ClinAudits, LLC

 

ClinAudits, LLC

170 Kinnelon Road Suite 17 Kinnelon, NJ  07405, USA


Tel:   973.492.8108

Fax:  973.492.7343

©2010 CLINAUDITS LLC all rights reserved

Building Trust in Clinical Research, GXP Auditing and Consulting Since 1994

For Larger Auditing Projects, ClinAudits Employs a Team of Expert Consultants


Competencies encompass a broad range of disciplines including Oncology, Infectious Diseases, Respiratory Diseases, Central Nervous System (CNS), Virology, Cardiovascular, Ophthalmology, and Dermatology in Phases I through IV of clinical research.

We have conducted audits in Europe (East and West), Australia, New Zealand, Russia, China, Asia, Canada, Mexico, South America (Chile, Argentina, and Brazil), India, South Africa, and the U.S.                                      

For more extensive audit projects, ClinAudits utilizes a team approach. Our more than thirty-five auditors are regionally based throughout the U.S. and Canada. For each project, our team employs strict internal quality control measures and follows internal SOPs to ensure that our work meets clients’ individual high standards.


                       Good Clinical Practices (GCP)- Auditing Services


Domestic and International Clinical Research Trial Audits - established expertise in Good Clinical Practices (GCP) auditing to comply with FDA/EMEA regulations, International Congress on Harmonization (ICH) Guidelines, specific company  SOPs/guidelines and local governmental regulations/guidelines.


Contract Research Organization Audits - expertise in auditing CROs for sponsor's pre-qualification consideration and post-capability CRO study management/ CRO managed studies.


Central/Specialty Laboratory Audits - tracking clinical trial laboratory specimens through the laboratory environment to check for compliance to GCP.


Clinical Trial Supply/Drug Depot Audits - auditing all aspects of clinical trial supplies in accordance with FDA/EMEA, GMP, GCP and ICH regulations/ guidelines.


Institutional Review Board Audits/Ethical Committee - perform audits of IRB’s (commercial, academic, private and hospital) and EC’s in accordance with FDA/ OPHR guidelines/regulations and other international, local regulations/guidelines.


Audits of Final Study Reports/NDA submissions/Safety Reports/IND updates- audits of database in comparison to reports/ submissions to FDA or other governmental authorities


Adverse Event Reporting System/Pharmacovigilance Audits - process audit of AERS, SAES, IND Safety report procedures within a country or between countries/ subsidiaries.


Computer Systems Validation Audits- process audit of software and hardware for GCP, GMP or GLP settings to guarantee security and consistency of data.


System/Process Audits, e.g., Mock-FDA audits, electronic submission audits, clinical operations and monitoring, data entry and data management, biostatistical, and medical writing departments.


Training of Quality Assurance and Clinical Research Personnel- customized training to your SOPs. A sampling of our training services includes:

Review of the History and Process of Clinical Research

Review of Important Clinical Research Terminology

Review of the Code of Federal Regulations and FDA Information Sheets

Review of the International Conference on Harmonization (ICH) Guidelines and Essential Documents Needed for Clinical Research

Clinical Trial Designs

Responsibilities of the Investigator

Responsibilities of the Research Coordinator

Responsibilities of the Sponsor

IND Studies, FDA/NIH Funded Studies

Monitoring Requirements and Sponsor Visits

Informed Consent Process and the Informed Consent Document

Recruitment and Advertisement for Patients

Financial Disclosure

Investigator Misconduct

Test Article Accountability

Adverse Events, Serious Adverse Events and IND Safety Reports

Protocol Issues

Medical Device Studies

Data Collection, Source Documentation and CRF Design and Completion

Preparation for FDA Inspections

Current Trends and Findings in Clinical Research Trials- An Auditor's Perspective


ClinAudits is proud to have

joined the Biomedical Quality

Standards Working Group

[click for press release]