CliniQAl ^TM, INC PROFESSIONALS

CliniQAl ^TM, Inc. is a network of seasoned industry professionals with international and US clinical research and clinical laboratory expertise. We provide consulting services to include: quality auditing (GCP, GCLP and GMP), QA infrastructure development, training and clinical laboratory accreditation services. Our efforts are focused on the US and Asia Pacific markets with viable expertise in the Australasian, South American and European markets.

TOBIN C. GUARNACCI,
FOUNDER, PRESIDENT AND PRINCIPAL CONSULTANT

Tobin brings over 20 years of relative experience to the field of regulatory compliance and quality assurance (QA) related to clinical studies of drugs, biologics and medical devices. He is a former Consumer Safety Officer with US FDA and has 15 years of international and domestic QA and quality auditing experience related to GCP, GMP and good clinical laboratory practice (GCLP). Additionally, he has 11 years of management and project management expertise related to GCP and clinical laboratory QA infrastructure development and 7 years experience as a clinical microbiologist.

Tobin spent 10 years in Thailand supporting the QA process as it related to US sponsored HIV and Dengue Hemorrhagic Fever vaccine, and HIV antiretroviral drug trials. Tobin also has extensive experience conducting GCP, GCLP and GMP audits in the Australia, Belgium, Brazil, Germany, Japan, Thailand, United Kingdom and United States.

Tobin’s clinical, laboratory and vendor auditing and QA infrastructure development expertise includes experience in the following therapeutic areas:

• Infectious disease vaccine development (HIV and dengue hemorrhagic fever),
• Antiretroviral drugs,
• Orphan drugs (enzyme replacement therapies),
• Class II and III significant risk medical devices to include: cardiac (vascular and endovascular devices) and  in-vitro diagnostics.

Tobin was responsible for securing the first College of American Pathologist (CAP) international accreditation (with distinction) for three clinical laboratories in South East Asia (Thailand). 

LICENSURES/CERTIFICATIONS 

Certified Biomedical Auditor (CBA)
Biomedical auditing specialty certification with the American Society for Quality, 2002

 CAP/LAP Inspector
Advanced Clinical Inspector for Laboratory Accreditation Training Program – College of American Pathologist/Laboratory Accreditation Program, 1999 and 2007

Certified Quality Auditor (CQA)
Professional certification with the American Society for Quality, 1998

 M(ASCP) Certification
Specialty certification in Microbiology with the American Society of Clinical Pathologists, 1990