Sponsors/CROs

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Quality Data

• The Principal Investigator (PI) oversees study activity on a daily basis.
• OCR maintains positive ongoing relationships with sponsors due to a track record of quality data.
• OCR has a Quality Assurance Manager on staff to ensure adherence to Federal guidelines and protocol specifics.
• OCR personnel receive comprehensive training for every protocol.
• In addition to protocol training, all personnel are members of the Association of Clinical Research Professionals (ACRP) and attend annual training conferences within the research training community.
• OCR is committed to working closely with sponsors in providing the most accurate and reliable results!

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Therapeutic Areas of Interest

Optimum Clinical Research, Inc. actively participates in clinical trials with the following indications:

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Sponsors and CROs

OCR has earned the trust of the following major pharmaceutical companies and CROs:

Recruitment Strategy

OCR is dedicated to meeting Recruitment goals!

To maximize recruitment efforts, OCR may utilize the assistance of Clinical Site Services, a company designed to assist research sites in advertising by reaching target audiences based on demographic knowledge.

Study Participants will be identified per HIPAA guidelines using:

• Current research patient database
• Referrals from affiliate Alpine Medical Group
• Referrals from other physician practices
• Internet websites
• Advertising in community: newspapers, radio, TV, flyers (dependent on sponsor budget for advertising)

Informed Consent Process is discussed with potential participants by Principal Investigator and Study Coordinator per FDA guidelines.

• Additional staff is available for patient recruitment
• On average, a Clinical Study Coordinator spends 3 to 6 hours a week on patient recruitment
• OCR has worked with a centralized subject recruitment campaign
• OCR is willing to accept referrals from a recruitment campaign if used

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Study Documentation and Monitoring

• OCR Coordinators are responsible for maintaining research study records
• Site has experience with Electronic Data Capture Systems (EDC)
• Records and CRF’s are kept on site in the OCR office
• OCR study monitor will have access to the medical charts for direct review
• OCR has access to hospital medical records
• OCR has experience creating its own non-CRF source documents

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Regulatory History

The FDA has NOT audited the Principal Investigator

• The FDA has NEVER sanctioned the OCR Principal Investigator or otherwise placed restrictions on his ability to conduct research
• The State Medical Board has NEVER sanctioned the OCR Principal Investigator, including placing conditions on or otherwise limiting the Principal Investigator license
• NO IRB has ever disapproved, suspended, or terminated any study undertaken at OCR or by the Principal Investigator
• OCR was sponsor audited due to high enrollment for 5 pivotal studies. All Audits were favorable.
• OCR has never been terminated early for a study

Institutional Review Board:

• OCR utilizes Central IRB and is not required to use a local IRB

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