By increasing the amount of accurate and reliable data Sponsors have about clinical facilities, the ClinPharm Network, Inc. helps to match quality providers with the right projects to shorten the time and reduce the costs involved in the launch of new studies.
At the foundation of the ClinPharm Network, Inc. process is a commitment to promoting and advancing Good Clinical Practices (GCP) through our unique evaluation and auditing service. At ClinPharm Network, Inc., we have invested in people and processes to deliver comprehensive resources that help to establish, implement and maintain the highest quality standards in the industry.
Our team of industry experts provides complete evaluation and auditing services for clinical trial facilities. In addition to the site audits and assessments, ClinPharm Network, Inc., also creates and delivers customized on-site seminars and training for facilities staff on good clinical practices.
“Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects.” Source: FDA Running Clinical Trials
- U.S. Food & Drug Administration
- Clinical Trials.Gov (Service of the U.S. Institutes of Health)
- Association of Clinical Pharmacology Units(ACPU)
- CPN Glossary
CPN Audits and Assessments
The ClinPharm Network, Inc. is committed to building and promoting best practices for clinical research facilities and Sponsors engaged in the drug development process. In addition to across-the-board audits and assessments of clinical trial sites, ClinPharm Network, Inc. also provides on-site seminars and training on good clinical practices, FDA audits, and quality management. Our comprehensive operational audit includes a thorough review and assessment of the following functional areas & operational processes:
- Organizational Structure/Management
- Facility Location/Access
- Screening and Recruitment
- Participant/Patient Monitoring and Oversight
- Informed Consent Process
- Biological Sample Processing and Handling
- Pharmacy Operations/Drug Accountability
- Emergency Preparedness
- Clinical Equipment Utilization and Maintenance
- Business Development process
- Staff Training and Training Documentation
- Standard Operating Procedures (SOPs) Overview
- Data Collection/Quality Control
- Quality Assurance Process/Program