PRACS Institute, Ltd.

About PRACS Institute

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Frequently Asked Questions for Sponsors

-What is your organizational structure?
-How are projects managed?
-Has the FDA audited PRACS?

What is your organizational structure?
The organizational structure of PRACS Institute, Ltd. is simple with the President and six departments: Clinical Research, Bioanalytical Laboratory, Quality Assurance, Business Development, Corporate Services and Human Resources. This follows our management philosophy that teams larger than 6-8 persons are less effective than efficient small teams.

Clinical Research is the largest department and incorporates all related services. Clinical Research has oversight on all protocol development, consent develop, case report forms, subject recruiting and screening, study enrollment, study management, clinical data collection and entry, clinical laboratory services, medical services, statistics and final report management.

Bioanalytical Laboratory services encompass all activities related to the development, validation or cross validation of all bioanalytical methods. The staff is responsible for processing and analyzing all bioanalytical samples submitted and preparing the final bioanalytical report.

Quality Assurance provides assurance the entire organization is working within the confines of our standard operating procedures, the appropriate regulatory authority and commonly accepted ethical standards of professional research, medical, nursing and pharmacy practice. They also monitor the PRACS IRB to assure compliance with their standard operating procedures and regulatory authority.

Business Development is responsible for identifying potential clients and convincing them to contract our services. They also provide project and information follow-up on project queries and issues of general interest to the client and PRACS management.

Corporate Services is responsible for all financial budgeting, invoices, accounts receivable and financial planning issues, facilities management, information technology development and management and overall corporate strategy.

Human Resources is responsible for recruiting staff, assisting in hiring staff and expertise to augment our corporate goals, tracking our varied training programs, planning internal and external training programs, organizing internal and external expert speakers and assisting staff with personal as well as corporate employee issues. Our Human Resources serves as an advisor for our management team personnel issues as well as a representative for employee rights and benefits.

The President is responsible for assuring the PRACS Institute, Ltd. vision and mission are pursued vigorously by challenging or augmenting any financial, facility or expertise constraints of the corporation.

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How are projects managed?
We utilize the team concept for project management. To explain, each team has a team leader and 4-6 team members. As team members proceed through their training program, they eventually achieve ‘project manager’ status. Therefore, when a project is assigned to a team, responsibility for project management will rotate through the qualified members. All team members participate in study orientation sessions. This allows all team members to assist the ‘project manager’ as a team with screening, case report forms, study oversight, data collection and entry, and data review. With this approach, if the ‘project manager’ is ill the morning of a study, any team member can ‘step into their shoes’ and manage the study. With a group working on data entry and review, the process of completing case report forms becomes efficient and timely. Each team reports to a Clinical Operations Coordinator with no more than two teams per coordinator.

For our bioanalytical teams, the same process is followed with training and assigning staff responsibility as they grow within the team. Each team reports to a Senior Scientist with no more than two teams per senior scientist.

This same team concept is practiced in all other departments and for all other corporate activities.

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Has the FDA audited PRACS?
PRACS averages at least one audit annually for new release drug products. In the past several years, there have been no FDA 483’s for clinical research and two citations for our bioanalytical services. The minor bioanalytical citations were related to documentation issues, which were either historically changed prior to the audit, or in response to the audit. Our citations are available to sponsors upon request.

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When was PRACS' last FDA audit?
July 2003

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For further information about PRACS Institute, Ltd., please do not hesitate to inquire. Please email our Business Development staff at pracsbd@pracs.com. If you prefer, our mailing address is PO Box 9358, Fargo, ND 58106-9358. Our office headquarters address is 4801 Amber Valley Parkway, Fargo, ND 58104 at telephone number (701) 239-4750.

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