demonstrated by our outstanding veterinary care program, our full compliance with the Animal Welfare Act, and our accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International).

High Quality Animal Care

Our animal care programs at Sinclair Research are maintained at the highest level at all times. This is confirmed by the excellent ratings we receive from our many regulatory inspections. Everyone at Sinclair is strongly committed to animal welfare; we have a documented quality animal care program, including a ‘Code of Respect’ (listed below) for all our animals. Our commitment to adhere to and exceed the highest ethical and scientific standards is demonstrated by our outstanding veterinary care program, our full compliance with the Animal Welfare Act, and our accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International). Clinical pathology and veterinary services are offered on-site to support our high standard of animal care.
 

Animal Code of Respect

As a leading provider of preclinical drug and device testing services, we accept both the legal and moral obligation to assure that animals in our care are treated in accordance with all applicable regulations and with high standards of compassion and respect. Sinclair maintains full AAALAC accreditation and meets or exceeds USDA and Public Health Service (PHS) standards. In addition to adhering to law and ethics, this obligation is scientifically important, as failure to meet these regulations and standards can undermine the validity of scientific research. Toward that end, all of us at Sinclair are committed to following these principles:

• We will treat animals in our care with the utmost respect. We honor the contribution that these animals make to lifesaving advances and will in turn treat them with the respect that they deserve.
• We will strictly follow all applicable regulations and standards for animal treatment.
• We will not conduct research on animals when validated alternatives are available, or when the potential benefit of the research is unclear. When animal research is scientifically valid, we will employ the “three R’s” principals to animal use: replacement, reduction, and refinement.
• We will work, in a manner consistent with the study protocol and good science, to reduce discomfort or stress to animals in our care, and provide a nurturing, comfortable, and enriched animal environment.
• We will train all Sinclair employees who handle animals on proper techniques and will apply appropriate controls to ensure that all procedures as well as this Code of Respect are followed. We will encourage employees to report any misconduct or failure to adhere to this Code of Respect.
• If we learn that we or any of our employees have failed to follow this Code of Respect, we will take appropriate remedial and disciplinary action.

Certifications

Sinclair Research maintains certifications, licensure and successful audits and inspections from many agencies. These include:  

• AAALAC accredited
• USDA
• DEA
• FDA
• EPA
• OSHA
• State of Missouri agencies

Research Staff

Sinclair Research has a friendly, experienced, and motivated multidisciplinary scientific, veterinary, and research staff who provide you with quality study execution, excellent communication, and timely reporting. Experienced study directors and principal investigators, aided by support staff, maintain full control over each individual study through vertical management. Complementing the research personnel are competent veterinary staff members who participate in all studies by conducting procedures, collecting samples, and maintaining animal health. Qualified laboratory animal personnel skilled in husbandry provide care for the animals. A full training program is in place and all personnel have current training records.

Sinclair boasts board-certified veterinarians, medical doctors, and PhD scientists ensuring the in-house skill and expertise are at the highest level possible. Sinclair also relies on a network of board-certified consulting veterinarians for more specialized disciplines: a cardiologist offers on-site echocardiography consulting, an ophthalmologist examines the eyes of animals on regulatory GLP studies, and pathologists conduct the necropsies. Additionally, we have experienced clinical pathology staff and GLP clinical pathology services on-site. Contract histopathology services are also utilized as required.

Client Testimonials

Client Comment
All of the personnel I have worked with at Sinclair, through several separate studies have been very professional, responsive, accommodating and personable. The quality of the products I have received has been outstanding.
– MEDICAL DEVICE 

Client Comment
Thank you again to your fantastic team, led by Tim. This was a huge study and we could not be happier with the functional readouts we have achieved thus far!
– BIOTECH COMPANY

Device Client
I just wanted to let you know we heard late last night that we have received approval from the FDA! This is a huge milestone for us and would not of been possible without your dedication help and expert knowledge.  I have no doubt that only for you all this would not of happened!! Thanks and I look forward to working with you all in the future
– MAJOR MEDICAL DEVICE COMPANY

Device Client
I would personally like to thank you and the entire team at Sinclair who worked on these studies for us. I am very impressed with how the studies were handled and how you provided updates on how things were progressing. I am also looking forward to our continued collaboration.
– MEDICAL DEVICE COMPANY

Device Client
Thank you. As I have mentioned before I am very impressed with every aspect of our business with Sinclair – you are always on schedule or ahead of schedule and I find that very refreshing in today’s business climate.
– CEO, MEDICAL DEVICE COMPANY

Device Client
Thank you very much for this news and the update. I really appreciate you being proactive- it is a pleasure doing business with you and Sinclair.
– CEO, MEDICAL DEVICE COMPANY

Client Comments
I wanted to thank you and the Sinclair team for all you have done for me and my team this year.  You are amazing at what you do.  The way it’s done is also very much appreciated.  Please pass my sincere appreciation to the rest of your team.  Looking forward to working together through 2015’s greatest challenges!
– DIRECTOR OF RESEARCH AND DEVELOPMENT

Pharmacology Client
Please feel free to mention my name in regard to working with Sinclair.  You can add that I think your facility, staff and scientific capabilities are top notch – great communication, attention to detail, and just overall a pleasure to work with.
– VP, PHARMACOLOGY

Wound Healing
Very much like our French restaurants, I would like to grade your facility with a *** 3 stars. I have been very impressed by the rigorous maintenance of the facility and the professionalism of all the employees I met. But this is not enough to do a good job. The real proof your employees are doing a good job is in the behavior of the animals you take care of.  I have seen ‘happy’ dogs and cats. They come and play with you as you enter the building, they are not retracting in a corner of the cage. But this would not be enough to attain success. I think the people working with you like their job and environment. I was guided around the facility by two charming ladies from your Business Development Team. Obviously, they were proud to show me around and were very informative in a very short time. Let me send a special thank you to your Research Team who did a great job with the three pigs. Very clean, very meticulous, very professional, but also friendly. Your overview of the Sinclair business and history was very important to understand the business philosophy. In short, we will return. Thank you for all the excellent work you have done for us! I’m sure we will have the opportunity to work together again. We all think very highly of you and your team.
– SATISFIED CLIENT, DIRECTOR TOXICOLOGY RESEARCH, BIOPHARMACEUTICAL COMPANY

Client Comments
Thank you for all the excellent work you have done for us! I’m sure we will have the opportunity to work together again. We all think very highly of you and your team.  Your staff has been a pleasure to work with and has always produced quality results for us and has went out of their way to help others in our group with strange queries and projects. I too look forward to projects in the future that will give us the opportunity to work together again.
– DIRECTOR TOXICOLOGY, MID-SIZE PHARMA

Client Comments
Sinclair is an amazing company and I am glad for our partnership!
– DIRECTOR R&D

Client Comments
Our GLP studies at Sinclair went very smoothly, with the hard work and dedication of the Study Directors and all the people involved in the study. I got timely updates of all issues, and reports were on time as well. The Senior Director of Business Development is especially helpful accommodating and adapting to our changing needs. I found Sinclair staff to be very responsible and responsive and took our studies at heart. I would work with Sinclair anytime, and I highly recommend them to others.
– RESEARCH DIRECTOR