Date/Time: 7/5/2008 8:46:11 AM EST.

Quality Program

Through the PIVOTAL® quality system, Pivotal achieves world-class quality and protocol fidelity. The results are shorter monitoring visits, cleaner data, and more CRF pages pulled at each visit. Following are the key components of the program:

Selection of the Project:

It starts with a systematic protocol review with our Clinical Operation Managers, Marketing Director, COO, Budget/Contract Manager, and Clinical Investigators. We will not commit to a study unless we feel certain we can successfully complete the project to your satisfaction.

Project Management Teams:

Each project is staffed by a team headed by an experienced coordinator. The teams are cross-trained on the studies they conduct. Members of the team participate in the study initiation meeting to address the marketing, staffing and logistical issues pertaining to the study.

Physician on Site:

A physician is available at all times for patient visits and protocol, consent, medication, adverse event, and sponsor issues.

Source Documents:

Source documents are customized according to the requirements of the protocol and the Case Report Forms. Each visit is organized to capture all required data. Progress notes are recorded in the chart for each visit. Study charts are standardized within each study and between studies.

Monitor Visit Meetings:

During each monitor visit, the responsible coordinator and principal investigator meet with the monitor to review the visit.

Staff Training:

All clinical staff is BLS and NIH certified to ensure participant safety. They also receive regular Good Clinical Practice and certification training.

Regulatory Expertise:

A full-time, dedicated staff performs all regulatory functions at the Peoria/Sun City and Mesa sites. They have extensive experience with GCPs and regulatory requirements, resulting in superb compliance. Additionally, they serve as quality consultants to the other Pivotal sites.

Standard Operating Procedures:

Pivotal Research has standardized its key internal processes resulting in high compliance with GCP's and Pivotal's own quality standards.

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