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Quality and Compliance Consulting, Inc.

Description: 

Quality and Compliance Consulting, Inc. (QC2) provides worldwide audit and consulting services to the pharmaceutical, medical device, and biotechnology industries.  Founded in 1996, QC2 has conducted over 2,700 audits in 48 countries for more than 240 clients, ranging from small start-up to multinational pharmaceutical, medical device, and biotechnology companies.  QC2 clients have also included contract research organizations, bioanalytical and toxicology laboratories, institutional review boards, university and private medical research centers, and investigators.

Our expert staff will help you find practical solutions for regulatory compliance issues, develop and maintain quality systems, assess study conduct and compliance, and ensure the validity and accuracy of your study data.  Your company will benefit not only from our experience and expertise but also from the personal attention we give to each project and our dedication to providing high quality, cost-effect services.

Our services include:

GCP Audits

Investigator Sites
Phase I Facilities and Studies
Institutional Review Boards
Essential Documents/Trial Master Files (TMF)
Electronic Trial Master Files (eTMF)
Data Listings
Clinical Trial Reports

GLP Audits
Toxicology Facilities and Studies
Formulation Analysis and Bioanalysis
Pathology Evaluations including Contracted Reading Vendors

Bioanalytical Laboratory Audits (GCP and GLP)
Large and Small Molecules
Biomarkers

Clinical Pathology Laboratory Audits
Safety Panels
Flow Cytometry
Molecular Diagnostics
Cell-Based Assays
Specialty Diagnostics

Sponsor, CRO, and Vendor Audits
Clinical Operations
Data Management and Biostatistics
IVRS/IWRS
Central Reading Centers
Electronic Data Capture (EDC)/Remote Data Capture (RDC)
Site Management Organizations
Safety Reporting

Computerized System Validation Audits
Data Management Systems and EDC
Safety Databases
IVRS/IWRS/IXRS
Electronic Patient Reported Outcomes (ePRO) Tools
Laboratory Information Management Systems (LIMS)
Other Applications

cGMP Audits
QC Laboratories
Investigational Product Packaging and Labeling Facilities
Depots/Distribution

Standard Operating Procedures
Gap Analysis
Review and Revision
Preparation

Training
GCP
GLP
21 CFR Part 11
SOP
QA

Consulting
Audit Plan Development
Audit Follow-Up and Review of Corrective Actions
Preparation for FDA Inspections and Mock FDA Inspections
Clinical Outcomes Assessment (COA) Consulting, including Patient Reported Outcomes (PROs), Clinician Reported Outcomes (ClinRO), and Observer Reported Outcomes (ObsROs)

Services: 

Bioanalytical Data Audits/Laboratory & Validation Evaluation, Computer System Validation, Consulting, Contract Auditing, Data Validation, GCP Compliance, GLP Compliance, Quality Assurance/Control, Standard Operating Procedures, Training

Contact Information: 

Quality and Compliance Consulting, Inc.
409 West Olympic Blvd., Suite 708
Los Angeles, CA, 90015, USA
Phone : 4242083340
Fax : 8315155072
Internet : www.qc2.com
Email : qc2@qc2.com
Contact Person : Jason Bertram