Investigator Support Services (ISS) eliminates the challenges and costs associated with identifying high-quality research sites for phase I-IV clinical trials in every therapeutic area. With more than 15 years of unrivaled experience, we deliver exceptional client service by matching the most appropriate research sites to the complex needs of pharmaceutical sponsors and contract research organizations (CROs).

Locations and Settings

ISS has long-term relationships with over 400 independent, multi-specialty and single specialty research sites in the United States and an elite group of sites throughout Canada, India, and Mexico. Research studies are managed in a variety of medical settings, including private practices, full-time research sites, and community hospitals. Our partner sites are GCP/ICH-trained and fully compliant with clinical trial regulations within their respective national/local governing bodies.

Diversified Capabilities

With over 2500 investigators board certified in all major medical specialties, our sites have the experience, patient populations, and capabilities necessary for phase I-IV drug and device study participation. Averaging 50 studies per site, our Phase I Units are experienced working with healthy normals and disease patients in several specialty areas. Late phase investigators average nearly 100 studies per site within and beyond their areas of board certification. To meet inpatient and outpatient recruitment goals, our sites offer large patient databases, community outreach and ad placement experience, and physician relationships for patient referrals.

Through extensive site screening, ISS provides access to a large pool of investigators who meet our quality and performance benchmarks. We utilize a three-step process for evaluating initial site quality, study-specific pre-qualification, and continual quality assessment from all perspectives. International sites adhere to the same benchmarks and screening process as US sites in our network.

Preliminary Screening

Our initial screening begins with a comprehensive site/staff background check that includes CV reviews, medical license verification, and state medical board and FDA audit checks with thorough review of all 483s. Clinical research abilities are rated based on several criteria, such as:

• Phase I-IV capabilities and experience in drug and device trials.
• Fully trained, certified coordinators and investigators averaging over a decade of research experience; supported by administrative, recruitment and regulatory staff.
• Access to substantial disease patient, treatment-naïve, healthy normal, and minority populations.
• Established SOPs supporting rapid contract and budget negotiation time.
• On-site technology infrastructure including high-speed Internet, EDC experience, and medical testing equipment.

Study Pre-qualification

For each study, we identify appropriate sites based on protocol requirements and sponsor preferences. Upon collection and review of study-related documents (CDAs, Questionnaires, CVs, etc.), we submit completed documents for the most qualified investigators. Sponsors make the final site selection decision, communicating directly with site personnel for further qualification and contract negotiations.

Ongoing Monitoring

ISS site performance is monitored on an ongoing basis by continually analyzing site-reported data and statistics from our internal tracking systems. Periodically, our staff will check in with the sponsor/CRO for site selection confirmation, enrollment data, and performance feedback. By assessing issues such as patient recruitment and retention, site compliance, and document turnaround times, we can continue to ensure overall site quality.

Business Operations

ISS has established the following operational processes that meet the needs of sponsors, CROs and research sites:

• Site Selection: Sponsors/CROs review all study-related documents, choose which sites to further qualify, and make the final site selection decision.
• Negotiation Process: Sponsors/CROs negotiate contracts and budgets directly with site personnel without ISS involvement.
• Business Development: Research sites pay all related fees to ISS in exchange for business development services.
• Payment Structure: Sponsors make investigator payments directly to the research sites for all clinical trial services.

Direct Communications

Once we have pre-qualified and referred sites for a particular protocol, ISS puts sponsors/CROs in direct contact with research site personnel. We continue to facilitate the relationship between the investigative site and the sponsor/CRO while remaining in contact with all parties through the close of the study. This commitment to relationship building makes ISS a trusted resource and partner throughout the business process.

Contact Information

Investigator Support Services, Inc.
Bozena Szorc, Managing Director
1320 N. Milwaukee
Chicago, IL 60622 USA
Phone: 773-278-1567
Fax: 773-278-2935
E-mail:

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