FAQs for Sponsors
1. What are the advantages of working with the PIER consortium to conduct clinical trials?
PIER provides a single point of contact giving you access to more than 40 sites and 2.8M patients in a wide and diverse geographic area. Instead of multiple negotiations, contracts, budgets and providers to manage, there is one central PIER office to coordinate all activity. Streamlined communications reduce time and complexity. PIER’s centralized approach improves efficiency by reducing the burden on Sites, which allows them to focus on recruitment and core study activities. The PIER approach focuses on consistent quality across Sites with uniform training and quality assurance. Our network is composed of experienced study teams and a wide breadth of disease expertise.
2. What is the geographic scope of the PIER network?
PIER Sites are currently located throughout New Jersey and Pennsylvania.
3. What is the difference between a PIER Member and a PIER Site?
“Member” refers to an institution or health system that is an official PIER partner. Each member may have multiple “Sites” with research activity advanced by Principal Investigators and study teams. The Site is the actual location conducting research within the member institution.
4. Who owns PIER?
PIER is a nonprofit limited liability company (LLC) formed to promote health sciences education and research. The Consortium formed exclusively for charitable, scientific and educational purposes. All consortium members that contributed to the formation of PIER now share in the governance and oversight of the organization.
5. How is PIER managed?
The PIER Consortium’s Board of Managers is responsible for oversight of the consortium’s business. The board is comprised of members who participate in shared decision-making and collaborate to develop policies and procedures.
6. What role do the Sites play in the PIER organization?
At each member institution, the Site’s participation is key to the success of PIER research. The Sites interact closely with the PIER Central Office (PCO) staff from study start-up through study closeout, providing documentation/data to the PCO as needed and conducting studies to the highest professional and quality standards. Once the study is approved and enrollment begins, Sites will conduct the research study and all associated clinical activities according to the Site’s internal standard operating procedures.
7. What services does PIER provide to Sites?
PIER performs all contracting, budgeting, and regulatory activities through a single entity. PIER allows sponsors to engage all the members without having to contract and negotiate with each one individually. PIER can negotiate legal agreements on behalf of the members. PIER also works with central IRBs to speed the entire study approval process. PIER submits the study for IRB approval and manages the IRB submission. Post-award financial management (invoicing, accounts receivable and accounts payable) are provided for the Sites by PIER, according to the approved budget.
8. How are Principal-Investigators (PIs) recommended for a study?
Each Member’s Physician-Investigator Advisory Committee representative or Research Office submits recommendations to the PIER Central Office. Each PI must have appropriate clinical and research experience relative to the proposed study. They must also have adequate resources, such as an experienced Clinical Research Coordinator.
9. Who determines if a Site is eligible to participate in a PIER study?
Selection is based on Sponsor preferences and factors such as:
a. Previous performance in working on similar studies
b. Qualifications established by the sponsor relevant to the specific study
c. Available resources to adequately conduct research study
d. Evaluation of past research performance and metrics.
11. Who makes the final decision on which Sites participate in a PIER study?
Site participation in a PIER study is voluntary. The decision by the PIER Consortium to pursue a study with a sponsor is a collaborative decision with input from the PIER Chief Operating Officer, the Physician-Investigator Advisory Committee, the member Central Research Office, potential principal investigators and study teams. The final decision to select Sites is made by the Sponsor.
PIER Central Office (PCO) Contacts: