In Phase II-IV

PharmaNet offers all the clinical development services traditionally associated with conducting Phase II-IV programs. A key differentiating factor of PharmaNet is that in every program we conduct, PharmaNet provides an unrivaled combination of experienced project-management teams, senior management oversight, and an exclusive approach to building relationships with sponsors.

Quality Control/Assurance

The PharmaNet Quality Control/Assurance team provides expertise to ensure that client programs are conducted with the highest-quality project management and in strict compliance with industry guidelines.

 

Available services include:

Data-integrity review
Generation and review of standard operating procedures (SOP)
Guidance on Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP)
Joint implementation of GCP/ICH guidelines with sponsors and investigators to ensure the integrity of clinical data
Capability assessment and recommendations for process improvements
Conduct of GCP/GMP audits
Preparation of compliance reports
QC/QA consulting
Preparation for FDA and European Regulatory Agency inspection

 

 


Martin F. Valania

Vice President, Corporate QA and Compliance

Mr. Valania has more than 15 years experience and is a Certified Quality Manager and Certified Quality Auditor through the American Society for Quality. Before joining PharmaNet, he was the director of quality systems at a major CRO and the associate director of manufacturing processes at DuPont.

PharmaNet Development Group, Inc.504 Carnegie Center, Princeton, NJ 08540Tel 609 951 6800Fax 609 514 0390