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!
Therapeutic Areas of Interest
Optimum Clinical Research, Inc. actively participates in clinical trials with the following indications:
- Allergy
- Cardiovascular
- Angina
- Cardiovascular Disease
- Hypertension
- Dermatology
- Acne
- Endocrinology / Metabolism
- Diabetes Mellitus Type II
- Lipid Disorder
- Obesity
- Thyroid Disorder
- Gastrointestinal
- GERD
- IBS
- Musculoskeletal
- Low Back Pain
- Osteoarthritis
- Osteoporosis
- Neurology
- Fibromyalgia
- Migraine
- Pain
- Parkinson’s
- Sleep Disorder
- Pulmonary
- Asthma
- Bronchitis
- COPD
- Pneumonia
- Psychiatry
- Anxiety
- Depression
- Rheumatology
- Arthritis
- Urology
- Erectile Dysfunction
- Prostatitis
- UTI
- OBGYN
- Menopause
- Other
- Influenza
- Pharyngitis
- Sinusitis
Sponsors and CROs
OCR has earned the trust of the following major pharmaceutical companies and CROs:
- Altana
- Astra-Zeneca
- BioCryst
- Boehringer Ingelheim
- Bristol-Myers Squibb
- Daiichi Sankyo
- Depomed
- DOV
- Forest Research Institute
- GlaxoSmithKline
- Novartis Research
- Ortho-McNeil
- Osiris
- Pfizer Inc.
- Purdue Pharma
- Roche
- Sanofi-Aventis
- Syrrx
- Takeda Global Research & Development
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
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
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
