Information for Sponsors/CRO's

OC Research Clinical Trials
 
QUALITY DATA
 
OCR is committed to working closely with sponsors in providing the most accurate and reliable results!
  • 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.
 
THERAPEUTIC AREAS OF INTEREST
 
Optimum Clinical Research, Inc. actively participates in clinical trials with the following indications:
  • Cardiology: Angina, Cardiovascular Disease, High Blood Pressure/Hypertension

  • Dermatology: Acne 

  • Endocrinology: Diabetes Mellitus Type 1 & Type 2, Lipid Disorder, Obesity, Thyroid Disorder

  • Immunology: Hepatitis, Meningitis, Respiratory Syncytial Virus (RSV), Human Immunodeficiency Virus (HIV)

  • Gastroenterology: Gastroesophageal Reflux Disease (GERD), Irritable Bowel Syndrome (IBS)

  • Gynocology: Menopause

  • Musculoskeletal System: Low back pain, Osteoarthritis, Rheumatoid Arthritis,   Osteoporos

  • Neurology: Diabetic Neuropathy, Firbromyalgia, Migraine, general pain, Parkinson's Disease, Sleep Disorders

  • Pulmonology: Asthma, Bronchitis, Pneumonia, Lung Function, Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Hypertension, Insomnia

  • Psychiatry: Anxiety, Depression

  • Rheumatology: Arthritis

  • Urology: Erectile Dysfunction, Prostatitis, Urinary Tract Infection (UTI)

  • Other: Pharyngitis, Sinusitis, Stem Cell Therapy, Influenza 

 

RECRUITMENT DEPARTMENT

OCR has a dedicated Recruitment department with a full-time phone screening Recruitment Coordinator and a Marketing Director. Our dedicated team creates and enacts a unique Recruitment Plan for each trial in which we participate to ensure that we meet and exceed our enrollment goals. We initiate patient recruitment by combing our 6,500 patient database and contacting potential patients by phone to pre-screen them for study eligibility and subsequently schedule study screening. This is followed by targeted advertisement efforts to reach the necessary patient demographic. Additionally, relationships with local physicians allows for patient referrals.

Note that OCR is a preferred partner with Quintiles due to our enrollment metrics – we ALWAYS meet and exceed enrollment expectations and adhere to the protocol – No protocol deviations!

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

  • Additional staff is available for patient recruitment
  • OCR has worked with a centralized subject recruitment campaign
  • OCR is willing to accept referrals from a recruitment campaign if used

 

SPONSORS & CROs

Optimum Clinical Research  has earned the trust of the following major pharmaceutical companies and CROs:
  • Abbott
  • Advanced Biologics
  • Allergan
  • Altana
  • Astra Zeneca
  • Bristol-Myers Squibb
  • Boehringer Ingelheim
  • Boston Scientific
  • Concepts in Pharmaceutical Research
  • Covance
  • Daiichi Sankyo
  • DOV Pharmaceutical
  • Forest Research Institute
  • GlaxoSmithKline
  • ICON
  • I3
  • INC
  • Inventiv Health
  • Janssen (formerly Johnson & Johnson)
  • Kendle
  • Medpace
  • Merck
  • Mylan
  • Novartis Pharmaceuticals
  • Novo Nordisk
  • Ortho-McNeil Pharmaceuticals
  • Osiris
  • Paragon
  • Pearl
  • Pfizer
  • PPD
  • Sanofi
  • Syrrx
  • Quintiles
  • Takeda Global Research & Development
  • Theravance
  • TKL
  • Toyama
  • Wockhardt
 
 
STUDY MONITORING & DOCUMENTATION
 
  • 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
Optimum Clinical Research  utilizes Central IRB and is not required to use a local IRB