Contract Quality Assurance Services for the Biomedical and Pharmaceutical Industry
MediStat Statistics in Medicine - provides confidential data and report auditing, laboratory qualification inspection, training, and consulting services for companies conducting FDA- or EPA-regulated research, including Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) inspections. Projects range from short-term data or report audits and inspections to long-term, complex, multi-auditor assessments. We can provide third party auditors, temporary members of client quality assurance units (QAUs) in audit overflow situations, and entire QAUs for facilities conducting a small amount of regulated research. Our staff includes registered quality assurance professionals (RQAP-GLP) with education, training, and/or laboratory experience in the following scientific disciplines: analytical/bioanalytical chemistry, enzymology, medical technology, microbiology, and toxicology. Contracted Quality Assurance (QA) services, short or long-term, are customized to meet client needs and may be conducted according to MediStat or client standard operating procedures (SOPs).
MediStat conducts prestudy site qualification inspections, data and report audits, and phase (in-life) inspections for all aspects of nonclinical safety studies. Audits are conducted against applicable study protocols, U.S and international regulatory requirements, and standard operating procedures; industry standards are also considered. MediStat has particular expertise in auditing analytical and bioanalytical data, including toxicokinetic and pharmacokinetic data and reports. Audit reports include recommendations for remediation of findings. Our QA professionals also conduct systems-based audits and help clients prepare for FDA inspections.
MediStat performs audits of human clinical trials. Services include reviewing regulatory documents, informed consents, and screening logs, and verifying appropriate documentation of any protocol exceptions, evaluating the storage and handling of investigational drugs, verifying that study procedures are conducted according to the protocol, verifying that study procedures and data are appropriately documented, reviewing the maintenance and standardization of instruments, and reviewing the case report form data against source documents. We verify the data in clinical study reports, including the pharmacokinetic and bioanalytical sections. In addition to site audits, MediStat conducts database audits and assessments of bioanalytical laboratories and bioanalytical method validations. Audit reports include recommendations for remediation of findings and suggestions for improvement when requested.
Veterinary GCP- and GLP-Related Services
MediStat has extensive experience providing QA services to the animal health industry in the conduct of GLP laboratory studies as well as clinical trials in both companion and production animals. MediStat evaluates target animal safety studies and residue studies for compliance with GLPs and has particular expertise in the auditing of bioanalytical data and bioequivalence studies. Services include facility qualifications; data and report audits; phase inspections; protocol, data collection form, and SOP reviews; and training.
MediStat has developed training modules that address GLPs and GCPs. Experienced staff members provide introductory, general, and refresher GLP and GCP training and topic specific training such as the auditing of analytical and bioanalytical data and study director responsibilities. Training sessions are tailored to meet client requirements and may be directed toward the needs of technicians, study directors, QA and regulatory personnel, scientists, monitors, or others. Sessions are interactive and post-training questions are encouraged.