United States

Pierrel Research USA (PRUSA) maintains its North American headquarters in Wayne, PA (in the greater Philadelphia area). We offer study sponsors the highest quality services to meet all budgetary and program timeline requirements. Throughout the entire life of each program, we will work together with the study sponsor to assure complete satisfaction.

Potentials

PRUSA carries out national and international clinical trials (Phase I-IV) based on GCP and our SOPs (or the sponsor’s, if desired). We offer complete programs or partial?/?stand-alone services such as those specified below. We conduct clinical trials in many indications; we have extensive experience in early phase studies (Phases I-II) and in a wide range of therapeutic areas including vaccines, biotechnology (e.g., gene therapy and stem cell therapy), oncology, cardiology, CNS, and metabolic diseases. For international trials, a global Program Director will oversee local country Project Managers who are native-speaking and familiar with medical practice patterns in each participating region.

Advantages

PRUSA delivers proven experience and professionalism. We offer clients a flat study management hierarchy and quick decision making processes. We always strive for team work both internally within our own study teams and externally with the sponsor’s extended team. We make extensive use of innovative, validated clinical trial technologies as well as established general practitioner and specialist investigator networks. Overall, our driving force is a passion for quality and results.

Feature

PRUSA enables access to Pierrel’s highly effective and experienced organization which has a physical presence in 20 countries throughout Eastern and Western Europe. As one of the results of this, a sponsoring company can utilize Pierrel’s ever expanding national and global network of highly experienced investigators to support study-specific feasibility assessments and study site recruitment.
We feel that early identification and enrollment of productive study sites is the most critical step in assuring each study achieves rapid patient recruitment and retention. This, in turn, guarantees delivery of study milestones on time with the highest quality data.

Our Services

Coverage of Clinical Trials (phase I – IV)

• Regulatory Consulting and Scientific Planning
• Study Start-Up Activities
• Essential Document Management
• Project Management
• Clinical Trials Management
• Monitoring
• Safety Surveillance?/?Pharmacovigilance
• Data Management
• Medical Writing (e.g., protocol, final report)
• Quality Assurance