SPONSOR INFORMATION

• A dedicated and professional team of Clinical Research Staff, including; The Director of Research, Principal Investigator, Sub-Investigators, Regulatory Manager, Study Coordinators, Data Managers, Pharmacy Technicians, RN’s, and CT Technicians

• Central IRB

• Gabrail Cancer Center IBC (Institutional Biosaftey Committee)

• Contracting services to produce effective and timely Clinical Trial Agreements

• Advertising department committed to working with sponsors for public relations

• Consistent internal monitoring and mentoring of our research staff

• Planning for long-term research opportunities

• Rapid Recruitment

• Rapid Start Up, 90% of the time we are the first site to open and enroll

• High Patient Retention Rate

• Accuracy and Timely Data Collection

• Free Wireless High Speed Internet

• Access to phone, fax, and copy machine

• Accessible and Free Parking

• Dedicated Monitoring Room for Sponsor Staff

• Electronic Medical Records with secure, read-only access

• Secure climate controlled storage of research records

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GCC’s Clinical Research has a strong history of partnering with pharmaceutical companies, contract research organizations, and government agencies to perform Investigator Initiated Research, Bioequivalence studies, Special PK studies, Phase I, Phase II, and Phase III studies.

Phase 1 clinical trials are the most sophisticated and complex initial steps in new drug development. This process involves the first step in testing potential anti-cancer drugs after animal experimentation is completed.

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Research centers chosen to conduct Phase I clinical trials in their own designated Phase I unit must demonstrate a plethora of characteristics including utmost accuracy, clinical competency, well-trained dedicated staff, and state-of-the-art facility and equipment necessary to store and reconstitute the experimental agents under

strictly-controlled conditions.

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GCC has vast Phase 1 clinical trial capabilities and experience that includes:

• First-in-Human

• Single Ascending Dose

• Multiple Ascending Dose

• Adaptive/Accelerated Protocols

• Food Effect

• Drug/Drug Interaction

• Age & Gender

• Patient Specific Populations

• Bioavailability/Bioequivalence

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The GCC Phase 1 program is destined to accomplish the following noble goals:

• Area patients have now access to these trials in their backyard saving them the inconvenience of traveling a far away distance. Many cancer patients have a limited time to live. It is only right that we make such critical services available to them where they reside and live. We all owe it to our patients to give them access to state-of-the-art, cutting-edge technological advances at their disposal. They deserve that choice. It is up to us, the physicians, to ensure that patients are aware of what is available to them locally

• Generating new jobs in the area mainly by recruiting fresh graduates from area colleges and universities. We will need additional, qualified workers–our local graduates are a resource

• Bringing additional revenues from the rest of the U.S. and abroad. These revenues can only create additional high paying jobs for our local, qualified, graduates many of whom leave the region after completing their education

• Adding Stark County to the Biotech corridor that currently extends from Cleveland to Akron. We, at GCC, are committed and determined to make Canton part of this crucial biotechnology corridor

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Our center is located in Belden-Village close to the Akron-Canton airport, shopping, hotels and several dining options available for your business needs.

Gabrail Cancer Center is happy to announce the opening of the new phase 1 clinical trials unit. The unit is fully functional and ready to house patients for more in depth clinical trials. The phase 1 unit is already being utilized for a trial requiring patients to remain in it for a week at a time. Boasting 16 rooms, a kitchen, and a large common area with many entertainment options, the state of the art unit is prepared to take on many upcoming trials.

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Gabrail Cancer Center has conducted more than 200 Phase I studies and more than 500 Phase II-IV oncology studies.

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“Our experienced staff provides expert delivery of services to safely and efficiently manage early-phase studies including; first-in-human, proof of concept, maximum tolerated dose studies (MTD), food-effect pharmacokinetics & pharmacodynamics studies, drug-drug interaction (DDI), bioequivalence, biosimilar, bone-marrow harvest, skin biopsies, and specific patient populations,” - Carrie Smith R.N., Chief Operations Officer.

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The current expansion announced is a reaction to the needs expressed by the biotech and pharmaceutical industries requiring additional bed capacity with overnight observation, and frequent blood and body fluid sample collections. There is an increasing demand for such services and Gabrail Cancer Center is well positioned to meet such needs, considering the vast experience the center has had over the last two decades, complimented with a cadre of clinical and support staff. What makes the center unique is that the clinical research coordinators, data management specialists, and other research staff work alongside the rest of the care team every day.

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“Our philosophy is prompt, accurate, accountable and cost-effective services. GCCR has gained national recognition in efficient execution of contracts followed by efficient completion of the projects. Time is of the essence for new drug developers, accelerating the early stages of drug development translates into shorter time for the drug to get to market,” - Nash Gabrail M.D., Medical Director and CEO

Gabrail Cancer Center is fortunate to have 7 colleges and universities within a twenty-mile radius in Stark County and the surrounding areas. This is a great resource for healthy volunteers of all ethnic and racial backgrounds, since this region’s ethnic mix is a mirror image of the ethnic distribution of the United States. We look forward to working with the biotech and pharmaceutical companies even more closely.

• Refrigerated Centrifuge

• Ambient Centrifuge

• Access to Dry Ice

• Dedicated Research Pharmacy/Secure Storage

• -20 Freezer

• -80 Freezer

• Back-up Generator

• Ultrasound

• EKG

• Crash Cart

• Defibrillator

• Water bath

• Vortex

• Holter Monitor

• Manual and Automated BP monitoring

• ICH-GCP trained staff

• IATA certified study coordinators

• CLIA certified on-site laboratory

• Imaging (CT scan) center on-site

• In-office pharmacy dispensing

• Private bedrooms

• 24 hour patient monitoring

• 20 Infusion Chairs

• Dedicated Monitoring Space