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Protocol Development

Methodological rigor integrated with operational acumen is a key principle at Ocean Blue Medical Research Center and one of our differentiators.

This philosophy is reflected in all aspects of program development, as well as protocol development and extends from first-in-man trials and proof-of-concept paradigms through peri-approval investigations designed to highlight clinical attributes of a new product prior to commercialization or establish a basis for reimbursement decisions.

Contingent upon phase of development and hypotheses to be addressed, the scope of data reviewed includes all aspects of preclinical pharmacology, toxicology and biodisposition/pharmacokinetics that might potentially form the design of an investigation. This data, in turn, could impact patient and subject characteristics designed to enhance signal detection, the dose range to be evaluated and methods of dosage escalation or termination, structural elements of a protocol including adaptive designs and more traditional interim analyses, the selection of both pharmacodynamic as well as clinical based outcome measures and all "rules of engagement" regarding data acquisition and approaches to biostatistical analyses.

Facilities within Ocean Blue Medical Research Center also permit the development of novel assays for either efficacy or safety assessments, full pharmacokinetic analysis capabilities including PK/PD modeling and innovative, as well as traditional biostatistical approaches to all outcomes assessed. Never developed in isolation, all OBMRC-sanctioned protocols are fully vetted through the operational components of the organization and no protocol or proposed program is recommended without full knowledge of logistical and financial implications in addition to the clinical and regulatory implications.

Last update: 07/7/2015 11:24
Content updated on Monday, 10-2-2017 04:35:40 am