SAN DIEGO--(BUSINESS WIRE)--BTS Research, a Contract Research Organization (CRO) that specializes in GLP and Non-GLP preclinical research, fulfilling an FDA requirement for approval to conduct Clinical Trials announced today that they have been recommended for Full Accreditation at their new headquarters following reviewers' first physical evaluation of the new vivarium.
After a thorough evaluation, AAALAC representatives communicated to BTS that they will be making the recommendation for a Full Accreditation to the AAALAC Accreditation Committee. The recommendation came following AAALAC’s scheduled multi-day inspection certification of the new facility. BTS has had a long and outstanding history with AAALAC and this new certification inspection ensures BTS the continued important and well-recognized alignment with AAALAC regulations.
BTS moved to its new facility in late 2015. The new vivarium required BTS to “staff up”, and to bring the training level of many of the local employees (new or experienced) in San Diego to new standards and learn large animal regulations and handling, which created ungrounded inquisition to their execution of the research practices. As a result, BTS had numerous inspections and correspondences from USDA, OSHA, DEA and AAALAC, all to show that the new facility condition and the training program in place met all regulations.
“This is fantastic news,” said Mr. Abunadi, CEO & President of BTS Research. “We are very proud of our new headquarters. It was a long way coming. To receive the Full Accreditation recommendation without even minor issues to address is a great step to build on the wonderful history and reputation BTS has been having for 16 years now. We have been working with the local workforce diligently to bring the awareness and training level to meet the research demand. Since CRO is a very different line of business we ended up having to relocate many wonderful skilled new staff members from other states where large animal CRO’s like Covance, Charles River, MPI and Envigo reside and have a larger talent pool,” Mr. Abunadi added.
“It has been a good opportunity for BTS to spread the awareness regarding what we do. When the USDA did their inspections, their findings were in line with the bringing of our small CRO to a mid-size organization and that is a normal evolutionary step. We have fully acknowledged and addressed these issues. We work with all our auditors and inspectors for any opportunities to improve and perfect our work. Animal regulations and animal comfort are not only a personal goal and requirement from each and every employee, but also our lifeline and creditability. We are committed to our sponsors and our research -- our work quality has never been an issue. We have taken on the development of some very complicated large animal research models and this is a great asset to bring to the West Coast. With the help of our seasoned staff, we are now and will continue to be even more vigilant than ever in how Study execution and one-on-one training is handled,” Mr. Abunadi stated.
About BTS Research
BTS is a San Diego-based Contract Research Organization that delivers GLP and Non-GLP biological services to large and small clients in pharmaceutical/biopharmaceutical, biotech, academic research and medical device organizations in the areas of Inflammation, Metabolic Disease, Cancer, Stem Cell and Medical Devices since 2001. BTS Research is a recognized leader in providing global preclinical solutions in all regulated species from early discovery to IND enabling studies.